Simplee unveils billing tool for care providers

By: Jonah Comstock | Mar 12, 2013        

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simpleeSimplee, makers of an online tool that helps patients deal with medical bills and claims, announced SimpleePAY, a new service offered directly to healthcare providers.

When Simplee announced $6 million in first round funding last May, MobiHealthNews described their existing offering, the Simplee medical wallet, as a for healthcare, because it helps patients keep track of and make payments to different healthcare providers, as well as helping them avoid costly insurance mistakes.

SimpleePAY will extend those benefits to healthcare providers, with an online billing system. The platform includes an interactive digital bill that’s clearer and easier to understand than a paper bill, and will interactively incorporate an explanation of benefits. The system will give patients a range of payment options including mobile, installments, and discounts; pre-procedure cost estimates; and a loyalty program. The platform will be offered in three plans, with a scaling number of features: Select, Complete, and Ultimate.

“If you think about providers, consumer-driven healthcare is good for them as well,” co-founder and CEO Tomer Shoval told MobiHealthNews. “Years ago, they would get most of their revenue from government and from insurance. Now more of it [comes from] patients. If patients are confused or uncomfortable, it becomes a challenge for them.”

Shoval said that currently less than 5 percent of the $350 billion dollars spent on healthcare annually is paid online through digital payments. He said it costs providers an average of $10 per patient to make sure bills are paid via phone calls and snail mail. Simplee will enable more patients to pay their bills digitally. The platform also provides patient satisfaction surveys to help providers refine their payment processes.

“We do not believe in charging consumers, and we also believe that going D2C in healthcare is a challenge, and therefore our ability to go after the providers who have a direct relationship with the patients is important,” Shoval said.

The company is launching SimpleePAY with charter customer El Camino Hospital in Silicon Valley. (Clarification: An earlier version of the article referred to El Camino as a pilot. The hospital is a paying customer.) Other partners include Mutual of Omaha and health savings account provider ACS BNY Mellon.


FDA clears LifeScan’s long-awaited iPhone diabetes app

By: Brian Dolan | Mar 12, 2013        

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OneTouch Verio SyncAfter almost exactly four years, Johnson & Johnson company LifeScan has announced the launch of a Bluetooth-enabled glucose meter and companion iPhone app similar to the one the company showed off on-stage at an Apple World Wide Developer’s Conference in 2009 for the launch of iPhone 3.0. As MobiHealthNews exclusively reported following the Apple presentation, the LifeScan demonstration was really just a prototype at the time and no product launch was imminent. At the beginning of March the FDA cleared LifeScan’s OneTouch Reveal Diabetes Application with a 510(k). The company cited WellDoc’s DiabetesManager as its predicate device.

The new LifeScan app works with the OneTouch Verio Sync Meter and similar software is embedded in the OneTouch Verio IQ meter, according to the 510(k) summary document. The Verio Sync meter sends blood sugar test results directly to the app, which works with and Apple mobile devices running iOS 4+ operating systems, including iPhones, iPod touch devices, and iPads.

The app can store up to 2,500 blood glucose results and events and up to one year of results and events. The app synchronizes its time with the meter; makes it easy to tag meals and add notes; alerts the user of one or more patterns found in results once downloaded; enables user to manually enter data like results, carbs, activity, or medication; and allows user to share blood glucose results via text message or email.

LifeScan also tested the app with 168 trial users, including about two dozen children, at two different sites, according to its FDA clearance document. The studies were just to determine the app’s usability, and user feedback was overwhelmingly positive. (Read more in the PDF document over at FDA’s database here.)

At least one person from the original LifeScan team that helped put together that Apple presentation in 2009 is no longer with the company: Anita Mathew, the Lifescan executive demonstrating the meter at the Apple event, co-founded her own mobile diabetes startup, Glooko, in late 2011. Glooko developed a cable and companion app that connects a number of the most popular meters to Apple’s devices.

Of course, the most high profile iPhone-enabled glucose meter to have launched since the LifeScan demo in 2009, was Sanofi’s iBGStar, which AgaMatrix helped them develop. In December 2011 the FDA cleared the iBGStar, a tiny glucose meter that plugs directly into the the iPhone 3GS and iPhone 4+ devices’ connector port, and feeds data into an app on the device.

Does Fitbit’s WiFi-enabled Aria scale need FDA clearance?

By: Brian Dolan | Mar 12, 2013        

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fitbitariaIn January 2012 Fitbit expanded beyond wearable activity tracking devices when it launched its Aria WiFi Smart Scale at the Consumer Electronics Show (CES). While it offers much of the same functionality — if not identical features — to many of its peers, it is now one of the only connected weight scales that does not have FDA 510(k) clearance as a medical device.

Perhaps the best known WiFi-enabled weight scale is Withings’, which for a number of years sold through various retail channels, including Apple Stores, without a 510(k) clearance. Interestingly, the company secured FDA 510(k) clearance for its original weight scale (WBS-01) — just a few months ago — in September 2012. Like other 510(k) clearance documents for connected weight scales, the WBS-01 device’s clearance is focused on its method for determining body fat percentage and lean mass, bioelectrical impedance analysis or BIA.

As Withings explains in its 510(k): “This method measures body composition by sending a low, safe electrical current through the body. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed ‘bioelectrical impedance’, and is accurately measured by WBS01 Smart Body Scale.”

Because of the low electrical current used in BIA, Withings and others also note that their weight scales are not intended for use by pregnant women, children under the age of 18, or people who have implanted heart devices.

Withings’ two to three year wait to securing 510(k) clearance is also notable. Others in the connected weight scale space have had clearance since before they began selling their wares. Tanita and iHealth began selling their connected, BIA-equipped weight scales only after going through the FDA process.

Fitbit does warn in its user guide and (thanks to questions just last week) now in its help section that the Aria weight scale should not be used by people with pacemakers and that pregnant women should consult with their doctor first. The user guide further notes that: “Use of this device by people with an electrical implant, such as a heart pacemaker, is not recommended. Please consult with your doctor if you have questions regarding use of this device.”

Fitbit has so far refused to comment despite repeated inquiries.

GlowCaps now sold through CVS, new randomized control trial launches

By: Jonah Comstock | Mar 11, 2013        

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Vitality GlowPackLast month, Vitality made their GlowCap pill container caps available for direct-to-consumer purchase from CVS. The company has also been quietly developing a new product, the Vitality GlowPack, a customizable pouch which provides similar functionality to the GlowCap. The advantage to the GlowPack is that it can be used it for medications larger than pills.

CVS Caremark and Vitality GlowCaps are also working together to in a new randomized control trial using GlowCaps to test the effectiveness of sweepstakes to improve medication adherence.

GlowCaps, the music-making, glowing, cellular-connected caps designed to help people remember to take their pills, are a high-profile product in connected health. GlowCap lights up and plays music to remind users to take their pills and sends a signal to a reminder light. If the user still misses a dose, the system will call their phone. Also, GlowCaps sport a refill button that, when pressed, uses AT&T cellular connectivity to contact the user’s pharmacy to request a refill. The customer than receives an automatic callback to confirm the refill. A study with Partners Healthcare Centers for Connected Health in June 2011 showed that GlowCaps allowed a group of hypertensive patients to achieve 98 percent medication adherence.

The new study, led by the University of Pennsylvania, along with Carnegie Mellon University and Rutgers University, will include 800 high-cholesterol participants in four groups. Each group, including the control group, will use Vitality GlowCaps to remind them to take cholesterol-lowering drugs, or statins, but each experiment group will also be enrolled in a different kind of sweepstakes. For one group, participants will have the chance to win money each time they remember to take their medication. One group will be eligible to win only if they take their medication prior to be reminded. A third group will accumulate money in an account each time they successfully take their medication on time, but the account will only pay out if they reach a certain adherence level. Recruitment for the study starts this month and data collection for the study concludes in August 2016.

Vitality offered the WiFi-connected version of the GlowCap directly to consumer when it originally released the product in 2009, for $99 via, and distributed the AT&T cellular-connected version the same way in 2011. Shortly after that, the company was acquired by Dr. Patrick Soon-Shiong’s Nant Health.

At some point after the acquisition, Amazon stopped selling GlowCaps, and the company focused instead on selling to pharmaceutical companies and self-insured employers (having previously done pilots with at least four pharmaceutical companies). But, as MobiHealthNews mentioned in our recent writeup on medication adherence technology, the Wall Street Journal reported in January that the company would began selling via a major undisclosed retailer in February — that retailer seems to be CVS. The GlowCaps are available at for a discounted price of $59.99, with the regular price listed at $79.99. In addition, there is a monthly fee for the AT&T service.

The company’s new product GlowPack — which is at least a year old now — is a connected sealable pouch which can store blister packs, inhalers, injectable solutions, liquid medicines, and topical ointments. It is currently in beta, but the company is advertising the product to potential pilot partners. Like the GlowCap, the device glows and plays music when it’s time for a user to take his or her medication. It also communicates with the same reminder light that the GlowCap uses, and includes the refill button. The GlowPack has a replaceable battery and is also connected via AT&T. A demonstration video of the product, apparently intended for pharmaceutical partners, is available on Vimeo.

Airplane rescue, Colbert booking round out Topol’s HIMSS week

By: Jonah Comstock | Mar 11, 2013        

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Scripps Health Dr. Eric Topol

“We have sensors in our cars, why don’t we have sensors in our bodies?” Dr. Eric Topol, Chief Academic Officer at Scripps Health told the crowd at his HIMSS 2013 keynote address. “We could detect a heart attack before it happens.”

When Topol is on a plane, there are sensors there, too.

Just hours after delivering his speech, Topol was called upon to use the AliveCor Heart Monitor he demonstrated at the event to assist a fellow passenger in distress.

According to the San Diego Union-Tribune, Topol used the device to diagnose atrial fibrillation in a woman suffering from nausea and an apparent irregular heartbeat. He was able to calm and stabilize the woman until the flight landed as scheduled, according to the Union-Tribune.

“Diagnosed atrial fib, rapid VR for a woman in distress today on a plane at 30K ft, no emergency landing req’d,” Topol tweeted at the time. He also included a snapshot of the patient’s AliveCor readout.

Amazingly, this is the second time Topol has been in the right place at the right time, with an AliveCor heart monitor, to assist a heart patient on an airplane. The first was a year and a half ago on a flight from Washington, D.C. to San Diego. In that case, Topol diagnosed an imminent heart attack, and recommended the pilot make an emergency landing — which he did, somewhere in the vicinity of Cincinnati. The patient had a stent implanted and survived, according to a report in Medical Device and Diagnostic Industry.

“I guess this is really a sign-of-the-times about how useful these mobile medical devices can be,” Topol told the Union-Tribune on Tuesday.

A recent guest on our first MobiHealthNews podcast, Topol has been described variously as a digital health poster-child, an mHealth thought leader, and even a “rockstar of science.” Now he can add “two-time airline hero” to the list. Who knows what other names might emerge from his upcoming appearance on “The Colbert Report”, announced shortly after his airline ordeal. The interview, in which Topol will discuss his book, “The Creative Destruction of Medicine,” is scheduled to air on March 26th.

WebMD, Medscape to take on app prescribing, discoverability

By: Brian Dolan | Mar 9, 2013        

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WebMD MobileIf WebMD has its way, in a few years time it will be clear that one of the biggest announcements to come out of HIMSS 2013 was its partnership with Qualcomm Life. In an interview with MobiHealthNews, WebMD’s EVP & CTO Bill Pence explained that the initial partnership sees WebMD’s consumer sites and apps serving as a place to collect data from the health devices and services that connect to Qualcomm Life’s 2net platform. (Some 220 partner companies now partner with Qualcomm Life.) Pence said that WebMD’s mobile health plans go well beyond this partnership though.

“Tools and apps have been a focus at WebMD recently,” Pence said at HIMSS13 in New Orleans this week. “As we look at the evolution of wireless health and mobile apps, sensors are becoming increasingly important. Initially, consumer will use them on their own but soon these will be more tethered to physicians.”

Qualcomm Life’s Vice President of Global Strategy and Market Development Don Jones said that WebMD could shake up the patient-physician relationship, just as it did in the 1990s when patients began using WebMD to research their own health conditions and bring in printouts to share with their doctors.

“That same thing will happen again,” Jones said, “that same phenomenon will effectively repeat, but only this time patients will show up with their own data.”

Pence noted that WebMD’s mobile apps now have more than 16 million downloads. The company continues to rollout new mobile apps — just this week it announced the launch of the WebMD Pregnancy app. The newest addition joins a surprisingly short list of mobile app offerings from the company: its flagship WebMD Mobile app, the WebMD Baby app, and the WebMD Pain Coach app. While it’s clear the company sees opportunities in topic specific apps, WebMD is setting its sights much higher.

“Moving forward we can package any number of wireless health services under the WebMD brand,” Pence said. “We can educate people what wireless health is outside of fitness. For example, working with Qualcomm and [companies in the 2net ecosystem], we can suggest to consumers the top 12 best in class devices and apps for diabetes. We could enable them to buy it within the apps through a simple, seamless onboard process. Then we could help them gain insights from those devices and set their own triggers and thresholds and alerts based on their own data.”

Pence expects that WebMD’s flagship mobile app will have a curated mobile health store built right into it. While WebMD has a strong consumer user base, it also has a number of physician-facing properties with Medscape. Pence believes that the consumer-facing WebMD and physician-facing Medscape will come together to enable physician recommendations or prescriptions of mobile apps and wireless health devices.

“That will be the first connectivity solution to allow consumers and Medscape doctors to connect,” Pence said. “That platform will include a lot of different use cases, including the ability to prescribe apps.”

Pence said that mobile health has been “a cottage industry for a while” and WebMD’s contribution will not only be exposing it to a larger audience but also taking the pain out of it for consumers by layering in additional insights and actionable information alongside the data.

“This will accelerate the prescribing of apps — and remember — I define apps as any combination of hardware, software and pharmaceutical.” Jones said. “It will be consumer-driven, not top-down.”

MobiHealthNews coverage of the HIMSS13 event in New Orleans is sponsored by AirStrip Technologies.