US regulators remove two acne medical apps

By: Brian Dolan | Sep 9, 2011        

Tags: | | | | | |  |

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>>

Advertisement

iHealth gunning for Withings with connected scale, baby monitor

By: Chris Gullo | Sep 8, 2011        

Tags: | | | | | | |  |

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.)

Soon-Shiong’s big rollup gets a name: NantWorks

By: Brian Dolan | Sep 8, 2011        

Tags: | | | | | | | | | |  |

Dr Patrick Soon-ShiongDr. Patrick Soon-Shiong announced that NantWorks is the name of the company that he has been building through a series of acquisitions over the past few years. Following the sales of two companies Soon-Shiong founded — American Pharmaceutical Partners (sold 2008) and Abraxis BioScience (sold 2010) — he has invested more than $400 million dollars in acquisitions, according to a NantWorks press release.

In February Soon-Shiong acquired GlowCaps maker Vitality for an undisclosed sum thought to be in the low tens of millions. Unclear whether GlowCaps will be a part of NantWorks.

It’s very likely, however, that a number of other Soon-Shiong investments were in companies that are now a part of NantWorks.

According to the NantWorks press release, “the range of technologies in the NantWorks portfolio affects the entire continuum of advanced communications… state of the art semiconductor chips, switches and encryption technologies, augmented reality, novel object and voice recognition technologies, broadband telecommunications services and ultra-low power remote monitoring devices.”

Let’s take those one at a time.

Dr. Patrick Soon-Shiong is a director and owner of Tensorcom, a fabless semiconductor company that is a big proponent of WiGig. Orang Dialameh, an executive at Tensorcom, joined Soon-Shiong on-stage during his keynote presentation at the CTIA event this past March where Dialameh demo’d technology from a different company, Ipplex, where he is CEO and Co-Founder. Ipplex offers a novel object recognition technology and augmented reality offering called LookTel, which in its first iteration uses a phone’s camera to help visually impaired users identify currencies and other objects. Soon-Shiong is also the largest shareholder in KeyOn Communications, which has a subsidiary called CommX that offers broadband telecommunications services. The Ultra-low power remote monitoring devices might include those Soon-Shiong plans to create along with UK-based Toumaz. In July Soon-Shiong announced plans to bring Toumaz’s wireless health sensor to the US in a joint venture with the UK-based company that could see Soon-Shiong investing upwards of $25 million. He had previously invested $2 million in the company.

Tensorcom, Ipplex, KeyOn, Toumaz US and maybe Vitality GlowCaps. Some of the likely constituents of Dr. Patrick Soon-Shiong’s recently named rollup, NantWorks.

More details in the press release below: Keep reading>>

Qualcomm launches ECG smartphone program in China

By: Brian Dolan | Sep 8, 2011        

Tags: | | | | |  |

Qualcomm ChinaQualcomm has partnered with Life Care Networks and the Community Health Association of China to launch a mobile health project in underserved communities in China to provide prevention services and care services for cardiovascular diseases. The project, which is part of Qualcomm’s Wireless Reach initiative, will make use of China Telecom’s 3G network.

According to the World Health Organization, cardiovascular disease is the leading cause of death in China and it accounts for 3 million deaths annually. From Qualcomm’s release:

With a grant from Wireless Reach, the Wireless Heart Health project is deploying a 3G-enabled cardiovascular screening and monitoring system, developed by Life Care Networks, for resource-scarce community health clinics in Shandong, Anhui and Sichuan provinces, as well as the Chongqing municipality. Community Health Association of China is assisting in clinic selection, project implementation and impact analysis.

The project will make uses of smartphones that have built-in ECG sensors, EMRs, and cellular-enabled workstations at the health clinics. The smartphones will automatically send the patient data to a cardiac specialist at a call center where doctors provide feedback to patients and clinic staff over SMS or a voice call. Physicians can remotely provide service for simpler cases or suggest a specialist follow-up in-person. Finally, Qualcomm expects to make some of the ECG-enabled smartphones available for patients to rent and take home.

The Wireless Reach project includes mobile health programs in Japan, Kenya, Peru, Philipines, Portugal, South Africa, the US and many other countries.

For more on the project in China, read the press release below: Keep reading>>

Is RIM on the ropes in healthcare, too?

By: Brian Dolan | Sep 8, 2011        

Tags: | | | | | |  |

Brian Dolan, Editor, MobiHealthNewsBy many accounts BlackBerry-maker Research In Motion is on the ropes.

Early last year RIM’s devices were far and away the most popular smartphones among US smartphone users. Analyst firm comScore found that the company had about 42 percent of the US smartphone market in February 2011. Apple, Google, Microsoft trailed.

Fast forward to July 2011: The Nielsen Company found that RIM’s marketshare in the US among smartphone users has dropped to 19 percent. Nielsen also reported that the number of consumers with smartphones has jumped to 40 percent of all mobile device users in the US. Smartphone adoption was at about 16 percent at the end of 2009.

In June, just before the most recent Nielsen smartphone report came out, RIM lowered its earnings expectations, which are due out in a few days time.

While RIM has lost its lead to Apple and Android device makers in the consumer arena, by many accounts it still has a stronghold in the enterprise. That was certainly true for their adoption rate among US physicians as of May 2010. Back then, Manhattan Research found that US physicians used BlackBerry devices more than any other smartphone.

That lead didn’t hold much longer.

Manhattan also noted last May that adoption of mobile devices was neck and neck with adoption of BlackBerry devices adoption among US docs. When it counted all Apple devices, meaning iPod touch devices and iPhones, the devices outnumbered BlackBerry device adoption among US physicians. In May of this year Manhattan reported that 75 percent of US physicians own some kind of Apple device (iPhone, iPod touch, or iPad). At the time 30 percent of US physicians already had iPads. RIM has not reported any adoption numbers among US physicians for its PlayBook tablet, but by some accounts adoption has been insubstantial.

Manhattan also noted in May of this year that Android devices are not faring much better than BlackBerry devices among US physicians. Interestingly, by our count the number of healthcare apps available for BlackBerry devices has tripled since last year. But the almost 1,000 health and fitness apps available to BlackBerry users today is still less than the number available to Android users this time last year. While it’s not all about numbers, it’s another sign that RIM has a ways to go to catch up.

At least one analyst believes RIM can still make a big comeback in the US.

“RIM is getting beaten up a lot, but I think people will give them another chance,” Gartner analyst Ken Dulaney told PC World. “RIM has to get apps optimized for its environment and get the user interface right for touch. Do that well, and the people will come.”

Health gaming reaches critical mass

By: Neil Versel | Sep 8, 2011        

Tags: | | | | |  |

Neil VerselVideo games are hot in healthcare right now.

A fringe topic not too long ago, the subject gained a sense of legitimacy in July, when publisher Mary Ann Liebert Inc. introduced a new journal called Games for Health: Research, Development, and Clinical Applications. The first issue is due out this fall.

That’s right, there’s now a peer-reviewed, scientific journal specifically examining the role video games can play in advancing individual and population health, the healthcare industry and personal wellness. And this week, Liebert announced a companion newsletter called Games for Health Industry Insider, which starts publication on Sept. 29. I can see both titles being good resources for MobiHealthNews.

If you think this is an anomaly or a journal that’s ahead of its time, may I remind you that the Journal of the American Medical Association published a paper earlier this year that said video games deserve “serious attention” in healthcare.

Adding further weight to the notion that gaming can be an important part of healthcare, the University of Missouri just released news about a study underway at the school that incorporates Microsoft Kinect motion-sensing technology to help prevent falls and spot other potential health problems in seniors. A related study uses motion sensors from widely available security systems.

Researchers from Mizzou’s Sinclair School of Nursing and School of Engineering installed Kinect for Xbox 360 in a Columbia, Mo., nursing home and gave wearable sensors to residents to help measure changes in gait, a key indicator of the likelihood of falls. Additional sensors on beds were used to detect changes in sleeping patterns. Alerts get sent to nursing staff when there is a change that might signify a health issue.

“The potential that we’ve learned for early illness detection could revolutionize what’s happening in the way that we diagnose problems of older adults. We know from the research that we can pick things up 10 days to two weeks before critical health-change events happen,” nursing professor Marilyn Rantz said in a video released by the university.

Meanwhile, on Wednesday, Microsoft itself joined in. On the Microsoft HealthBlog, Dr. Bill Crounse, the Redmond Empire’s senior director for worldwide health, promoted the latest episode of Microsoft Health Tech Today, the company’s online talk show about how the company’s technology is advancing healthcare.

The subject of the newest video? Kinect.

Gaming in health—particularly mobile gaming—also is the subject of a forthcoming MobiHealthNews report. If you recall, Dr. Leslie Saxon, executive director of the University of Southern California’s Center for Body Computing, said last month that she’d like to take a mobile gaming app like Angry Birds and “diabetize it.”

Yes, we’re hearing a lot lately about gaming in health and healthcare. I don’t think it’s a coincidence. Ever since Nintendo debuted the Wii Fit as a fitness tool in 2008, gaming for health has started to break out of a niche and become mainstream. It seems as if we’re now reaching critical mass.