FDA promises regulatory guidance this year

By: Brian Dolan | Mar 17, 2011        

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Brian Dolan, Editor, MobiHealthNewsAccording to a report from consulting firm Emergo Group, FDA officials said they would offer up guidance on how it plans to regulate mobile medical applications before the year is over. The report is not surprising considering the work that the mHealth Regulatory Coalition (mHRC) has done on the subject. Late last year the mHRC submitted its own guidance document for the FDA to consider as it determines how best to regulate mobile medical apps.

The question of whether the FDA would regulate the industry was never a serious one — it’s always been a matter of how.

“Manufacturers have thus far received little official guidance from the FDA regarding how the CDRH would handle mobile medical applications… According to information provided by FDA officers at the town hall, software validation will be required for mobile medical applications. Whether such devices would have to go through 510(k) or pre-market approval processes, or be ruled 510(k)-exempt—has not yet been determined, [the officials] said,” according to the Emergo report.

Of course, the FDA has cleared medical devices that connect to cellular networks via embedded chips or through connections to mobile phones. In recent years the FDA has also granted 510(k) clearances to a number of health-related software applications intended for use on smartphones, mobile phones or PDAs. Yes, the regulation of medical software on handheld devices began long ago.

The Emergo report pointed to a couple of the more well-known examples of medical apps that have received FDA clearances, and their inclusion of MobiUS’s Mobisante is a little off the mark is correct. UPDATE: Mobisante CEO Sailesh Chultani confirmed with MobiHealthNews that although the summary document for its MobiUS Ultrasound Imaging System’s 510(k), clears the probe to connect to a “host computer” and makes no mention of software on or accessed through a mobile phone, the longer 510(k) document does.

However, after a quick search of the FDA’s 510(k) clearances archive we discovered only seven eight nine ten eleven examples of mobile medical software that have achieved FDA’s greenlight over the years. (Keep sending them in!) Ignore the misleading headlines that the FDA is set to begin regulating mobile medical apps, it’s clear that the FDA began years ago:  Keep reading>>


Updated: 71 percent of oncologists say mobiles reduce errors

By: Neil Versel | Mar 17, 2011        

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Physician Interactive's Brett Miller

Brett Miller, President, Physicians Interactive Holdings’ Healthcare Professional Division

In the relatively short history of mobile healthcare, 11 years might seem like an eternity. But that’s how long mobile healthcare content provider Skyscape has been in business. Fittingly for such an established player, the Marlborough, Mass.-based company has had to reinvent itself several times to stay relevant.

“Skyscape evolved as kind of an Amazon of medical resources,” Brett Miller, president of parent company Physicians Interactive Holdings’ Healthcare Professional Division, tells MobiHealthNews. It took well-known medical texts and reference books and repackaged them in digital form for PDAs and, later, smartphones.

In 2009, Skyscape was bought by Physicians Interactive, the former drug-detailing unit of EHR vendor Allscripts Healthcare Solutions. Skyscape now accounts for about 90 percent of the Healthcare Professionals Division.

Miller, who joined the company in February 2010, says it’s fair to call Skyscape and the Healthcare Professionals Division the mobile arm of Physicians Interactive for now, but expect that to change in the future. “It probably will evolve into more than that,” Miller says. “We own some proprietary resources to help physicians with their workflow,” he explains.

And mobile is the right way to reach them, according to a survey of oncologists that Skyscape planned to release today. “Responding to a survey by Skyscape, oncologists said the use of mobile technology helps reduce medical errors and increases the amount of patients they can see during the day,” a company statement says.

Actually, less than a majority made those claims, but the results are interesting. About 33 percent of respondents said that mobile devices “create efficiencies in their weekly workflow that  allows them to increase patient volumes,” according to Skyscape. More than 71 percent Some 45 percent of the oncologists said mobile resources—including Skyscape’s drug-dosing calculator—helped them reduce medical errors. (Update: Skyscape tabulated the wrong percentage in an earlier version of their press release, which is now pushed back and will be published next week.) Keep reading>>

Roundup: Self-tracking, MyChart, SXSW, more

By: Brian Dolan | Mar 16, 2011        

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FitBit, one of the more popular self-tracking devices

Why self-tracking should be of interest to employers: “What if you could track everything you do in life? That is the idea behind self-tracking, a new method of tracking daily tasks, whether by using a health monitoring product, gauging employee productivity, or just finding out if your workers are happy,” from a report over at Inc. Magazine‘s technology site.

Smartphones and cargo containers: “Researchers with the National Center for Telemedicine and Telehealth are exploring how smart phones and cargo containers equipped with two-way video technology can link soldiers to care across long distances. Tests are underway for smart phones, and the first converted cargo container is already in use,” according to this report over at The Army Times.

University of Utah Medical Center describes their use of Epic’s MyChart iPhone app with their patients: “Anything entered into the electronic medical record resulting from an office visit or hospital stay can be accessed with the app, including test results, messages to and from a doctor or the clinic staff, a list of appointments (past and future), patient education, medication and allergy lists, immunization records, reminders for preventive care, and more,” according to this report over at Deseret News.

AutismSphere is developing a smartphone and mobile phone-based service for students with autism. “The idea for using software for autistic children is not new, but earlier efforts were largely unsuccessful. Mesibov himself was involved in one of those earlier efforts, which attempted software for personal digital assistants. That software was unsuccessful in part because of the difficulties teachers and parents had. The recent proliferation of smart phones has changed the game as the hardware has improved and users now actively seek applications for mobile devices,” according to the report over at MedCity News.

Mobile Midwife is “a system that uses cell phones to improve the delivery of health care to pregnant women and newborns in a poor agricultural region of Ghana… [that] has been operating since last fall, and parts of it may soon be replicated in India and other poor areas of the world,” according to a report over at The Portland Press Herald.

SXSW global mobile health panel coverage: “From medication reminders and mobile payments to mashing up medical devices with available hardware and leveraging broadband networks, public health workers and application developers are coming together to re-imagine health delivery in some of the poorest health-hungry nations in the world,” Jane Sarasohn-Kahn writes over at Health Populi.

QR Codes also known as 2D barcodes and mHealth. JaeSelle

Noted telecom analyst Jeff Kagan think mHealth’s “fuse is lit”. “This mobile health space is starting to get some traction, and I believe it is getting ready to explode into the marketplace. That’s the good part,” Kagan writes over at E-Commerce News.

SXSW: Four landmines mHealth needs to clear

By: Brian Dolan | Mar 16, 2011        

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Cambodian MinefieldThis week during a panel focused on mobile health apps at the South By South West (SXSW) event in Austin, Texas, the four panelists offered up a handful of “landmines” that are currently embedded in the way developers and service providers are approaching mobile health.

The session was titled: Health — Is there really an app for that? and it was moderated by Edelman’s Gigi Peterkin and included panelists John DeSouza, President and CEO of MedHelp; BJ Fogg head of the Stanford Persuasive Technology Lab; Margie Morris, clinical psychologist and senior researcher at Intel Labs; and health economist Jane Sarasohn-Kahn of Health 2.0 Advisors.

Sloppy behavior change strategies

“The one landmine that I have seen a lot is sloppy thinking around behavior change,” Fogg said. “There are lots of different types of behavior change — I think there are fifteen — and it’s very different to get people to do something one time like a health risk assessment vs. stopping something like quitting smoking vs. creating a daily habit. So, we need clearer thinking around behavior change.”

The only discussion that I’ve seen around mobile health and behavior change strategies has taken place at Fogg’s event Mobile Health at Stanford or at the events where Fogg has spoken: Connected Health Symposium, the upcoming health design conference in Boston and thanks to this panel, SXSW. I have never heard anyone argue against the point Fogg made above. Mobile health needs to better understand behavior change. No other device is as personal as the mobile phone — it’s encouraging the Fogg’s focus these days is on how to use mobiles for healthy behavior change. Keep reading>>

Epocrates founders raise $10.8 million for Doximity

By: Brian Dolan | Mar 16, 2011        

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DoximityDoximity, a new health IT company from the founders of Epocrates, secured a $10.8 million Series A venture capital investment from Emergence Capital Partners and InterWest Partners, funding further development of its secure physician network, which already counts 7,000 doctors as users of the free mobile app.

Doximity describes itself as a medical communications platform that uses social networking technologies to enable doctors to communicate securely with one another. It’s also designed to be used via smartphones. Unlike other physician social networking sites, Doximity is real-time and not anonymous. One of its core offerings is to help physicians find each other. An example of the type of search a Doximity user might make through the platform: “Psychiatrist in Tampa who speaks Spanish.”

Doximity also enables physicians to send text messages and MMS to each other via a secure network, according to the company. On this front Doximity is competing with doctors’ current primary mode of communication: the fax machine.

Doximity aims to help docs find the right medical expert for a patient, coordinate care with other healthcare professionals, and build their own medical practices. Eventually Doxmity hopes to become “the gold standard” national directory of physicians, health professionals, hospitals, nursing homes, imaging groups and labs.

Doximity’s founder and CEO is Jeff Tangney, who was formerly President and COO of Epocrates. Doximity’s founding team also includes: Dr. Elise Singer, Dr. Marc Lawrence, Shari Buck, Mark Pagura, and Al Fontes. Dr. Richard Fiedotin and Dr. Tom Lee, who co-founded Epocrates with Tangney, are advisors and contributors to Doximity, according to the company.

If Doximity’s promises of secure communication between doctors via smartphones are real, then the question is: Are doctors ready? Sure, three out of four doctors in the US have smartphones today, according to the oft-quoted figure, but are they willing to communicate in real-time, onymously? (That’s the awkward opposite of anonymously, apparently.)

Tangney and his team now have $10.8 million to find out.

Android tablets may be the new Zune, but don’t count out BlackBerry

By: Neil Versel | Mar 16, 2011        

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Neil VerselThe biggest news this week in mobile healthcare might have nothing at all do with healthcare—at least not directly. Microsoft apparently giving up on the Zune music player, admitting what everyone else has known for years, that Apple’s iPod reigns supreme in the realm of digital music.

Why is this relevant to healthcare? You may have heard some news recently about the introduction of another Apple product called the iPad 2. It’s lighter, thinner, faster and has longer battery life than its predecessor, and it boasts front and back cameras to enable live video chats — important for things like telemedicine.

The praise for the hot-selling second generation tablet has been nothing short of breathless, including within healthcare. “A faster, smarter iPad 2 helps not only the clinicians who use the product in their work environment, but it also breathes life into a growing number of health applications being developed by vendors looking to organize, store, and share medical data. In fact, vendors are quick to note that their products are iPad ready — an added selling point for their own health related products,” raved InformationWeek.

Clinicians apparently are riding this iPad wave.

Aptilon, a Montreal-based company that helps pharmaceutical and medical device makers market online to physicians, reports that 79 percent of U.S. healthcare professionals named the iPad as their tablet of choice. That’s far ahead of the 12 percent of those surveyed by Aptilon who would choose a Windows tablet and the 9 percent who would go with a Google Android-powered device. Keep reading>>