How the government regulates fitness apps

By: Brian Dolan | Oct 13, 2011        

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Brian Dolan, Editor, MobiHealthNewsThe Wall Street Journal published a report  last summer that questioned whether “toning” sneakers like Skechers Shape-Ups or Reebok’s EasyTones really help users get in better shape. The article included two links to case studies on the respective sneaker makers’ sites that touted the various fitness benefits provided by the sneakers. The sneakermakers actually asked the WSJ to update the article with those links to better tell their side of the story.

Neither of those two links work anymore.

That’s probably because the Federal Trade Commission complained that Reebok had made unsupported claims in advertisements for the shoes.

“In its ongoing effort to stem overhyped advertising claims, the Federal Trade Commission announced that Reebok International Ltd. has agreed to resolve charges that the company deceptively advertised ‘toning shoes,’ which it claimed would provide extra tone and strength to leg and buttock muscles,” a press release posted on the FTC site last month stated. “Reebok will pay $25 million as part of the settlement agreement. The funds will be made available for consumer refunds either directly from the FTC or through a court-approved class action lawsuit.”

The FTC alleged that Reebok made false claims, including that “walking in EasyTone footwear had been proven to lead to 28 percent more strength and tone in the buttock muscles, 11 percent more strength and tone in the hamstring muscles, and 11 percent more strength and tone in the calf muscles than regular walking shoes.”

While not mentioned by the FTC, Skechers also took down the case study for its toning sneakers, so I assume they got the hint.

About three weeks before the Reebok announcement, the FTC forced two “acne cure” smartphone app developers out of the Apple AppStore and Android Market for making certain health-related claims without scientific evidence.

Skechers actually has a companion iPhone app called Skechers Fitness Tracker that promises to make “tracking your workouts in Skechers Shape-Ups effortless” and uses the “iPhone’s built-in GPS technology to track your walking, running, cycling and hiking activities.” As far as we can tell, the app’s description never made claims similar to the ones that the FTC complained about and, as a result, appears to have survived the fallout unchanged.

Still, it’s clear that the US Food & Drug Administration (FDA) is not the only regulator that need be considered:

“While the current conversation around mobile health regulation has focused on whether a mobile medical app meets the FDA’s definition of a medical device, these recent moves by the FTC make clear that health and fitness app and device developers also need to be careful about the kinds of claims they make,” Robert Jarrin, Senior Director, Government Affairs for Qualcomm and Co-Chair Continua’s US Policy Group told me in a recent interview.

I think these recent moves by the FTC show that the regulator is paying attention to fitness and health claims, however, as our recent Consumer Health Apps for Apple’s iPhone report found, there are some 9,000 such apps available for the iPhone alone. How will the FTC monitor them all? The acne apps and the toner sneakers may be the exceptions since they both received considerable attention from various media outlets.

A new app called GlassesOff is set to become available to iPhone users some time next year. The app developer, Ucansi, claims that the program “can help you achieve over 80 percent improvement in vision acuity.” Wow. Given that CBS News is one of the first media outlets to report on the app pre-launch, they better be prepared to prove it works as advertised to the FTC, while proving it doesn’t work like a medical device to the FDA.

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Walgreens lets customers order refills via SMS

By: Chris Gullo | Oct 12, 2011        

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Walgreens prescription text alertsWalgreens recently announced the launch of an SMS reminder system for prescription refills. The free service reminds patients about medications due for a refill and makes it easy for them to replenish their meds: Patients need only reply “refill” to the reminder text.

Walgreens already offers a Prescription Ready Text Alerts service, which notifies customers when a prescription order is ready for pickup. It launched in March of 2010 and counted 1 million users a year later. According to the company, the service now counts more than 2 million users.

Walgreens also has a smartphone app, Refill by Scan, that (fittingly) refills applications by scanning the bottle’s barcode. It also counted one million users this March after launching last November.

“We’ve driven strong adoption and customer engagement through our mobile applications, and these mobile pharmacy features are also great tools for helping people manage their health,” stated Sona Chawla, Walgreens president of e-commerce, in a press release. “This is another way we’re extending the access to Walgreens pharmacy to patients on the go and helping them stay well.”

“Medication non-adherence is one of the biggest hurdles in treating illness today, responsible for more than $100 billion each year in avoidable hospitalizations3,” stated Cheryl Pegus, Walgreens CMO, in a press release. “Personalized services that can help patients remain compliant with their prescription regimens can be effective in lowering health care costs and improving patient care.”

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Read the press release below. Keep reading>>

St. Jude adds mobile alerts to implantable device monitor

By: Chris Gullo | Oct 12, 2011        

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merlin_at_homeSt. Jude Medical announced new features for its remote patient monitoring offering, Patient Care Network (PCN), including mobile alerts for physicians and improved data export to EHRs.

Mobile DirectAlerts, a notification system for iOS, Android, and BlackBerry devices, enables physicians to receive messages whenever a patient triggers the device’s alert system.

In addition, an Auto EHRDirect Export feature transmits data from the Merlin@home device directly to a clinic or hospital’s EHR system using the IDCO (Implantable Device Cardiac Observation) profile, “an industry standard for the transfer of information from an interrogated implantable cardiac device to information management systems.”

The Merlin@home device first received wireless support in May 2010: St. Jude Medical launched a wireless USB adaptor for its Merlin@home transmitter for patients with implantable cardiac devices last spring. The new adaptor allowed important patient data from the patient’s implantable cardiac device to be wirelessly downloaded and securely transmitted via cellular networks to a physician for review. Previously Merlin@home required a landline telephone line.

“Our intention with these PCN updates is to make the collection and utilization of patient and device data as convenient as possible for physicians managing patients with complex cardiac conditions,” stated St. Jude Medical Cardiac Rhythm Management Division president Eric S. Fain, M.D., in a press release. “As hospitals are increasingly focused on implementing robust EHR systems, this upgrade shows our commitment to offering physicians the technology necessary to provide efficient and secure solutions for the transfer of health data into those systems.”

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Read the press release below. Keep reading>>

Wireless sensors, tablet computer measure Parkinson’s tremors

By: Neil Versel | Oct 12, 2011        

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Kinesia HomeViewParkinson’s disease is considered a movement disorder, so it lends itself quite well to mobile technologies. At least one tablet-based device to measure Parkinsonian tremors is already on the market, while an iPhone measurement system passed muster in a clinical trial more than a year ago.

Two weeks ago at the AdvaMed 2011 medical technology conference in Washington, D.C., Great Lakes Neurotechnologies, headquartered in Cleveland, demonstrated its Kinesia HomeView device. Kinesia HomeView, which has FDA clearance in the U.S. and also has been approved for sale in several other countries, combines wireless sensors and a touch-screen tablet to help patients and physicians assess whether medications and/or neurostimulation therapy are working properly.

There haven’t been many new, widely prescribed treatments for Parkinson’s lately, so physicians generally treat the disease with a drug called levodopa (commonly called L-dopa) to address stiffness, tremors, spasms and loss of muscle control, and deep brain stimulation (DBS), a surgical procedure for more advanced cases of tremors. It is an inexact science, because Parkinson’s can manifest itself in different ways.

“These diseases, when they’re treated with drugs and also with neurostimulation devices, the body goes through what’s called acclimation,” Great Lakes Neuro CEO Robert Schmidt explained in a video interview at AdvaMed 2011. “You need to be able to continually update your medication.”

With Kinesia HomeView, the patient takes home a motion sensor worn on the finger, plus a touch-screen tablet that includes videos explaining how to take Unified Parkinson’s Disease Rating Scale tests. The tablet gives reminders to take the test several times a day, and then measures tremors and, with a built-in camera, records videos of patients taking the test.

Patients can keep a diary of their symptoms on the tablet, too.

Via a Web portal, physicians get a report out of the system that shows the types of tremors and the time of day of each test. Users can press color-coded dots on the screen to watch video of tremors. Another click brings up data from the sensor’s gyroscropes showing movement accelerations, data that can help with balancing medication regimens or programming deep-brain stimulation and provide quantitative measurements to assist with development of clinical trials, Schmidt said.

The usefulness of this type of technology was shown in a paper presented at the 2010 International Conference of the IEEE Engineering in Medicine and Biology Society, in Buenos Aires. Biomedical engineers from UCLA built a wireless accelerometer app that takes advantage of the gyroscope sensors built into the iPhone.

“The initial testing and evaluation of the iPhone wireless accelerometer application for quantifying Parkinson’s disease tremor successfully demonstrates the capacity to acquire tremor characteristics in an effectively autonomous environment, while potentially alleviating strain on limited and highly specialized medical resources,” they concluded.

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CTIA: 96 million smartphones in US

By: Chris Gullo | Oct 12, 2011        

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iPhone 4SThere are currently 96 million smartphones in use in the US, an increase of an incredible fifty-seven percent from this time last year, according to CTIA’s latest survey, which it unveiled this week at their annual event in San Diego. In addition, the number of wireless subscriber connections recently surpassed the number of people in the US for the first time. There are currently 327.6 million wireless connections in the US (a nine percent increase from last year) and 315.5 million US residents. (CTIA counted some 50 million active smartphones in their survey from March 2010).

Other metrics from CTIA’s most recent survey include:

  • The number of active data-capable devices is 278.3 million, up from 264.5 million last year (5 percent increase from mid-2010).
  • There are 15.2 million wireless-enabled tablets, laptops and modems, up from 12.9 million last year (17 percent increase from mid-2010).
  • 1.138 trillion SMS messages were sent and received, up from 982.9 billion (16 percent increase from mid-2010).
  • There were 28.2 billion MMS messages, a decrease from 32.1 billion from mid-2010.

“CTIA’s semi-annual survey proves that Americans love wireless and continue to rely on the most cutting-edge and innovative devices and services in the world. Clearly, we’re using wireless more every day, and the consensus of experts is that demand will continue to skyrocket by more than 50 times within the next five years. These are the reasons why our members need more spectrum,” stated Steve Largent, President and CEO of CTIA, in a press release. “By making underutilized or unused spectrum available for auction, carriers will continue to invest billions of dollars in their infrastructure, generate hundreds of billions of dollars in benefit to our economy and create up to a half a million new jobs while ensuring the U.S. maintains its position as the world’s wireless leader.”

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Read the CTIA press release below. Keep reading>>

New mobile advertising network targets doctors

By: Brian Dolan | Oct 11, 2011        

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Tomorrow NetworksA new mobile advertising network that serves ads specifically targeted to healthcare providers launched this week. Physicians Interactive Holdings, which offers the popular Skyscape app, and stealthy Remedy Systems partnered to launch the mobile ad network, called Tomorrow Networks. The network launched with some 54 different smartphone medical applications having already signed on. Remedy Systems is providing developer relations and the technology behind the platform, while PI is contributing its sales channels, ad operations management, relationships with ad agencies, and a testbed in the form of its popular Skyscape app.

Tomorrow Networks is intended to be a revenue channel for those medical apps that haven’t monetized yet or those looking for an additional incremental revenue stream. According to the launch press release, Tomorrow Networks already claims to have an app user base of 275,000 healthcare professionals.

“If you are a healthcare marketer trying to reach healthcare professionals on mobile [devices], there has not been a scalable way to do that with display advertising thus far,” Physicians Interactive President Sanjay Pingle told MobiHealthNews in a recent interview. “Sure, there have been messaging opportunities and sponsorship opportunities in medical apps, but you have not been able to target cardiologists in Texas, for example. That has not been available historically, but Tomorrow Networks makes that possible.”

Of course, there are a number of mobile ad networks already available. Two high profile ones include: Apple’s mobile ad network called iAd and Google’s ad network, Admob.

“The only way that Admob or iAd can target healthcare professionals is based on other apps that the user is using,” Pingle said. “They guess you are a medical professional if you are using a medical dictionary app, for example. So, they serve you an ad intended for a medical professional.”

Tomorrow Networks, however, knows if the users of apps on its network are medical professionals. It’s beginning to learn much more than that, too.

“We have launched a number of initiatives to increase the amount of profile data we require from users before we provide them with free content,” Pingle said. “We know their profession, their specialty, and like most everybody else — we know their location.”

Pingle said with the granularity of user data that Tomorrow Networks has, the network can, for example, target ads to nurses who treat multiple sclerosis. Thanks to that precise targeting, PI and Remedy expect medical app developers to leverage Tomorrow Networks because it will enable them to charge advertisers higher premiums. Keep reading>>