AT&T funds AADE mHealth diabetes study

By: Chris Gullo | Sep 13, 2011        

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AT&TAT&T announced this week a collaborative study with The U.S. Department of Health and Human Services’ (HHS) Office of Minority Health and the American Association of Diabetes Educators (AADE) to evaluate the effectiveness of using mHealth applications for Diabetes Self-Management Training (DSMT) in underserved populations.

DSMT is a system in which diabetics and those at-risk learn the skills and knowledge to successfully self-manage the disease and its related chronic conditions through behavior modification. The study will take place within an underserved minority community in Dallas, Texas. AT&T donated $100,000 to the AADE to fund the study and will provide 150 smartphones to patients, diabetes educators and related personnel. The DSMT program will be delivered via a video-based app on the patients’ smartphones.

“Telehealth and mHealth have the potential to greatly increase access to health services such as DSMT, which has been proven to reduce complications associated with diabetes,” stated AADE Chief Executive Officer Lana Vukovljak in a press release. “This project is critical to evaluating mHealth and demonstrating whether it results in positive health outcomes comparable to face-to-face interactions. If so, it can be a solution to the challenge of providing diabetes education and meeting the needs of people in underserved populations with diabetes.”

AT&T also appointed Dr. Geeta Nayyar to its newly created CMIO position this week. Last year AT&T announced a partnership with WellDoc to pilot that company’s mobile-enabled diabetes management program among its employee population. AT&T also offers WellDoc’s solution to its customers as part of its its ForHealth portfolio.

Read the full press release below.

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AT&T names Nayyar chief medical information officer

By: Chris Gullo | Sep 12, 2011        

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NayyarAT&T announced this week the appointment of Dr. Geeta Nayyar to the company’s newly created Chief Medical Information Officer (CMIO) position. Dr. Nayyar previously served as Principal Medical Officer at Vangent and CMO at Apco Worldwide. Dr. Nayyar will take the lead of the company’s ForHealth strategy.

“Now is a particularly exciting time in the healthcare industry because technology is being embraced like never before,” Dr. Nayyar stated in a press release. “Stakeholders from payers to providers and consumers are recognizing the value that innovative health technologies can bring to challenges that have plagued our healthcare system for years.”

AT&T touts Dr. Nayyar’s “industry expertise in evidence-based medicine, health outcomes, disease management and wellness” and believes those will help her “translate healthcare issues and technology implications with a wide range of stakeholders including physicians, patients, providers, policymakers and consumers.” Given the convergence of mobile technology and healthcare, many large organizations working in mobile health depend on people like Dr. Nayyar to be able to talk the languages of each industry.

Nayaar holds memberships and committee appointments with the Healthcare Information and Management Systems Society, the American College of Rheumatology, the Association of Medical Directors of Information Systems and the American Medical Association.

AT&T has kept busy in the mHealth space, announcing partnerships over the last couple of years with a number of companies, including WellDoc, Vitality, and MedApps. It also recently entered the imaging space with a cloud-based service offering, AT&T Medical Imaging and Information Management service, which launched earlier this summer.

MobiHealthNews’ contributing editor Neil Versel interviewed Julee Thompson, whom Sprint recently appointed as its Chief Healthcare Executive.

Verizon Business, a part of Verizon, which owns 55 percent of mobile operator Verizon Wireless, used to have a chief medical officer — Dr. Peter Tippett. Dr. Tippett now holds the title of vice president research and technology in Verizon Business’ Security Solution’s group. Tippett also helms some of the telecom’s mobile health efforts: He recently announced Verizon’s move to make its universal identity service solution mobile-friendly.

Read the full press release about AT&T’s new CMIO below. Keep reading>>

Medco medication adherence app registered with FDA as Class 1 device

By: Brian Dolan | Sep 12, 2011        

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Medco Pharmacy smartphone appThis morning at the FDA’s public Workshop on its Mobile Medical Applications Draft Guidance, which it published in July, FDA senior advisor Bakul Patel noted that Medco had registered its smartphone app Medco Pharmacy App as a Class 1 medical device. The app became commercially available in mid-May and marked a collaboration between the pharmaceutical company and Verizon Wireless, which is offering the app in its VCAST application store. The app is also available for iPhone, Blackberry, and Android users.

Patel noted that the app is registered as a Class 1 medical device, which means it is among the lowest-risk medical devices.

Much of the discussion at this week’s workshop centered on to what extent medical app developers need to converse with the FDA.

The Medco Pharmacy App has three core features: listings of potentially lower cost drugs, medication tracking and alerts, medication risks alerts, and a prescription ID card.

Vocel, which developed The PillPhone app and received FDA clearance for it back in February 2006, also had partnerships for distribution among the major mobile operators in the US. PillPhone offers some of the same features as Medco’s app.

AT&T announced its distribution partnership for WellDoc’s DiabetesManager shortly after the company announced FDA clearance for its mobile health service, too.

Sure seems like checking in with the FDA is a prerequisite to get into a mobile operator’s pipeline.

CORRECTION: The original version of this article claimed that the FDA had given the Medco app “clearance,” however, as a Class 1 medical device the device maker need only register the device with the FDA. No process for “clearing” the device was necessary. Thanks to MedicalConnectivity.com analyst Tim Gee for pointing out the error.

Five medical apps the FTC will likely remove

By: Brian Dolan | Sep 9, 2011        

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AcneLightWavesThis week the Federal Trade Commission made an unprecedented move to remove two medical apps from the Apple AppStore and Android Market on grounds that they made unsubstantiated efficacy claims. The apps both offered “light therapy” to treat a user’s acne. Both developers were ordered to pay back the monies they made by selling the apps to consumers.

While app stores have offered a number of apps just like AcneApps and Acne Pwner over the years, there are currently only five such apps available for download.

We wonder why these apps have not been removed from the Apple AppStore considering their offerings are similar to the offending apps mentioned above. Of the five, only one is a free app — which may explain why it has been left untouched.

Given the action it took against the developers of AcneApp and AcnePwner, here are five apps that in our opinion the FTC is likely to remove from the Apple AppStore. I’d be curious to hear if anyone thinks one or more of these apps don’t belong on this list and why. Keep reading>>

US regulators remove two acne medical apps

By: Brian Dolan | Sep 9, 2011        

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AcneAppBy Brian Dolan and Chris Gullo

In a watershed moment, the FTC this week fined two app developers who falsely advertised that their smartphone apps could treat acne. The apps, AcneApp and Acne Pwner, were sold in the iTunes App Store and Android Marketplace, respectively. The settlements ban the developers from stating certain health-related claims without scientific evidence. AcneApp’s developer has to pay the FTC $14,294 and the developer of Acne Pwnder must pay $1,700.

AcneApp may have been removed from Apple’s AppStore as long ago as March 15, 2011 according to FTC documents. Acne Pwner may have left the Android Market last year.

“Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” stated FTC Chairman Jon Leibowitz in a press release.

“It’s surprising that FTC took this action, because it would have been more natural for FDA,” Bradley Merrill Thompson, the co-founder of the mHealth Regulatory Coalition told MobiHealthNews in an email. “I have had no knowledge beyond what I’ve read in the FTC press release, so I don’t know the company side of the story, but it would appear that the app would fall squarely into FDA regulation. Under the draft FDA guidance released in July, this would be an app that would transform a cell phone into a medical device, and thus fall within FDA’s jurisdiction.”

FDA’s draft guidelines actually specifically point to “apps that use the light source from a mobile platform to cure and treat specific conditions, such as acne” as one type of app that would be considered a medical device and subject to regulation under the proposed guidelines.

Both of the apps claimed that colored lights emitted from smartphones would reduce acne if held up daily to the user’s skin. According to the FTC, Acne Pwner was downloaded approximately 3,300 times from the Android store at a $0.99 pricepoint, while AcneApp secured approximately 11,600 downloads from the iTunes store at $1.99.

Shortly after its release in September 2009, AcneApp received press from The New York Times (December 2009) as well as Fox News (January 2010). Dr. Gregory Pearson told the NY Times that “this would have to go through a lot more clinical study before I could quantify its efficacy.” In the Fox news segment, Dr. Pearson said he couldn’t claim that the app offered any specific medical benefits: “I really can’t because those studies have to be done. But the idea, I didn’t just come up with it. It’s really based on some science.”

That “science”, according to the FTC, supposedly comes from a study in the British Journal of Dermatology that AcneApp falsely claimed proves that blue and red light therapy is an effective acne treatment. A dermatologist in the NY Times in the December 2009 article expressed skepticism as well: “In studies we’ve done, data has shown that both blue and red light have a low efficacy range in acne treatment,” Dr. Alexiades-Armenakas told them. “But it took dozens, and I mean dozens — 88 treatments — of the therapy, before we could see any results.”

According to MobiHealthNews’ AppStore archive, AcneApp’s description in the Apple Appstore as of February 2010 included a reference to plans for a clinical study of the app’s efficacy: “Baylor College of Medicine is gearing up for the first ever clinical trial of a phone based application, AcneApp. The Baylor study is independent,” the description read. “This is a really big deal,” it continued.

Last February Kathleen Doheny of WebMDNews asked Baylor College of Medicine if any such study was planned or underway, but a spokesperson from the school told the publication that they couldn’t find anyone employed there who had such plans. This past March when the app was removed from the AppStore its description made no mention of the supposedly planned Baylor study.

By our count there were five other apps that offered similar acne treatment to Acne Away back in February 2010. Four of those apps are no longer available for download: Anti-Aging ($2.99) by United Holdings Group, Acne Clear ($0.99) by United Holdings Group, ($0.99) Skin Cleanser by United Holdings Group, and ($4.99) Dr. Acne by Diomedics. Diomedics’ Dr. Acne was the first app to use light treatment on acne since it launched in February 2009, about seven months before AcneApp.

Interestingly, LOL Software’s Acne Away ($0.99) app, which launched in January 2010, is still available for download. Back in February 2010 Acne Away’s description cited the same BJD study as AcneApp to back up its efficacy. The current description for Acne Away’s iPad app claims that the larger screen of the device makes for a 113 percent more effective “in fighting acne in most people.”

Including Acne Away there are currently five apps offering light treatments for acne in Apple’s Appstore: M&R Selected’s SkinApp (free), FunVid’s Acne Light Waves ($1.99), Luke Campbell’s Light Therapy ($1.99), and LightRx’s ZITzapp ($0.99).

Check out a slideshow of screenshots and descriptions of these currently available apps here.

Read the full press release from the FTC below. Keep reading>>

iHealth gunning for Withings with connected scale, baby monitor

By: Chris Gullo | Sep 8, 2011        

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iHealth Blood Pressure iPhoneiHealth told MobiHealthNews this week that it plans to launch two new products, the iHealth Digital Scale and iBaby Monitor. A separate company called iBaby, a partner of iHealth’s, created the baby monitoring device.

The products join iHealth’s BP3 Blood Pressure Monitoring System as competitors to Withing’s connected device offerings.

The iHealth Digital Scale records and uploads a users’ weight via Bluetooth to a free iOS app, then aggregates the data into graph form. iBaby’s Monitor allows parents to remotely monitor their children, also via an iOS app. (Competition in the fledgling baby monitoring space includes Evoz, which is being advised by a former Google Health alum.)

The new products stand as obvious competition to their French competitor Withings. Both companies’ blood pressure cuffs were announced at last year’s CES. The iHealth received FDA clearance in early February, whereas the Withings was not cleared until June.

However, there are some critical differences between the two scales’ offerings and strategies to date. Withings WiFi Body Scale, appropriately, uses WiFi to transmit data to the cloud, which is then accessed via an iOS app. The iHealth requires a user to have their smartphone or tablet to be close by to the scale since it transmits data via a Bluetooth connection. Withings has also pursued an aggressive partnership strategy by connecting with other companies’ wellness devices via open APIs, including RunKeeper’s Health Graph and Fitbit and Zeo. To date iHealth hasn’t made a move toward partnerships of that kind.

It will be interesting to see whether the iHealth scale and iBaby’s monitor will be sold in Apple Stores since both the iHealth BP3 Blood Pressure monitor and Withings WiFi weight scale are currently featured on Apple store shelves.

Both the iHealth Digital Scale and iBaby Monitor are expected to arrive in October.

(Updated to make clear that iBaby is a partner of iHealth and that the two products have not yet been officially announced.)