Fitbit will lay off 110 employees, 6 percent of its global workforce, as part of a reorganization designed to save the company $200 million in operating expenses after the wearable leader underperformed in the fourth quarter. The Information broke the story yesterday, saying as many as 10 percent of Fitbit's employees might be laid off, but the company's announcement today confirmed the lower figure.

"Fourth quarter results are expected to be below our prior guidance range; however, we are confident this performance is not reflective of the value of our brand, market-leading platform, and company’s long-term potential," CEO James Park said in a statement. "While we have experienced softer-than-expected holiday demand for trackers in our most mature markets, especially during Black Friday, we have continued to grow rapidly in select markets like EMEA, where revenue grew 58 percent during the fourth quarter. To address this reduction in growth and what we believe is a temporary slowdown and transition period, we are taking clear steps to reduce operating costs."

The reorganization is a response to fourth quarter performance considerably under targets. While the full Q4 report and conference call will be held at the end of February, the company announced some metrics today, including that the company sold 6.5 million devices in the quarter for a revenue between $572 million and $580 million, compared to the company’s previously announced guidance range of $725 million to $750 million. For the full-year 2016, Fitbit expects an annual revenue growth of 17 percent -- 25 to 26 percent was forecasted.

Park and Chief Technology Officer Eric Friedman will shoulder some of the burden for the savings themselves -- according to Fitbit, the two intend to take $1 salaries in 2017. Park also stressed that he sees the shortfall as a temporary setback, but that the company's longterm roadmap should put them back on track. He also confirmed that the company has its eyes on the smartwatch market, something that's been the subject of much speculation.

“We believe the evolving wearables market continues to present growth opportunities for us that we will capitalize on by investing in our core product offerings, while expanding into the smartwatch category to diversify revenue and capture share of the over $10 billion global smartwatch market,” said Park. “We believe we are uniquely positioned to succeed in delivering what consumers are looking for in a smartwatch: stylish, well-designed devices that combine the right general purpose functionality with a focus on health and fitness. With the recent acquisition of assets from Pebble, Vector Watch and Coin, we are taking action to position the company for long-term success.”

Even more interesting to MobiHealthNews readers, Park stopped short of discussing a health device, but emphasized the importance of healthcare to Fitbit's longterm plans.

"Looking forward, we believe Fitbit is in a unique position to stimulate new areas of demand by leveraging the data we collect to deliver a more personalized experience while developing upgraded versions of existing products and launching additional products to expand into new categories,” Park said. “As the overall wearable category leader, we exited the year with an engaged community of over 23.2 million active users, making us uniquely positioned to be the partner of choice for the healthcare ecosystem, which is a key component of our long-term strategy.”

Austin, Texas-based EverlyWell, which offers a digital platform for consumers to order and provide samples for a suite of lab tests and receive results in an easy-to-read online report, has added tests for sexually transmitted diseases including HIV to their repertoire.

The new offerings mark EverlyWell’s move into testing for specific conditions and offering diagnoses. When they initially launched last September, the tests were geared at health and wellness, testing across eight different areas including food sensitivity, metabolism, women’s fertility, cholesterol and lipids.

“It’s always been a plan to bring as many proven tests to consumers as we could,” EverlyWell CEO Julia Cheek told MobiHealthNews. “We are responding to what consumers are looking for and what we can provide, and we found that people are really thinking about their sexual health and reproductive health testing.”

Citing a 2015 CDC statistic that showed STD rates in the United States are at an “unprecedented high,” Cheek said EverlyWell wants to make testing for them as hassle-free and frequent as possible.

“We’re becoming a known brand in consumer testing, and, frankly, we just need people who are sexually active to know we exist,” said Cheek.

The comprehensive STD test, which costs $249 and is covered by HSA or FSA accounts, covers diseases including HIV, syphilis, herpes type 2, gonorrhea and chlamydia. Like their other offerings, users order the test online and provide samples of either blood, urine or saliva, send it back to the lab and receive easy-to-understand results on a web platform. Tests that require blood are done so with a fingerprick lancet to provide a few drops of blood to a lab using validated panels. 

EverlyWell works with six certified labs to analyze their existing suite of tests. Molecular Testing Labs, which has an in-home STD collection test on the market for over a year with an accuracy of over 99 percent, will analyze EverlyWell’s new offering. In the case of abnormal results, a licensed physician will follow up, and users who test positive for a curable condition will receive a prescription for the appropriate medication. For those who receive a result for an incurable condition, physicians will also help guide them through the next steps.

“As opposed to our other tests that are lifestyle or supplement recommendations, we’re entering into a very different space,” said Cheek, noting that they have an added responsibility with this type of testing. “We have both a legal and ethical responsibility in terms of follow-up, and we uphold the same process as other STD testing organizations where we will actually hold results until we make contact with customers.”

The physicians who follow up all have experience in counseling those with potentially life-changing test results, and Cheek said EverlyWell modeled this service on the work of providers like Planned Parenthood. EverlyWell isn’t the first company to offer at-home testing kits for STDs and HIV, but they see their innovation primarily in the easily readable result format and overall consumer focus.

“Planned Parenthood had a very real role in promoting this type of at-home service and confidentiality, and they and other precedents really set the standard for how we designed our testing and follow up process,” Cheek said. “And while there are groups that have this product available, the challenge is that it is not so user friendly, and it may be hard to be able to trust.”

With the expanded offerings, Cheek said the company will be expanding their workforce as well. When they launched in beta in April 2016, they attracted 1,500 paying customers in just three months. Since their official launch, that number has grown to 5,000, and they expect to hit $1 million in sales this month. EverlyWell currently employs just seven people full-time (although bolstered by a large physician network and lab partners), so the company will be hiring more engineers and designers in the next year.

“In the next year, we will offer more tests, announce some exciting partnerships, and we are also looking at a subscription product,” said Cheek.

Along with making regular testing for STDs easier and less embarrassing, Cheek said EverlyWell is also responding to the rising uncertainty in whether certain sexual health services will continue to exist as they currently do. Additionally, they are trying to address coverage gaps people may experience.

“In terms of the political environment, we have done a fair amount of analysis with the potentially new, changing policies,” Cheek said. “If there are a large number of uninsured, we may see more people under HSA accounts, which we are covered by. Then we have customers who say, ‘I just want to go through you,’ as some services change and others may not have access. So we look forward to being parachutes for a lot of people.” 

VivaLnk, a Santa Clara-based connected health startup, has received FDA clearance for its first device, a peel-and-stick continuous thermometer for children called Fever Scout. VivaLnk announced Fever Scout at CES 2015 and originally planned to launch it that year, but has delayed the launch more than once. FDA clearance could mean the device will finally hit the market soon.

Fever Scout takes the form of a soft, flexible patch worn under an infant or child's arm. The device is designed to continuously monitor a child's body temperature and send the results via Bluetooth to a parent's smartphone. The patch has a rechargeable battery and a long range, allowing parents to monitor their child's temperature from up to 100 feet away.

The company has the patch listed on its website for $69, and sells replacement adhesives for $7.99 -- although at the moment, the product is not yet available to order.

VivaLnk may not be selling Fever Scout yet, but it's already promoting its second generation device, Vital Scout, which was announced at CES 2016, more than a year ago. While Fever Scout measures only temperature and is designed for children, Vital Scout uses the same eSkin technology to measure a wider range of vital signs, including ECG, for adults. It promises to measure body temperature, respiration rate, sleep status, heart rate, stress levels, and activity.

The first FDA clearance for a continuous thermometer like this went to Chinese company Raiing back in 2012. That device, originally aimed at the consumer, is now being used in enterprise contexts, including a pilot with Partners Healthcare a few years ago.

Fever Scout's FDA clearance comes at a time when baby tech, using connected devices to monitor infants for parents' peace of mind, has recently come under some scrutiny. In a JAMA article last week, researchers outlined how the proliferation of baby wearables that monitor vital signs and alert parents of abnormalities via a companion app can cause undue alarm to parents. Moreover, the researchers point out, the devices have no evidence of medical benefits.

How data gleaned from elite athletes’ wearables devices can be made profitable is still a largely unanswered question. But in the NBA, it's now been made clear one way that won't happen.

As SportTechie reports, the NBA’s Collective Bargaining Agreement specifically bans teams from using wearable data in contract negotiations or player transactions. While teams can use the data to monitor player health and performance and thereby adjust training or rest schedules, using that data to leverage any other decision-making is strictly out of bounds. 

“The data may not be considered, used, discussed or referenced for any other purpose such as in negotiations regarding a future Player Contract or other Player Contract transaction (e.g., a trade or waiver) involving the player,” the CBA states, adding if someone is caught doing just that, a designated grievance arbitrator will have the authority to impose a fine of up to $250,000.

The whole conversation over what to do with wearables started when teams started taking heat for frequently resting some of NBA’s most valuable players during scheduled games, irking fans and sponsors. Teams aren’t allowed to wear devices during games, but they regularly don them during workouts. The idea came up that data from wearables could also help coaches track exertion levels during the game and manage players more efficiently. Inevitably, it was suggested that data be used in contract negotions.

While the CBA doesn’t want to let wearable data play in discussions over contract negotions or player transations for now, it is open to the concept of their eventual use in games and potential commercialization. In December, it was announced that a new committee was in the works to reassess the value of and role wearables may play in the sport. The new committee – which will be made up of league officials and players’ union representatives – will decide if any devices will eventually be allowed during games, what data they will track, and how that data will be used. And, of course, whether there is a possibility of making money off that data.

Wearable activity tracker company Jawbone has been in dire straits for the better part of a year now, losing key executives, dumping its speaker business, reportedly selling out of its inventory (the company has fervently denied those reports), and not announcing any new products for several years. Last we heard, the company's planned hail mary was a more clinically-focused wearable, likely building on the company's 2015 acquisition of Spectros.

Now a new report from TechCrunch, citing anonymous sources, says the company isn't just building a medical wearable: its planning to completely discard its identity as a consumer products company and focus on selling enterprise devices to hospitals. The business will include both a product and a service component.

The move makes sense for Jawbone, which in addition to the Spectros IP and its own consumer devices, owns all the patents associated with Bodymedia's FDA-cleared tracker from its acquisition of that company back in 2013.

An 11-year-old company with at least six patents and numerous published studies, Spectros specialized in using spectroscopy to create a range of non-invasive molecular sensors. In particular, commercial applications of the technology used it for pulse oximetry, and detection of perfusion and ischemia. The company's On-Call remote monitoring product allowed doctors to monitor their patients using a smartphone. When Jawbone acquired Spectros in 2015, CEO David Benaron became Jawbone's Chief Medical Officer.

MobiHealthNews broke the news of the acquisition after hearing Benaron speak at a precision medicine panel at BIO International 2016 in San Francisco. His comments there might shed some light on what exactly Jawbone is planning in healthcare.

"We think of chronic disease as irreversible unless you take medications, but one of the medications is your lifestyle," he said at the time. "One medication is knowing early enough before the damage is done. It happens with hypertension, with diabetes, with stroke. If you know ahead of time, you can prevent these diseases. ... 24-7 vitals is the next thing in my view that’s going to fundamentally change things. If you knew heart rate and your body function and your respiration and your blood pressure and all the levels of all the things continuously through a patch or wearable, you would fundamentally know the earliest stages of disease. Not because you know for one person exactly what will happen, but because you have the data from everyone in the world, and you can find the patterns in the big data analysis and apply that to the small data about individuals."

Whatever Jawbone's plan is for entering the healthcare market, it's going to need to be lucrative -- the company has raised $950 million from various sources, and some of those raises have been reported to be debt rather than equity. Some of that money has gone to legal fees as Jawbone has been embroiled in a constellation of lawsuits in various jurisdictions against rival Fitbit. But likely quite a bit has gone into R&D. If the Spectros acquisition was tied to the clinical pivot, that means the pivot has been in the works for at least a year and a half, so Jawbone could have something to show for it very soon.

Fitbit's alleged theft of trade secrets from Jawbone, already the subject of a closed ITC case and an ongoing civil court, is being investigated in a third and more serious venue: a criminal grand jury probe, conducted by the Department of Justice and the Department of Homeland Security, that has been looking into the matter for five months, according to a new court filing by Jawbone. Bloomberg first reported the news.

Grand jury investigations are secret; the only reason this investigation has been made public is that Jawbone made the assertion in a filing in the ongoing civil case. Jawbone was responding to Fitbit's motion for a dismissal, arguing that the ITC judge had already investigated and dismissed the claims. 

"After a full examination of the issues and Fitbit's resounding victories at the ITC, coupled with Jawbone’s complete failure in the marketplace and reported insolvency, Jawbone is now attempting to exert leverage against Fitbit in civil litigation pending in the California state court," Fitbit said in a statement earlier this week. "Fitbit is cooperating with the U.S. Attorney's Office to demonstrate, once again, that these allegations are without merit."

The suit alleges that Fitbit sent recruiters after nearly a third of Jawbone employees, and that five of those employees took information about Jawbone’s current and future business plans and products with them on thumb drives. In the filing Jawbone describes one of its former employees as requesting a meeting with company executives to better understand the company's future strategy and get a look at prototype devices for future products. Weeks before leaving to join Fitbit, she then downloaded the presentation, which Jawbone said was its "Playbook for the Future" onto her personal computer.

ITC Judge Dee Lord dismissed the case in August, noting that "no party has been shown to have misappropriated any trade secret", but at the time the full text of her decision was not available because it was being redacted for trade secrets. The now-available document addresses each alleged trade secret in detail -- and shows that this could be a hard fight for Jawbone to win, unless the grand jury turns up new evidence.

In one, Lord says "Complainants’ allegations are so vague and contradictory that it is not possible to determine what constitutes alleged trade secret no. 98, much less to determine whether it was misappropriated. Moreover, Complainants’ allegations are contradicted by the factual record, which refutes any inference of misappropriation. Accordingly, Complainants have not satisfied their burden to make out a prima facie case of trade secret misappropriation."

For another, Lord writes "Complainants’ theory of how an alleged misappropriation may have occurred is highly speculative." She goes on to assert that there's also no evidence of Jawbone's having been financially harmed by the alleged trade secret appropriation.

More than two years ago, when Apple first added a list of diabetes management apps to its app store, we covered the list of 13 top picks. A lot can change in a few years, however. And while a few of those same apps still appear on Apple’s current list of 12 diabetes management apps, there’s plenty of new names — though not all new to MobiHealthNews readers — as well.

Read on for Apple’s current 12 picks for apps for managing diabetes.

One Drop for Diabetes Management: An FDA-cleared app, One Drop has both a free and a pro version, the latter coming with the company’s Chrome Meter lancing device and coaching services. On the companion app, users with type 1, type 2 or pre-diabetes can log a variety of information: glucose, diet, activity and insulin. Users can share that information anonymously with a community of users, and the platform also offers users actionable insights based on their data.

OneTouch Reveal: This companion app for the OneTouch Verio Flex meter, OneTouch Reveal comes from LifeScan, a Johnson and Johnson subsidiary. The meter sends readings wirelessly to the app, and users can use it to see current data and colorful charts depicting 14, 30, and 90-day summaries. Users can also share info with healthcare professionals via email or text.

Dexcom G5 Mobile: The first of two Dexcom apps on Apple’s list, Dexcom G5 Mobile allows users of Dexcom’s G5 continuous glucose monitor to see their readings, which are taken every five minutes, and share them. It also forwards trend alerts when a user’s glucose level goes too high or too low. It connects to HealthKit to send that data out to other apps that might need it, and can send data to five other users via Dexcom’s follow app (which shows up further down the list).

Blip Notes: Blip, from California nonprofit Tidepool Project, is a platform for aggregating data from different diabetes devices. Blip Notes is an important part of the platform because it allows the user to take qualitative notes about what was happening when a reading came up on a particular device. It supports hashtags to easily connect readings that happen in conjunction with a regular event like a particular meal or a sports practice.

mySugr: For people with Type 1 or Type 2 diabetes, mySugr helps them to track their food intake and blood glucose levels. The pro version adds coaching services and a bolus calculator, as well as reminders. The app is registered with the FDA as a Class 1 device. Over the past year, the company has partnered with both Abbott and Roche to integrate its popular app with their devices. 

Diabetes Kit Blood Glucose Logbook: Diabetes Kit Blood Glucose Logbook lets users track blood glucose, insulin dosing, food, HbA1C, blood pressure and activity. There are several ways to get that data into the app including entering it manually, integration with Apple’s HealthKit, and using the phone’s camera to take a picture of the glucometer screen. It also syncs with Dexcom CGMs and includes an insulin calculator.

Dexcom Follow: The second Dexcom app on the list is for friends and family of G5 users who can monitor their own glucose with the G5 Mobile app. A single Follow app can take in data from five different G5s, and can even send the data to a user’s Apple Watch.

Lose It!: Lose It! is a well-known nutrition tracking/ weight loss app that helps users track their diet and exercise and set and meet fitness goals. It’s probably included on Apple’s diabetes list because tracking diet is an important part of managing diabetes. A recently added feature, Snap It, lets users upload a food just by taking a picture of it.

Accu-Check Connect Diabetes Management App: This is the companion app for Roche’s Accu-Check glucometers. The app takes in data from Accu-Chek wireless glucometers and also includes an insulin dose calculator for users with a prescription. The app also integrates with Apple Health to help users log meals, insulin, exercise, medications, blood glucose, weight, blood pressure, and more in the app’s logbook.

Calorie Counter & Diet Tracker by MyFitnessPal: MyFitnessPal, which has been owned by Under Armour since early 2015, is a well-known and well-regarded app for tracking diet and exercise. It includes a database of more than 5,000,000 foods and connects with more than 50 apps and devices for tracking fitness. The app also includes a built-in activity tracker. It’s free, but the premium option costs $9.99 per month. Like Lose It!, this app is probably included on Apple’s diabetes list because tracking diet is an important part of managing diabetes.

GlucoSuccess: A ResearchKit study from Massachusetts General Hospital, GlucoSuccess aims to help people with diabetes learn how their behaviors affect their health. Participants track activity duration and intensity, diet information, blood glucose measurements, body weight and waist size, as well as glucose readings and diet information. Using this data, GlucoSuccess has been able to provide users with insights into how their fitness and nutrition data relate to finger-stick blood glucose values.

HelpAround Diabetes: HelpAround provides its Android and iPhone app users with a local support group of nearby helpers who could be of assistance if, say, a person with Type 1 diabetes shares in the app's forum that they don't have their supplies, are feeling a bit off, and need someone to help them out with a test strip, glucose tab, or even operating a Glucagon injection. We wrote about the Israeli startup behind HelpAround back in 2014.

Big box wholesaler Sam’s Club is wading into digital health territory via a new partnership with digital health kiosk company higi, offering free, self-service health screening to 622 Sam’s Club locations with pharmacies around the country.

Chicago-based higi’s kiosks allow users to self-check their blood pressure, pulse, weight and body mass index as well as integrate with over 80 health devices, activity trackers and apps. The information is stored on an online platform where, once creating an account, users’ vitals are gamified and converted to a single “HigiScore” that represents the user’s overall wellness. Users can access the platform online and through a mobile app to track their health over time.

This service builds on Sam Club’s existing free health screening program, which the company offers every month from January through October to members and the general public. The launch of higi took place last weekend, during Sam’s Club’s promoted “Healthy at Heart” screening event that included testing for total cholesterol, HDL cholesterol, blood pressure, body fact percentage, glucose and, in some locations, vision and hearing.

“Knowing how challenging it can be for some people to find the time to get a checkup, we believe higi’s self-service stations will be a great tool to complement our monthly health screening program, as they both help make it easier for people learn more about their health,” Jill Turner-Mitchael, senior vice president, Sam’s Club Consumables & Health and Wellness, said in a statement. “We also recognize the importance of using the latest technology to motivate people to live healthier lives, so our partnership with higi is a perfect match."

The health kiosk company has gained quite a bit of traction since founding in 2012. It officially launched at SXSW in 2013, and their kiosks are now deployed in thousands of stores across the country, including Whole Foods, CVS and Publix. In 2014, they partnered with Rite Aid to offer kiosks in 4,100 stores, and later merged with fellow kiosk company Stayhealthy. Last year, the company raised $40 million.

“We believe understanding and tracking your personal biometric data is key to living a healthy life, so we make it as easy as possible for people to do just that with our unique screening technology and digital platforms that interface with leading health devices, fitness trackers or apps that people are already using,” higi CEO Jeff Bennett said in a statement. “We are thrilled to be partnering with Sam’s Club to make these innovative resources available and to help more people be proactive about their health.”

In the 1970s at Stanford University, psychology researchers put children in a room with marshmallows to test their impulse control. The study, and its follow-up studies, are considered landmark explorations of the ideas of willpower and impulsivity. Now a group of researchers from The Feinstein Institute for Medical Research, Cornell Tech, and Sage Bionetworks -- supported by the Robert Wood Johnson Foundation -- are launching a "Digital Marshmallow Test", a smartphone-based study of impulsivity in adults.

"Impulsivity is really one of the underlying moderators of poor health outcomes, from the perspective of the onset of problems, obesity, pathological gambling, substance abuse, smoking, suicidal behaviors," Dr. Frederick Muench, director of Northwell Health’s Digital Health Interventions in Psychiatry, told MobiHealthNews. "Impulsivity and poor self-regulation is the number one symptom across all disorders in the diagnostic statistical manual. Looking at impulsivity in its own right has never really been done in a large-scale mobile study. Not only is it a predictor of whether someone is going to have a health-related problem, it’s a predictor of whether they’re going to get better."

Muench, Cornell Professor of Computer Science Deborah Estrin, and Cornell Senior Researcher in Residence JP Pollak collaborated on the study, which will launch simultaneously on Apple's ResearchKit and the Android analogue ResearchStack, developed by Estrin and Pollak. Muench stressed that what separates this study from the original marshmallow test is that the original test was about "trait impulsivity", a person's inherent tendency toward impulsive behavior. The smartphone allows for the study of impulsivity in context, not just among different people but at different times of the day, different amounts of sleep, and other contextual factors.

"Some of the work that we do is to collect as much data as individuals are comfortable sharing with us and try to put together these individual models, what are the specific contexts, specific triggers that lead to an individual being more compulsive," Pollak said. "These are the kind of models that don’t work on a population level but really work on an individual level."

The study isn't available for download just yet. Researchers are starting with a smaller pilot group of 120 individuals. This initial group will give researchers data about their moods, passively collected phone data, and even genomic data. But they'll also participate in various validated game-like tasks to gauge impulsivity.

"Once that study’s done we’re going to do an open ResearchKit study," Muench said. "We’re hoping to get as many people as we can, and one of the ways we’ll reward them is that we’ll have enough normative data that we can give people feedback on their scores in different contexts and situations and compare to an age and gender reference group."

The study continues to push the boundaries of the ResearchKit and ResearchStack infrastructures (collectively referred to as "ResearchSuite"). While most of the studies so far have focused on collecting physiological data, this study will demonstrate the potential of the technology for a psychological study.

In other ResearchSuite news, Mole Mapper, one of the first smartphone apps to use the ResearchStack infrastructure, made its data available to researchers today. Data from 2,798 users who uploaded pictures of their moles will be available to researchers via Sage Bionetwork's community research platform Synapse.

At-home testing kit company myLab Box has expanded its services with the addition of six new tests for sexually transmitted diseases, bringing the company’s total offerings to 10 tests sold in the United States.

The company launched the new tests in response to increasing rates of STDs in the country, along with the uncertain future of healthcare services under a new administration. The new tests cover Hepatitis C, Herpes Simplex 2, HPV, Mycoplasma, Syphillis and Ureapaslma, available to both men and women. They can be purchased on the company’s website or on most major ecommerce sites like Amazon or Walmart, and can be bought individually or as a combination kit.

“myLAB Box was created in large part due to the unstable healthcare climate in the US and what we saw as the need for alternatives to payer-based health systems,” Lora Ivanova, co-founder and chief medical officer of myLAB Box, said in a statement.

The company’s mantra is “Don’t stress, just test,” and its mission is to increasing testing rates by making it easy, affordable and discreet.  Users order the tests online, then collect their sample of either urine, a small blood prick sample or swab, (depending on the test), place it in the provided containers and mail it back in the self-addressed envelope to myLab Box’s certified lab partners. Results are available within days and accessible online with a simple dashboard. Those with positive results are offered complimentary telemedicine consultations with licensed physicians.

The service is similar to that of EverlyWell, which just launched its suite of STD tests. myLab Box's prices range from $189 (for a 4-test panel) to $399 for the full, 10-test panel versus EverlyWell’s 7-panel test for $249, and both are covered by HSA or FSA accounts. It has advantages that Planned Parentood or STD Check.com don’t have, like nationwide availability, an easy-to-read results dashboard, or sharing options.

“From affordable screening to complimentary physician consultations for positives, every aspect of the myLAB Box service is designed to be something a user can easily handle out-of-pocket and without complications,” said Ivanova. “The recent shake-up of our healthcare systems further deepens our resolve to grow our offering and develop a new hassle-free lab testing model. We believe this is not just great business, but a much needed resource to curb a widespread epidemic in the US today.”

Walgreens’ Balance Rewards for Healthy Choices program, a set of web, app and text-based programs designed to improve medication adherence, activity and immunization, among other things, may be simple, but it appears to be working.
 
In addition to high engagement rates with the app and positive reviews from users, Walgreens has found the use of its Balance Rewards program, which operates similarly to an airline miles-earning program, translates to real health improvement.

“Every second we fill a prescription from a mobile device scan, we get 8- to 10,000 pharmacy chats through the smartphone and we have over 40 partners on the platform,” Walgreens Digital Division Vice President Greg Orr said during a presentation at the Digital and Personal Connected Health event at HIMSS 17 in Orlando. “We’ve now had over 3 billion points awarded and over 1.25 million connected apps and devices and about $3 million in discounts given out to people purely from tracking their behavior.”

While the tracking isn’t clinical remote monitoring, it promotes self-awareness, Orr said. And as patients learn more self-awareness and interact with the Balance Rewards program more, Walgreens learns more about their customers.

“We have a lot of data at Walgreens that can be integrated, so we start with Balance Rewards Healthy Choices data only and ask, ‘What can I draw out from that?’” said Michael Taitel, Senior Director of Health Analytics at Walgreens. “We think of what we can segment from the population, then what we can merge with pharmacy data. We may have a million people looking at trackers and walking, but how do we blend that with data about diabetics? What about those with hypertension? I can look at what prescription they are filling and see with a pretty good degree of accuracy what condition they have.”

Sharing data from a collaborative study Walgreens conducted with Scripps Translational Science Institute, Orr said Walgreens found users vastly prefer automatic reminders and tracking compared to manual logging, from activity logging to medication adherence. 

The two organizations looked at activity tracking data from over 450,000 Balance Rewards Healthy Choices users, 315,000 of whom were first-timers. They found 77 percent of users manually recorded their activities and participated in the program for an average of five weeks. But those getting automatic activity-tracking from connected devices or apps stayed in the program for four times as long.

There was an initial, dramatic drop-off by about 50 percent of users by the third week, but numbers stabilized after that and those who remained tended to stay engaged.

“It drops off really quickly, and in some ways, that’s ok, because it’s an opportunity to engage those who stop participating,” said Taitel. “But the other half was still tracking, and they are tracking, on average, eight or nine activities.”

Walgreens is able to get robust datasets that show the digital extension of the pharmacy retailer’s capabilities is making a difference for those with three of the most common chronic conditions: diabetes, hypertension, and cardiovascular disease.

“We want to see how digital programs impact adherence, and then look at how adherence impacts their biometrics,” said Taitel.

Looking at the relationship between activity tracking and antihypertensive medication adherence among members aged 50 and older, those who were using the program improved their adherence by 12 percent.
 
“That movement is huge,” said Taitel. “That’s getting at the level of 80 percent adherence, which is what is considered a therapeutic dose.”

People enrolled in the Balance Rewards program were also more likely to keep up with their flu shots, the data showed. Compared to about 9 percent of a control group, 17 percent of those using a Balance Rewards program got a flu shot.

“That’s the difference of a more loyal, engaged patient group – they are almost 100 percent more likely to get a flu shot,” said Taitel. “Now, of course that is only tracking those who get their shots at Walgreens, so some people may be getting them elsewhere like at their doctor’s office or [a competitor]. We haven’t displaced these other options entirely.”

Taitel acknowledged that the data sets contain a lot of selection bias, and said Walgreens is looking to do more controlled studies wherein they are able to randomize by reaching people through email and text messages rather than the app, which is designed for everyone. That being said, Walgreen’s position as a retailer does offer another level of detail a traditional clinical study doesn’t.

“The unique asset of Walgreens is that we have this ability to look at point of sale data, “ said Taitel. “We can learn of more ways to engage them by what they are purchasing at the stores. So, say we already know they are diabetic and getting medication there, but what if they are also getting a lot of allergy medication? Or, what if they are buying a lot of potato chips even though they are on heart medication?”

The level of detail gets more complex from there, Taitel said.

“We have external data. We know where every patient lives, we can segment by census data, we can see educational levels … then we can look at the impact on their healthcare utilization and cost,” he said. “A lot of this is descriptive, but we do engage in a lot of studies that are empirical.”

Lenovo Health has joined forces with Orbita, a connected home healthcare technology vendor, to unveil a virtual home care system at HIMSS17 based on two recently debuted products: Lenovo Smart Assistant and Orbita Voice.

Lenovo's Smart Assistant, first previewed at the Consumer Electronics Show in January, is a voice-controlled speaker for the home that combines the Amazon Alexa voice platform with Lenovo styling and Harman Kardon speaker technology. Orbita’s Voice is a voice experience manager for healthcare that builds on other voice-assistant platforms like Amazon Alexa to enable intuitive, patient-centric home care experiences designed to improve patient engagement, care coordination and outcomes, the vendor said.

Integrating Orbita Voice with the Lenovo Smart Assistant is meant to demonstrate how natural voice assistant technology can help patients with chronic and post-acute care needs be more fully engaged in their wellness at home, the two vendors said. Enhancing a patient's ability to access and share information with providers, caregivers and family members contributes to improved care management, treatment adherence and medication compliance, the vendors added.

“There is a significant gap in the delivery of care; it’s not what happens when in front of your providers that’s most important, but what happens at home, making it a care setting,” said Tom Foley, director of global health solution strategy at Lenovo Health, in a statement. 

Voice is the user interface of the future and is transforming how healthcare executives think about patient engagement in home health care, added Nathan Treloar, Orbita president and chief operating officer.

Nokia is set to launch the rebranded Withings suite of consumer digital health tools this summer, including connected scales, blood pressure monitors, thermometers and activity trackers, which will all be under the Nokia name. At the same time, the company will debut the Patient Care Platform for chronic condition management and release an updated version of the Health Mate app, altogether rounding out the former phone company’s first delivery to the digital health market since acquiring Withings, a move that came shortly after they first announced they were eyeing the industry a little less than a year ago.

“This is what we have been working towards for last several months. We’re ready to travel to the mobile world,” Cedric Hutchings, Nokia’s VP of Digital Health, told MobiHealthNews in an interview. “It’s a completion of our acquisition and it’s a realization of what has been a shared vision of who we are in digital health. Now it’s really clear and consistent that we have come to users to the market under a single brand, and in doing so, we are moving a step further with the application and platform.”

The Health Mate app aims to provide users a holistic view of their health by collecting data from all the connected devices, and the big upgrade will now feature coaching.

“Health Mate already does track vitals, but we’ve redesigned it to generate new insights and make it easier to find devices, and we also took it a step further to build an in-site behavioral change program, which is really bringing the user experience forward,” said Hutchings.

The Patient Care Platform has been tested in a few places in Europe and is currently in use at the UK’s National Health Service in a 69,000-person study on remote monitoring for hypertension, and it has also been used by the American Medical Group Association in a 150-person study examining the role of self-measurement in helping patients lower their blood pressure The HIPAA-compliant platform integrates the full Nokia portfolio of connected devices to provide near-real-time data to patients and their healthcare clinicians to help support diagnosis, manage or prevent chronic illness, and ultimately deliver targeted care. It also syncs with the Health Mate App.

The products aren’t entirely new, of course. The company launched the connected scaleand a smart, FDA-cleared thermometerunder Withings last June, and also indicated they would look beyond the direct to consumer space with the announcement of a project with Helsinki University Hospital to develop remote patient monitoring solutions.

Since then, Hutchings said, the company has conducted research to gauge consumer awareness and readiness for Nokia as a digital health company.

“We’ve been quite comprehensive,” he said. “It is a very important and visible moment, and we are realizing very concretely that we are staying as a single and unified company.”

The connected devices will be available starting early summer 2017 on Nokia’s website and major retail channels including Amazon, Best Buy (US and Canada), Bed Bath & Beyond, and Target, and the redesigned Health Mate app will launch at the same time.
 

After building up the human component of their network of suicide prevention organizations, Facebook is now bringing in the machines: The social media company announced they have updated their suicide prevention tools with artificial intelligence to identification of those at risk as well as improve the reporting process and speed up response time.

On a company blog post from Vanessa Callison-Burch, Jennifer Guadagno and Antigone Davis (Facebook’s Product Manager, Researcher, and Head of Global Safety, respectively) described key features of the updates, which include the integration of their prevention tools with Facebook Live and a testing phase of AI-powered pattern recognition to identify posts likely to include thoughts of suicide.

“Based on feedback from experts, we are testing a streamlined reporting process using pattern recognition in posts previously reported for suicide,” the company stated. “This artificial intelligence approach will make the option to report a post about ‘suicide or self injury’ more prominent for potentially concerning posts like these.”

As Facebook tests that tool, employees will review posts flagged by the software and provide resources if the situation calls for it, even if no one has reported the post yet.

“We are starting this limited test in the US and will continue working closely with suicide prevention experts to understand other ways we can use technology to help provide support,” the company wrote.

The company is also testing a feature that allows people to connect with Facebook’s crisis support partners (National Suicide Prevention Line, Crisis Text Line, and the National Eating Disorder Association) via Messenger, and Facebook plans to scale the service as organizations are able to adapt to changes in communication volume.

The Facebook Live integration is available now, and allows those who are watching a friend’s live video that concerns them to reach out to that friend directly and report the video to Facebook, which will then step in and guide the person reporting the video in helping their friend. Those who share a concerning live video will also see a set of resources on their screen.

Facebook has had suicide prevention resources in place for more than 10 years, which they developed over the years through partnerships with organizations including the National Suicide Prevention Lifeline, the Substance Abuse and Mental Health Services Administration and Save.org. Initially, these tools offered a way for people to report a friend’s post if they believed the content of that post expressed suicidal intentions. In 2015, they added to additional resources for the person who posted the concerning content by giving them the option to reach out to a friend along with encouragement to connect with a mental health expert at the Suicide Prevention Lifeline. Last year, Facebook expanded those optionsglobally by making it possible for those reporting a post to reach out to that friend directly.

“There is one death by suicide in the world every 40 seconds, and suicide is the second leading cause of death for 15-29 year olds. Experts say that one of the best ways to prevent suicide is for those in distress to hear from people who care about them,” the company wrote. “Facebook is in a unique position — through friendships on the site — to help connect a person in distress with people who can support them. It’s part of our ongoing effort to help build a safe community on and off Facebook.”

After the latest in a series of successful quarters (with $171.2 million in revenue, up 31 percent year over year), DexCom is queuing up some big product launches. On yesterday’s Q4 earnings call, CEO Kevin Sayer provided more detail about the forthcoming G6 continuous glucose monitor as well as the first products to come out of DexCom’s partnership with Verily.

“In a year of much confusion and turmoil in the diabetes industry, DexCom grew revenues more than 40 percent, an annual increase of approximately $170 million in worldwide revenue, a number that's, quite frankly, more amazing than the percentage when you compare DexCom to everybody else in our industry,” Sayer said on the call. 

Good news from the FDA, which approved DexCom CGMs for non-adjunctive use, and CMS, which recently announced it will reimburse some CGMs including DexCom’s, has the company feeling bullish about the future, though Sayer admitted the CMS rule would likely not translate to profits for the company for a little while as the ruling kicks in and they adapt their sales strategy to target the Medicaid population.

But the biggest news on the call was updates on DexCom’s product pipeline. The company plans to release an updated version of the G5 transmitter, which is currently under review, later this year. The update will include a new, more reliable touchscreen receiver, a new insertion system and corresponding smaller transmitter, an Android platform, and additional app features including incorporation of insulin data.

The company is targeting its next generation transmitter, the G6, for a Q3 2017 FDA submission and a 2018 launch. 

“As I mentioned earlier, the early data from G6 has been very impressive,” Sayer said. “Assuming this performance is replicated in the pivotal trial, we believe G6 will represent the next major paradigm shift in continuous glucose monitoring performance standards. G6 will allow us to reduce calibrations initially and provide the foundation for our no-calibration technology.”

DexCom’s partnership with Verily is aiming to produce a tiny dime-sized CGM that requires no calibration and can be marketed to people with both type 1 and type 2 diabetes. Because that platform is based on G6 sensor technology, Sayers said, it can’t launch until after the G6. The company is anticipating that the first product to come out of that partnership will be commercialized by the end of 2018, with a second generation due out in 2020.

“We continue to conduct human pilot studies with first-generation device and we have completed our initial feasibility studies for the secondarily Verily product and remain excited about continued progress on our collaboration this year,” Sayer said. 

Sayer also indicated that the company is very aware of the recent surge of interest in smart insulin pens as an alternative to insulin pumps and is forging partnerships in both spaces.

"We're very bullish on the opportunity for smart pens," Sayer said. "...The real value in these systems will be integrating that insulin onboard information from a smart pen, together with our CGM data, in a single unified app on the phone. We can do some pretty powerful stuff there. So, when you start demonstrating outcomes with a smart pen together with CGM data and providing patients with dosing support information, behavior modification information, really, at a fraction of cost of some more complex systems, I think we really have a home run there."

It may not be the smartwatch competitor promised on a recent earnings call, but Fitbit did announce a new device today that combines the advantages of two of its existing trackers. 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.

In order to add heart rate to the Alta, Fitbit had to reduce the size and number of components in its heart rate sensor, the company said in a statement, making the sensor 25 percent slimmer than the one in the Fitbit Charge 2. The heart rate sensor enables the tracker to automatically detect exercise and to more accurately track workout intensity and calorie burn, and it uses little enough power that the device has a seven-day battery life.

“Alta HR and these powerful new sleep features demonstrate our continued focus on evolving our innovative technology to deliver deeper, more actionable insights to help our users improve their health,” James Park, cofounder and CEO of Fitbit, said in a statement. “The miniaturization of our PurePulse heart rate technology opens up exciting opportunities for future generations of devices and new form factors. Our advances in sleep will provide millions of users around the globe accessibility to invaluable insights that previously could be obtained only through expensive lab tests.”

The sleep tracking features, which use the heart rate sensor, include "Sleep Stages", which uses heart rate variability to provide the user with estimates about how much time they spend in light, deep, and REM sleep, and "Sleep Insights" which combines heart rate data with movement data to give users personalized advice and insights.

Sleep Stages was designed in conjunction with a panel of sleep experts from Stanford, Johns Hopkins, and the University of Arizona. Fitbit plans to submit data on the use of its sensors to detect sleep stages at SLEEP 2017, a major professional meeting of sleep specialists, later this year. 

“From helping maintain a healthy immune system, to preserving your cognitive functions and managing a healthy weight, your sleep – or lack of – plays a critical role,” Dr. Allison Siebern, a professor at Stanford University and member of Fitbit's expert panel, said in a statement. “Fitbit’s new sleep features use a scientific-based approach to show your sleep patterns over time, and provide you with validated, actionable guidance to help you make changes in your daily routine to achieve greater quality sleep – and in turn improve your overall health. Given the comfort and accessibility of this product, it’s one of the most valuable and useful sleep tracking solutions available to consumers outside of a sleep lab.”

Like previous trackers in the Alta line, the Alta HR will come in a variety of colors and styles, including designer lines from PUBLIC SCHOOL, Simply Vera Vera Wang and Tory Burch. The device will be available in retail stores and Fitbit's website starting in April (it's currently in presale online) for a base price of $149.95, with additional charges for the specialty band designs. Sleep Stages and Sleep Insights will also be available on other Fitbit devices when they launch some time in the spring.

Uber has made digital health news several times for partnering with healthcare organizations to provide transportation for patients. In fact, they announced a partnership with an NHS trust along those lines just yesterday. But in Saudi Arabia, Jordan, and Egypt, the company has a different kind of digital health partnership. The company has partnered with mobile medical app AlTibbi to make telehealth services available as a perk for drivers. The service will launch first as a limited pilot, but the company plans to launch it widely in those three markets.

“We are thrilled to partner with AlTibbi on this initiative,” Nader Museitif, Uber’s Middle East Head of Business Development, said in a statement. “This further highlights our focus on partner-drivers’ health and well-being, and also emphasizes our goal to working with regional organizations and startups.”

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SnakeBite911, an app for snake bite victims from BTG, has launched an Android version. We wrote about the app last year at Health 2.0. The app contains tools for identifying dangerous snakes, mapping snake sightings, and tracking the spread of venom. It also has a hospital finder and first aid tips.

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Azumio, which has made a number of health and wellness tracking apps, launched Calorie Mama AI, an app that enables calorie tracking by taking a picture of food with the phone’s camera. The app uses deep learning and neural networks, Azumio CEO Bojan Bostjancic told MobiHealthNews, and can identify thousands of foods. The company also released an open API called SNAP (Smart Nutrition Analysis Platform) that other developers can use to iterate on the technology. We wrote about a similar update from competitor Lose It! last year.

People who turn to WebMD in their quest for health information can now do so without lifting a finger  – they can use their voice, through a new integration with Amazon Alexa.

As of today, people who use the voice-assistant service can launch the WebMD skill on any Alexa-enabled device (such as the Echo, Echo Dot and Amazon Fire TV) and ask a question about a range of health-related topics including conditions, medication, tests and treatments. Alexa will respond with WebMD-sourced answers in easy-to-understand language. 

"Every month, nearly one-third of the total online U.S. population turns to WebMD's websites and apps in search of answers to their health-related questions, but now they have another option – and it's as simple as asking Alexa," WebMD Vice President Ben Greenberg, whose product team developed the new voice capabilities, said in a statement. "There are a number of reasons that voice-enabled interfaces are growing in popularity – they are generally hands-free, people can talk faster than they type, and when done right, they make it easier for consumers to quickly and easily get to the information they need."

As anyone with an Alexa-enabled or other voice assistant device knows, one can attempt to ask it anything and it will go searching across databases, but it won’t necessarily come up with a usable answer. The goal with the WebMD integration is to bypass a potentially misdirected search for health information by taking them right to the company's content library. Users launch the skill by asking in a certain format, for example: “Alexa, ask WebMD to tell me about type 2 diabetes,” or “Alexa, ask WebMD what is an echocardiogram.”

People can also request the information be sent to them in text form to their Alexa app, and that option will provide the original answer to their question along with a URL to a WebMD page that can offer more resources.

Alexa is a lot like many other apps, and has a free, self-service, open API for third parties to develop their own products on. To date, developers and companies have built more than 10,000 Alexa skills, an Amazon spokesperson told MobiHealthNews in an email. While the company couldn’t share any specifics, they said they are always looking to expand their capabilities, including health and wellness skills.

Amazon has racked up a few health integrations with its voice assistant since launching  About a year ago, the company teamed up with Fitbit to allow Alexa to inform users of the activity-tracking wearables about their sleep, activity and weight. In April, Boston Children’s Hospital officially launched its partnership with Alexa in the form of an app called KidsMD that gave the device the ability to give parents simple health advice about their children’s fever and medication dosing. Then, in December, connected home healthcare company Orbita began using Alexa, although not as their exclusive voice assistant. And just recently, at HIMSS 17, HealthTap deployed the Doctor AI app using Alexa.

“We're excited that WebMD is bringing its skill to Alexa," Rob Pulciani, director of  Amazon Alexa said in a statement. "With the WebMD skill, customers can get answers to health questions simply by asking Alexa. It highlights the convenience of a more natural spoken language experience."

Apple stores around the world and online are now selling the FDA-cleared smart blood pressure monitor from San Francisco-based wearable maker Qardio, marking the latest development in the digital health company’s ongoing relationship with the tech retail giant.

The QardioArm, which received FDA clearance in 2014, was an early integrator with Apple Health, as well as with the Apple Watch. The device runs $99 and works with iPad, iPhone and iPod touch. The two companies share some of the same sensibilities on consumer technology products – melding sleek design with approachable user interfaces.

“We’re thrilled to expand our global retail presence in collaboration with such a visionary retailer,” Qardio Chief Business Officer Alexis Zervoglos said in a statement. “We share with Apple an absolute belief that purity of design coupled with technological innovation drives change, as we focus on creating beautiful, accessible products that lead to a healthier world without compromising lifestyle."

Qardio, which debuted its blood pressure and heart rate monitor at CES in 2014, aims to not only be accurate, but also beautiful, so that it fits into the user’s daily life. According to Qardio, the device doesn’t look like a blood pressure monitor, which means users can carry it around in their purse or pocket without drawing attention to it. In fact, developers tried to make it look more like a notebook so that it looks like other items that potential users would carry around in their bag.

Qardio’s other devices include a wireless scale and the QardioMD dashboard for doctors. At CES, Qardio launched its wearable ECG monitor called QardioCore, which uses the company’s proprietary sensor technology that records more than 20 million data points that stream to a companion smartphone app.  The data can be shared with medical profesionals. The strap is worn around the chest and records continuous ECG, heart rate, heart rate variability, respiratory rate, temperature and activity data, and the strap can also work alongside Qardio’s other products.

The FDA is considering the creation of an Office of Patient Affairs, focused on soliciting the perspectives of patients and taking those insights into account as it sets regulatory policy.

The move grows out of a provision in the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law by President Obama in 2012. FDASIA instructs the HHS secretary to  "develop and implement strategies to solicit the views of patients during the medical product development process and consider the perspectives of patients during regulatory discussions." The FDA put out a request for comment in 2014 asking how best to satisfy this requirement, and is proposing the new office as a result of comments it recieved.

The agency wants to learn about patients' attitude toward the risk-benefit balance for new drugs and devices, wants to better understand how to most effectively solicit patient input, and wants to explore how to best support patients and their advocates in their efforts to understand regulation.

"To achieve these objectives, the Agency is considering establishing a central 'Office of Patient Affairs' which will be tasked with supporting and coordinating patient engagement activities across medical product centers and other offices that engage with patients and their advocates on matters pertaining to medical products," the FDA writes in the Federal Register. "In order to improve the transparency, coordination, and implementation of FDA's patient engagement activities, the responsibilities of this central office would include: offering a single, central entry point to the Agency for the patient community; providing triage and navigation services for inbound inquiries from patient stakeholders; hosting and maintaining robust data management systems that would incorporate and formalize knowledge shared with FDA by patient stakeholders and FDA's relationships with patient communities; and developing a scalable and forward-looking platform for communicating with patient stakeholders, particularly online channels."

In the digital health realm, the FDA has worked directly with patients in the past in cases where patients are DIY-ing disease management solutions, thus skirting traditional regulatory pathways. Last year, leaders of the Night Scout project for DIY diabetes management systems penned an editorial in JAMA detailing some of their experiences with the agency.  The FDA also waded into one of the biggest debates in the patient advocate community last summer when the agency issued guidance recommending that medical device companies give patients access to their own data. Similar cases to these could fall under the Office of Patient Affairs in the future.

Additionally, though, the FDA has always solicited and received input from patients, Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in the FDA, told MobiHealthNews. The problems are that (1) the FDA's mechanisms for soliciting feedback, like public comments online and at in-person meetings, haven't always been the easiest for laypeople to use, and (2) there has historically been a tendency in the agency to focus on hard data and write off patient experiences as anecdotal. Thompson thinks this could be a good way to surmount those obstacles.

"This office will be staffed presumably with people who are good at working with the general public, and explaining the FDA process, and engaging people in a true dialogue such that FDA can discern the real value in the patient experience and the patient perspective," Thompson wrote in an email. "At the end of the day, there are not simply correct and incorrect scientific conclusions based purely on scientific evidence. All of FDA's decisions are frankly laced with value judgments, and those value judgments are often predicated on what we think is best for patients. So what could be better than hearing from patients themselves about those value judgments? ... If done well, this initiative will do much to improve the communication and result in valuable intelligence and perspective gleaned from the patient community."

The FDA will collect comments on the proposal until June 7. However, a new commissioner under the Trump administration, which has made a point of cutting down the amount of bureacracy in the executive branch of the federal government, could stop the effort in its tracks.