How FDA and FTC co-regulate health apps

By: Brian Dolan | Mar 22, 2012        

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AcneAppDuring a panel discussion organized by the Office of the National Coordinator and the HHS last week, Federal Trade Commission Attorney Cora Tung Han, who works in the FTC’s Division of Privacy and Identity Protection and the FDA’s Policy Advisor Bakul Patel, who works at the agency’s Center for Devices and Radiological Health helped explain how the two organizations work together when it comes to regulating mobile health apps.

Han explained that the FTC’s broad mandate is to keep an eye out for unfair or deceptive acts or practices as well as false or misleading claims. Han said that includes acts or claims that cause or are likely to cause substantial harm to consumers that is not avoidable or counterveiled by benefits to consumers or competition.

Han noted that the FTC has already taken “enforcement action” against mobile health apps before: It “involved a case against marketers of apps that claimed to treat acne through a light emitted from the device if you held it close to your face. We alleged that those claims were unsubstantiated,” Han said.

MobiHealthNews covered the FTC’s takedown of the two iPhone and Android acne apps last year. At the time we wondered why the FDA wasn’t the agency to take action, since the FDA was on the cusp of publishing its proposed guidelines for mobile medical app regulation. It published those the following week.

“At FDA [we also] collaborate with FTC on areas that overlap in terms of the deception part that [Han] mentioned earlier,” Patel said. “We have a similar charge on our end which goes back to ‘misbranding’ of medical devices.”

Patel said that the FTC takes action when there is no “direct harm” posed by the medical apps to consumers. In those cases Patel said the FDA may “choose to have FTC take action” or do so themselves. They discuss to decide, he said.

“I’d like to echo [that],” Han said. “We do coordinate and talk and refer things back and forth. We try to reduce areas of confusion caused by overlapping jurisdiction.”

Han also pointed out that the FTC actually has jurisdiction for health breaches when the entities involved are not HIPAA covered entities, which led the FTC to carefully determine how best to work with HHS on health information breaches.


Like it or not: Consumer devices are in healthcare

By: Brian Dolan | Mar 22, 2012        

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MostashariLast week Dr. Farzad Mostashari, the National Coordinator for Health Information Technology at HHS, kicked off a half-day HHS event focused on privacy and security issues surrounding the use of mobile devices in healthcare. Mostashari’s comments summed up the mobile health opportunity for providers while pointing out the potential problems, too.

Mostashari described mobile phones as ubiquitous, connected platforms that are always with us and that “connect to the world’s knowledge”. He said these platforms can have a “near infinite number of applications” that can run on the hardware.

“That is when disruptive innovation — in the best sense of the word — is unleashed,” Mostashari said. “[It’s a] ubiquitous, connected platform. A ubiquitous, connected platform,” he stressed.

Mostashari noted that what is interesting about mobile technology is that unlike many of the innovations in medicine that start with the military or NASA and slowly trickle down to the consumer market, mobile technology innovations have started in the consumer market and found their way into healthcare settings.

“[This is] medicine, one of the most conservative bastions for adoption of technology — with good reason in many cases because the stakes are literally life and death… I heard [recently that] the military was using modified video game controllers for their arial unmanned vehicles. The same thing is happening in medicine,” Mostashari said. “Like it or not.”

“Increasingly, mobile devices meant for a consumer technology marketplace, are so usable, so pleasurable, so ubiquitous, so connected… that they are being increasingly used in healthcare,” he said. “And so we have to think about not only the possibilities but also the potential perils. Ubiquitous means you always have it with you, which means you can lose it at any time. Connected means that it’s not just the data on the device that could be compromised, it’s the data in the cloud that could be compromised. Platform means different applications have to be able to access the same data. Those, as we have seen and heard recently, there are vulnerabilities that could be introduced there. An application that you had no idea was accessing certain parts of your information [could be] tapping into your contacts, your locations. Each of those characteristics creates risks for privacy and security.”

Because of mobile’s increasing popularity among healthcare providers, ONC and HHS are looking to understand the related privacy and security issues that follow this unprecedented technology adoption trend. Mostashari noted that there is a connection to the meaningful use of electronic health records in Stage 2 meaningful use proposed rules. He also said that CMS stressed encryption as part of its proposed rule recently, too. The ONC proposed rule suggested that data kept on mobile devices should be automatically encrypted by EHR software, he said.

Mostashari described those as “small pieces of a much larger question about how can we ensure that we have done everything we can to maintain the privacy and security of health information wherever it sits.”

“One of the biggest difficulties we face is around authenticiation of individuals, making sure it is the right person accessing that information,” he said. “People have talked about two-factor authentication, not just something you know but something you are or something you have. If we do all have something in our hands, that too could serve as a second factor or authentication.”

Watch Mostashari’s talk here.

Mobile health at the clinic

By: Brian Dolan | Mar 22, 2012        

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Brian Dolan, Editor, MobiHealthNewsThis week MobiHealthNews is proud to serve up our latest report, Mobile Health at the Clinic, which explores the mobile apps and services currently offered at outpatient clinics, including retail, urgent care, and employer clinics. The report also delves into some of the mobile health services that these clinics are likely to begin offering in the near future. The complimentary report is available to download free of charge right here.

Here are a few excerpts from Mobile Health at the Clinic:

Mobile health tools promise similar benefits as clinics: lower costs and more convenient care. As a result, employer and retail clinics are perhaps the best-positioned healthcare facilities to drive adoption of mobile health services.

As new entrants like Walmart step up to build out retail clinics that provide primary care services, large employers continue to roll out on-site clinics, and existing retail clinic chains ink deals with local hospital groups to form collaborative care systems, mobile health services will have an increasing presence at the clinic.

It is likely a number of disparate primary care providers will adopt these connected health services, but none can match the scalability that Walgreens’ Take Care clinics, CVS MinuteClinics, or the many planned Walmart clinics can offer mobile health services. If any of these large national retail clinic chains decides to launch mobile health services at its clinics, they will immediately be one big step ahead of the majority of primary care providers.

While the number of retail clinics has not grown as quickly as most industry analysts predicted, the coming year could still prove to be pivotal for clinics. The opportunity for new services and revenue streams is ripe. New consumer health devices and apps enter the market each month.

The case for mobile health at the clinic is a compelling one. Full Report.

Fitness app developer Runtastic adds hardware

By: Brian Dolan | Mar 21, 2012        

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Runtastic Chest StrapGiven the recent influx of connected fitness devices that often offer their own companion smartphone apps, it may come as no surprise that at least one existing fitness app developer has decided to launch its own branded suite of devices to feed data into its app: Austria-based Runtastic. This week the company announced the availability of a GPS-enabled pulse watch and a heart rate chest strap.

Runtastic’s mobile app has now been downloaded 5 million times, according to the company. About 1.4 million downloads occurred this past January alone, according to Runtastic. The app is available for iOS devices, Android, BlackBerry, Windows devices and more. About 2 million Runtastic users have registered as users on the company’s online portal, The site is available in 7 different languages while the app is available in 15 different ones. The company launched in 2009.

“We have gotten a lot of feedback of users the last two years. It was a logical next step to integrate this knowledge in the development of our own fitness hardware. As an entrepreneurs view we are widening our value chain which will affect our growth strategy,” Florian Gschwandtner, CEO of Runtastic, stated in a press release.

The GPS watch tracks heart rate data and locations and does not require a user to have a smartphone. The chest strap tracks heart rate data that it wirelessly transmits to a tiny receiver peripheral that plugs into the user’s smartphone.

For more on the new hardware, read the press release below: Keep reading>>

Medical market is slow, steady for chipmakers

By: Brian Dolan | Mar 21, 2012        

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Toumaz Sensium Digital Plaster

Toumaz Sensium Digital Plaster

While the medical field has been a steady but slow growth market for chip makers, a recent report over at Chip Design claims that one segment of the medical market, remote patient monitoring, is picking up momentum. Broadcom, IMEC, Qualcomm, Intel, TI, Toumaz and other are angling to compete with new multimode wireless chips.

While adoption is still low, the race is on for a wireless standard to emerge for the body area networking (BAN) arena. Chip Design points to the emerging IEEE 802.15.6 standard, a low power version of Bluetooth, WiFi, and Zigbee as the top contenders. Toumax, IMEC, and researchers at universities are working on various new chips that would require less energy than those currently available. At least one of the chips under development will be powered by heat generated by the user’s own body, according to the publication.

According to research firm Databeans, the global market for medical semiconductors will increase from $3.8 billion in 2011 to $5.9 billion in 2016, which is about a 9 percent CAGR. This year the market will see flat growth and hit $4 billion, according to the research firm.

The medical market has three major segments for chip makers: clinical, imaging, and home health. While devices used in the clinical setting are the largest part of the market, home healthcare is the fastest growing segment since new devices beyond legacy blood press monitors, digital thermometers, and glucose meters are now entering the market.

Medtronic’s announcement to wireless-enable its CareLink remote patient monitoring service was a sign that the RPM arena was ticking up, according to the report. AirStrip’s recent deals with GE and Qualcomm also indicated an upswing in remote patient monitoring to the industry.

Overall, chipset makers said they need to get used to the slow pace of adoption in the medical field. One chipset executive told Chip Design that new system platforms in the medical field have IC design cycles that last as long as three years sometimes.

Many more details over at Chip Design

Ivor Medical’s iPad app explains how to use AEDs

By: Neil Versel | Mar 21, 2012        

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Ivor-AED-TranerThe iPad can’t administer a lifesaving electrical jolt to the heart – yet – but a new app teaches people how to do so with the help of an automated external defibrillator (AED).

Croatian emergency physician Ivor Kovic and his company, Ivor Medical, recently released the AED Trainer app, which simulates operation of an actual AED, the portable device that allows medical professionals, emergency responders and laypeople alike to shock the heart back into rhythm in case of cardiac arrhythmia.

The app, available through iTunes at an introductory price of $5.99, walks users through the processes of attaching electrical pads to the right spots on a patient’s chest, then, if necessary, delivering an electric shock from the machine to help restore normal heartbeat. The simulation mimics the display screen, buttons, sounds and voice prompts of a typical AED.

AED Trainer also allows instructors to generate custom training scenarios to help teach proper and appropriate AED usage, including how to administer CPR after delivering and electric shock. It is designed to work in concert with CPR mannequins and adhesive chest pads.

At press time, the product page on the Ivor Medical website was down, but the company has posted a video demonstration of AED Trainer here.

Kovic is a European champion of sorts for mobile technology in emergency care. Last year, he co-authored a paper in Resuscitation, the journal of the European Resuscitation Council, on the role of mobile phones in what he has dubbed the “chain of survival.” According to Kovic, phones obviously can be used to call for help at the first sign of an emergency and for post-CPR communications, but smartphones in particular also can assist in educating and refreshing the memory of rescuers about lifesaving actions people on the scene should take.

“[Mobile phones] have a potential to allow for a faster and superior emergency medical services contact, assure a higher quality of cardiopulmonary resuscitation (CPR) and quicker retrieval of an automated external defibrillator and facilitate a finer post-resuscitation care through telemedical and clinical decision support systems,” Kovic and a colleague wrote. “Smartphones, mobile phones with advanced computing abilities and connectivity, should be considered as medical devices, and their use, among lay rescuers and medical professionals in cardiovascular emergencies, further investigated and strongly encouraged,” they added.

Kovic discusses the “chain of survival” here.