When will the FDA drop the gavel?
 Back in February we reported that the Food & Drug Administration (FDA) had just begun its conversation with the mobile health industry and that the ways in which it would regulate this emerging industry would come out of that conversation.
It’s now November and those working on wireless health are getting antsy. When will the FDA weigh-in?
For the past few months, Bradley Merrill Thompson, Partner at Epstein Becker & Green, has penned contributed articles for MobiHealthNews that outline how the FDA might regulate wireless health under its existing system.
“At a high-level, we look for two things: (1) a device with (2) a medical intended use. The first prong of the test — that there must be an actual product — means FDA doesn’t regulate, for example, medical procedures. The thing in question must be a thing, and not information or something else intangible. Software can be a medical device if it’s written on computer media, as opposed to printed on paper. The media with the code written on it is enough of a ‘thing’ for FDA to regulate,” Thomspon writes. “In the area of mobile health technology, it’s important to understand that an accessory or a component of a medical device is itself a regulated medical device. Further, the difference between an accessory and a component is who buys it. End-users buy accessories, while manufacturers buy components. Thus the exact same piece of equipment could be either an accessory or a component depending on the target purchaser.”
To get a better understanding of the FDA’s potential role in regulating wireless health, be sure to read Thompson’s article on Mobile Phones and Certain Accessories and also Thompson’s Step-by-Step Guide to Wireless Health Regulation.
Just this week the medical technology blog MedGadget wrote that the “U.S. FDA and other regulatory agencies are far behind the times that we live in, so they have no current policies to deal with the proliferation of mobile computing devices and their potential uses in medicine. Hence, none of the iPhone applications and attachments are classified as medical devices, so they are sold for nonmedical uses only.”
Of course, the AirStrip OB iPhone app has already attained FDA clearance, but what about the other iPhone apps intended for use in clinical settings? Many of them would qualify for FDA regulation under Thompson’s analysis.
It’s become a common refrain from those wireless health device makers and service providers who have already gone through FDA clearance: Soon the FDA will swoop in and regulate medical apps for smartphones.
We are beginning to wonder: Will the regulatory gavel fall in 2010?
NEXT WEEK: For all our international readers, next Thursday is Thanksgiving here in the U.S. so we will not be publishing the newsletter, but we will continue to update the MobiHealthnews website all week. If you’re looking to catch up on wireless health news, stop on by www.mobihealthnews.com. And for all those celebrating, enjoy the holiday next week!
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| iPhone adapter connects old stethoscopes
While it has been pushing antimicrobial cases for smartphones used in healthcare settings for the past few months, start-up RidRx’s device offering received a lot more attention: iStetho Adapter enables users to connect old stethoscopes to an iPhone or iPod Touch. The company also developed an iPhone app, iStethoscope Pro, and suggests that users look to iPhone apps iMurmur or iAuscultate to analyze the sounds from the stethoscope better.
Medgadget posted an important disclaimer regarding the the iStetho yesterday: “U.S. FDA and other regulatory agencies are far behind the times that we live in, so they have no current policies to deal with the proliferation of mobile computing devices and their potential uses in medicine. Hence, none of the iPhone applications and attachments are classified as medical devices, so they are sold for nonmedical uses only.”
(It’s worth noting, however, that AirStrip OB is the one iPhone application that has received FDA clearance — so there currently is one exception to the disclaimer above.)
Watch this video demo of how the iStetho Adapter works:
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Making the case for Bluetooth in healthcare
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by Michael Foley, Ph.D., executive director, Bluetooth SIG
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With 20 million devices in the marketplace today, Bluetooth technology is already the de facto wireless standard for health and fitness devices. Whether the device is a defibrillator, weight scale, heart rate belt, glucose meter or a Wii Fit Balance Board, manufacturers have been enthusiastic in choosing Bluetooth technology as their device connectivity solution.
This success hasn’t come by chance. Bluetooth technology offers advantages other wireless options, whether standard or proprietary, cannot. Key Bluetooth benefits are:
- Excellent resistance to interference
- Best in class security
- Power optimization
- A royalty-free licensing regime that gives manufacturers the confidence to use the technology without complicated IP issues
- Low cost; both as a result of the specification design and the economy of scale accruing from the production of the billions of silicon chips by multiple vendors
- Security of supply from that same range of silicon vendors
- Market presence; Bluetooth technology is the short range radio of choice in mobile phones
- Support from a community of over 12,000 member companies
Medical devices are still not perfect; they have an Achilles’ heel, which is the proprietary manner in which data is formatted. This weakness means that similar devices from different vendors cannot talk to the same application. But, the Bluetooth SIG is already working to remove this challenge. With the cooperation of the Continua Alliance and the IEEE 11073 Personal Health Devices group, the SIG has brought a Health Device Profile to market. This profile was chosen as the wireless transport by the Continua Health Alliance and is serving as the first joint step in removing the barriers of proprietary data formatting and, at the same time, bringing interoperability to the medical market.
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Gartner: Mobile health a top app for 2012
Research analyst firm Gartner put together a top ten list of mobile services for 2012 and mobile health monitoring services made the list at number five:
“Consumer mobile applications and services are no longer the prerogative of mobile carriers,” Sandy Shen, research director at Gartner stated in a company release. “The increasing consumer interest in smartphones, the participation of Internet players in the mobile space, and the emergence of application stores and cross-industry services are reducing the dominance of mobile carriers. Each player will influence how the application is delivered and experienced by consumers, who ultimately vote with their attention and spending power.”
“The ultimate competition between industry players is for control of the ‘ecosystem’ and user experience, and the owner of the ecosystem will benefit the most in terms of revenue and user loyalty,” Ms. Shen said. “We predict that most users will use no more than five mobile applications at a time and most future opportunities will come from niche market ‘killer applications’.”
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| AllOne Mobile: 5,000 texts to soldiers
AllOne Health announced that its pilot with the U.S. Army, called mCare, has facilitated more than 5,000 messages to the 100 “wounded warriors” participating in the program. The participants are U.S. veterans with traumatic brain injuries who typically need constant follow-ups and continuing medical care. The Army and AllOne plan to expand the number of participants to 10,000 wounded warriors.
Here’s an excerpt from the Government Technology article:
“Participating veterans must have phones with text messaging and picture message capabilities. However, if they don’t have a phone, one is provided for free. In addition, veterans who already have phones with these features, but do not have a data plan, can add one and are then reimbursed by AllOne Mobile.
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GE’s Vscan ultrasound device sub-$10,000
Medgadget got the inside word from GE on its newly unveiled Vscan device, which is a wireless ultrasound device that is about the size of a mobile phone. GE also recently announced that clinical trials are currently underway in hospitals in Spain and Italy. Medgadget acquired a list of some of the specifications about the device:
Vscan will cost less than $10,000; it will have about one hour of operational battery life, and will require about one hour to charge the battery; the battery will be interchangable and will include a separate charger; the device will also have software to interface with still images and videos with electronic medical records.
At TEDMED last month, The West Wireless Health Institute’s CMO Dr. Eric Topol predicted that tools like GE’s Vscan are pushing the stethoscope to extinction. Topol predicted that by 2016 physicians won’t need the stethoscope anymore.
Medgadget has much more on the device, here. Or continue on to watch a demon of the Vscan device:
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Text4Baby: High profile demo for mHealth
HIStalk interviewed Voxiva Co-Founder, Chairman and President Paul Meyer this week and the result was a sprawling conversation that covered mobile phones’ roles in healthcare today. Of course, the interview also included some discussion about the wireless health service, Text4Baby, that Voxiva and its partners have been quietly working on — interestingly, Meyer told HIStalk that the “initiative isn’t announced yet.” While it’s true that the group hasn’t publicly launched the text message-powered support service for expectant mothers, news of its imminent launch has been circulating for many months.
In June we reported on a meeting in Nashville where Meyer first mentioned the Text4Baby initiative. Text4Baby was then more officially announced at a CTIA-sponsored meeting on Capitol Hill this past July when Dr. Dan Fletcher, an adviser to the White House Office of Science and Technology, explained to the audience one example of a public-private mHealth partnership was “Text4Baby, [which] would allow for the delivery of periodic messages to expecting mothers reminding them of basic healthcare needs.” In September, which was the month Text4Baby was originally set to launch, we heard a rumor that the service would launch soon. Then HHS Secretary Kathleen Sebelius hinted at the Text4Baby service during her keynote earlier this month at the mHealth Summit in D.C.
Here’s how Meyer described the initiative to HIStalk (notice he does not mention it by name):
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ZigBee Alliance teams up with ATA
Clearly wireless technologies’ importance to the telemedicine industry is growing. Here’s more evidence: The ZigBee Alliance and the American Telemedicine Association announced an agreement today to work together to evangelize ZigBee technology’s use cases for the healthcare industry. ATA plans to promote ZigBee to a number of groups, including “traditional medicine, academic medical centers, technology and telecommunications companies, e-health, medical societies and government,” according to the organizations’ press release. The pitch includes an emphasis on the benefits that telecommunication technology provides to improve “the quality and efficiency of medical care to patients.”
“We are honored to be working with the American Telehealth Association to expand telehealth solutions for all consumers and care providers,” said Dr. Robert Heile, chairman of the ZigBee Alliance. “ATA’s members are a knowledgeable community of technology, medical device and health care industry leaders who can help us deliver greater independence, safety and improved health to everyone everywhere, every day.”
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Triage Wireless now Sotera Wireless
San Diego, California-based start-up Triage Wireless has changed its name to Sotera Wireless as part of an agreement with Inverness Medical Innovations, which markets products under the Triage brand.
Triage Wireless, now Sotera Wireless, has close ties to Qualcomm and is developing continuous, non-invasive blood pressure monitoring technology with arterial-line accuracy and without the need for frequent cuff inflations. This technology is at the core of Sotera’s monitoring platform, called ViSi Mobile, which includes a wireless, body-worn device to monitor the patient’s vital signs. The start-up is focused on the in-hospital market first, but its systems could find a market in remote patient monitoring or consumer health in the years ahead.
Perhaps interesting to note that “soter” means “savior” in Ancient Greek.
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Global health round-up: Microsoft, DataDyne
Microsoft has launched awards for mobile health solutions in Africa: “We propose to demonstrate the potential of mobile phones to enable the delivery of healthcare-related services on the African continent. We invite Africa-based researchers to apply for grants of cash to conduct one-year studies. Successful proposals will use Microsoft technologies and may also employ the capability of a mobile phone to interface with other devices, such as specialist medical hardware. A fieldwork component is strongly encouraged and the potential to increase the scale of the project (to, for example, serve large populations, address multiple diseases, or service various regions) is essential.” More
3GDoctor reports on a feature in South Africa-based ITWeb: “An optimistic piece on how Mobile Heralds Healthcare Revolution and M-health is the next big step in terms of healthcare delivery.” More
India-based Wipro has created a gateway that uses cellular (GSM) technology to collect data remotely from medical devices, including blood pressure monitors, glucose meters, pedometers, and weighing scales available with patients in rural areas of India. More
mHealth pioneer’s platform named “Most Influential Innovation”: Forbes named one of the most well-known global health innovators, Joel Selanikio, COO and Co-Founder of Washington DC-based DataDyne as the “Most Influential Innovation” among seven technology innovators for his “EpiSurveyor disease outbeak software.” More
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Shorts: CGM start-ups; Intel’s reader
CGM start-up raises $3M: Echo Therapeutics, which is developing a needle-free, non-invasive, wireless, transdermal continuous glucose monitoring system and and a system for transdermal drug delivery, raised $3 million in additional capital by selling common stock to accredited and institutional investors. More
Medtronic points to studies lauding CGM: “It’s very exciting to see the evidence unfold for Personal CGM,” said Francine Kaufman, M.D., chief medical officer and vice president, global medical, clinical and health affairs at Medtronic Diabetes. “World Diabetes Day reminds us to acknowledge favorable evidence and incorporate tools into daily practice to improve patients’ lives.” More
Tracking limb movements for diabetics: Tomorrow Options will demonstrate its WalkinSense portable patient mobility monitor, a non-invasive, wireless device that gathers and processes data of lower limb movements during walking, measuring both patient mobility patterns and plantar pressure. The system was designed for diabetics. More
Intel digital reading device: ZDnet’s Dana Blankenhorn has a worthwhile analysis of Intel’s recently unveiled portable reading device for the dyslexic, blind and others who need help reading: “The Intel Digital Health Group is as serious as a heart attack, and the Intel Reader is part of it. The device is actually a specialized computer, combining a camera, optical character recognition, and a voice chip.” More
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| What’s Happening |
Mobile Healthcare Industry Summit
Dec. 1-2,
London, UK
The ONLY Event For Best Practice and Innovation In Global Wireless and Healthcare Convergence
With a special keynote delivery from Vittorio Collao, CEO, Vodafone Group we bring you the lead pioneers in wireless and healthcare convergence and best practice. Expect two days of 50:50 representation from the communications and healthcare sectors working towards services innovation and partnership – with Continua Health Alliance, GSMA, NHS, M Health Alliance, Vodafone, Orange, Verizon, Microsoft, Bluetooth Special Interest Group and more.
Register here
Mobile Forum: Mobile Health
Dec. 9, 2009
Menio Park, CA
Mobile Health is an increasingly hot topic – driven by better devices, better networks, and a national imperative to curb healthcare costs. Improved short-range protocols, sensors, lower power consumption, and mobile gateways, affordable solutions are within reach of entrepreneurs at a time when health costs are getting national attention. Meanwhile, insurance companies are spending money to lower the costs of care, and the mobile industry is eager to stake its role in this emerging ecosystem. This is a great time to launch solutions that can lower costs and keep people healthier.
Register here
2010 Silvers Summit
Jan. 9,
2010 at
International
CES, Las Vegas, NV
Boomers are re-booting life’s rules on how we age. Whether they’re listening to MP3’s on the treadmill, playing brain games on a netbook, or monitoring their parent’s home safety or texting the grandkids, this generation is maximizing their digital life. Hear from the companies, organizations and thought leaders applying technology to improve quality of life and independent living of adults over the age of 45 and for their elderly parents. Experts weigh in on lifestyle trends, product design, caregiving and reminder technologies and more.
Register here
International CTIA Wireless 2010
March 23-25,
2010 at the Las Vegas Convention Center
The International CTIA WIRELESS® show represents a $1 trillion global marketplace that brings together wireless and converged communications, wireless broadband, applications, mobile web and data.
For 25 years, International CTIA WIRELESS® has been THE premier marketplace for all things wireless. Don’t miss 2010-guaranteed to be another crucial and groundbreaking event for the industry. Join us for the next era of Mobile Life!
Register here
CIO Healthcare Summit
May 9-12, Scottsdale, AZ
The CIO Healthcare Summit is a gathering for C-suite executives and industry thought leaders to discuss IT challenges currently facing the health care industry, including improving patient care, controlling costs and meeting government regulations.
Register here
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