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

By: Brian Dolan | Mar 12, 2013        

Tags: | | | | | | | | |  |

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.

Advertisement

GlowCaps now sold through CVS, new randomized control trial launches

By: Jonah Comstock | Mar 11, 2013        

Tags: | | | | | | | | |  |

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 Amazon.com, 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 CVS.com 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        

Tags: | | | | |  |

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        

Tags: | | | | | | |  |

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.

Kentucky primary care provider launches MeVisit after two-year study

By: Brian Dolan | Mar 9, 2013        

Tags: | | | | | | |  |

MeVisitDr. William “Chuck” Thornbury, the CEO and Medical Director of Medical Associates of Southern Kentucky, gave one of the livelier and more passionate presentations at HIMSS13 this week. The Glasgow, Kentucky-based primary care doctor discussed how offering his patients online visits and consultations over the phone has helped him mitigate the primary care provider shortage in his area — and how a simple setup like that could help primary care providers meet increasing demands around the country — while cutting costs.

Thornbury told MobiHealthNews in an interview following his presentation at HIMSS that the idea for “mobile e-visits” came after he trained in the “lean” strategy principles pioneered and championed by automaker Toyota, at the University of Kentucky three-day Lean Executive Leadership Institute program. After attending the program a few days ago Thornbury’s team began discussing ways to fix the growing problem of having so many patients that they had to turn people away.

After trying real-time online visits with patients, Thornbury decided the process was too cumbersome and that a more elegant solution would only require that he or another physician use their smartphone. The patient could have the flexibility to access the online questionnaire via their PCs or mobile devices. In Thornbury’s practice most patients do choose to use their home or office computer, he said.

Thornbury began a one-year study of the offering, which asked established patients to pay $32 per e-visit in lieu of an in-person visit at his clinic. Patients were educated about the service’s availability via handbills, websites, and telemarketing. Thornbury made the service available 24 hours, which is why sending it to his phone was crucial. After patients filled out a form online, a brief call (2 to 3 minutes on average) was scheduled with the doctor, who could then complete an assessment and contact the pharmacy if need be.

Thornbury noted that while the median age of the patients was about 43 years old, the range was from 16 to 89 years old. Typically, those on the older end of the spectrum were using the service with the help of an adult child, he noted. Perhaps not surprisingly, 78 percent of the e-visits took place after his normal office hours, however, very few patients contacted him very late at night. Thornbury said he believes his patients understood he worked hard and did not want to disturb him if it wasn’t absolutely necessary.

In all, Thornbury studied the mobile e-visits offering at his practice for two years and believes the results are glowing. After two years, about 20 percent of his patients are using the service. At that adoption level, Thornbury said he has increased his capacity by 15 percent, which enables him to provide care for more patients or spend more time with those that need it. He said it works out to about an extra hour in his day. He also claims that the system has lowered per capita cost by 15 percent in his practice.

Interestingly, Thornbury has only used video visits on a handful of occasions over the past few years.

“If I really need to see the patient, I just ask them to come visit me in-person,” he said. “Our platform allows for up to five photos that the patient can include, too.”

Thornbury has leveraged his experience and the two years of study to launch a startup, called MeVisit, to make the platform available to other physicians.

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

HIMSS13 Roundup: Nuance, AT&T, AirStrip, Philips

By: Brian Dolan | Mar 9, 2013        

Tags: | | | | | | | |  |

Vidyo Healthcare PhilipsNuance’s MD survey on voice-enabled, virtual assistants

Ahead of the big event in New Orleans, Nuance Communications surveyed 10,000 doctors in the US about how virtual assistants, think Apple’s iPhone voice query tool Siri, might affect healthcare. Based on the survey, 80 percent of US physicians believe that they will “drastically change” how they interact with and use EHRs and other healthcare apps within five years. Of course, that is Nuance’s flagship product for healthcare — voice input.

The survey found that about 65 percent of physicians believe a virtual assistant would provide them with more accurate, timely information to support care or alert them to missing information in records and 80 percent believe virtual assistants will help patients by engaging them in the care process and helping them develop healthier behaviors. Read More

AT&T to power cellular-connectivity in Numera’s Libris mPERS offering

AT&T announced at HIMSS that it would provide M2M cellular connectivity for a mobile personal emergency response system (mPERS) it is developing with Valued Relationships Inc. and Numera Libris. Like other wireless-enabled mPERS systems, AT&T’s would automatically send for help when a fall is detected. Read More

TigerText offers up secure messaging API to mobile health developers

At HIMSS secure messaging vendor TigerText announced that it has begun offering an API that enables developers to add its secure messaging to their mobile health apps. TigerConnect is an “open API that lets any organization use the power of secure messaging to reach any colleague, customer or partner in real-time,” according to the company. TigerText already has API integrations with Dropbox and SpotMD. Read More

AirStrip One launches for cross-platform, mobile-enabled EHR, HIS interoperability

Ahead of the HIMSS13 event, AirStrip Technologies announced the launch of its AirStrip One offering, which is first being implemented at Dignity Health. AirStrip describes the offering as an “enterprise-wide, data- and vendor-agnostic mobility solution to securely deliver patient data from medical devices, electronic medical records (EMRs) and patient monitors to clinicians anywhere across the care continuum.” AirStrip describes it as a key to mobile healthcare interoperability. Read More

Meritus Medical Center taps PatientSafe Solutions for mobile health rollout

PatientSafe Solutions, which offers iPod touch-based point-of-care platform called PatientTouch, announced that Meritus Medical Center in Maryland had tapped it to implement PatientTouch throughout the 272-bed hospital. Read More

Philips and Vidyo expand partnership for video-enabled remote patient monitoring

At HIMSS13 Philips announced that its IntelliSpace eCareManager 3.9 will incorporate Vidyo’s VidyoRouter technology to better enable remote video monitoring of patients who are in the hospitals or at home. Read More

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