By any other name…
 Qualcomm and Verizon Wireless have officially named their machine-to-machine joint venture, nPhase, after the M2M company Qualcomm acquired a few years ago. While the new JV will certainly include healthcare applications, it also has telematics, smart grids and other key M2M markets within its focus. nPhase could become a key driver of Qualcomm’s healthcare initiatives.
While on the subject of Verizon Wireless, the carrier recently certified Panasonic’s Toughbook H1 tablet to run on its network. The H1 was designed — with a few pointers from Intel — to meet the needs of clinicians looking for a mobile device that fits their workflow. It’s a definite upgrade from a COW, which, we hear are sometimes referred to as “dolphins.” To compete, maybe Panasonic needs to pick an animal branding for the H1? If you have any suggestions, we can send them along.
The Mobihealthnews team recently had to brainstorm some names of its own, while putting together our first wireless healthcare event: Mobihealthnews Presents: Everywhere Healthcare. Rhyming has always been our strong suit. The caveat is, of course, that wireless healthcare is everywhere you can get a wireless signal. The event is co-located at CTIA Wireless IT & Entertainment in San Diego on October 8th. Our speaker line-up includes representatives from the Continua Health Alliance, Qualcomm, the American Telemedicine Association, MedApps, Dossia and AllOne Mobile among many others. We are also happy to count the Wireless Life-Sciences Alliance, the West Wireless Health Institute and other groups among our strategic partners for the event. Everywhere Healthcare is open to all CTIA attendees, so be sure to let us know if you’ll be stopping by!
There are a number of great events coming up in the next two months, so be sure to mark your calendars — September: Medical Device Connectivity Conference & Exhibition in Boston; Duke University’s Medical Innovation and Strategies Conference in Durham, North Carolina; The ATA’s Mid-Year Meeting in Palm Springs. October: The Health 2.0 User-Generated Healthcare event in San Francisco; Mobihealthnews Presents: Everywhere Healthcare in San Diego; Partner’s 6th Annual Connected Health Symposium in Boston; and, of course, TEDMED 2009 in San Diego… just to name a few.
Mobihealthnews will be at most of the events listed above and we’ll be looking to meet innovative wireless healthcare companies with news and perspectives to share. If you’d like to set-up a meeting, send me a note. If you want to discuss sponsoring our event coverage, be sure to ping my colleague Joe Maillie.
Enjoy these last few weeks of summer, conference season is soon upon us.
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| Interview: American Telemedicine Association
“The single fastest growing medical device we have in this country is probably the iPhone,” Jon Linkous, CEO of the American Telemedicine Association told Mobihealthnews. “I have discussions about the iPhone every single day.”
Linkous also explained how the telemedicine industry has grown from “white labeled” (literally) corporate video conferencing solutions to the rapidly growing wireless health market we know today. The interview touched on wireless health’s place in the national healthcare reform discussions, physicians’ fear of telemedicine, generational shifts and the types of start-ups knocking on ATA’s door. Read on below for more from the interview with Jon Linkous, CEO of the ATA.
(AND: If you want to hear more from Linkous and other wireless health thought leaders, join us at the Everywhere Healthcare event at CTIA Wireless & IT in San Diego this October.)
Mobihealthnews: What is the American Telemedicine Association (ATA)?
Linkous: The ATA was created in 1993 by a group of doctors who were using video conferencing links between larger health centers and rural clinics. Both the field of telemedicine and the ATA has taken off from there. Today, we have a broad and eclectic membership so we like to say we are part trade association and part professional association. That means we have clinicians, physicians, nurses as well as hospitals, institutions, government organizations, corporations, providers. That includes any one from Verizon, Intel, UnitedHealth Group to Qualcomm plus a lot of medical device groups, too. It’s intentionally broad-focused — both our membership and interests. We do a lot of education work, which includes our annual conference, advocacy in Washington and elsewhere. We also have special interest groups, about 15 different member groups in various areas that provide networking, education and we are starting to create practice guidelines related to healthcare.
Telemedicine includes a number of different enabling technologies, including landline telephony, broadband wireline, wireless networking and others. Can you briefly take us through how those technologies have evolved since ATA’s founding, and how that has changed the industry?
It’s been an amazing trip. When we started out most of telemedicine was a large video conferencing box that was primarily used for corporate video conferencing that [telemedicine groups] would paint white, literally, they’d paint it white and put a red cross on it and call it medical equipment. It was large, cumbersome, very expensive and required broadband hookups, which were also not cheap. The [connectivity requirements back then were] multiple T1 lines or ISDN just to get this to work. Because of that, the industry was largely government grant focused and there were some other applications, but not too many. From there these systems got smaller and more efficient but they were still focused on video conferencing. Continue >>
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CardioMEMS gets $22.1M in venture capital
Wireless sensing and communications developer CardioMEMS just announced that it had completed a $22.1 million round of financing. The company said that the additional funds will bankroll its heart failure clinical trial, which was initiated in September of 2007 and is currently taking place in more than 65 heart centers across the U.S.
CardioMEMS first announced its heart failure pressure management system in 2006: The system includes a wireless sensor that is implanted into the patient’s pulmonary artery. The sensor can then measure pulmonary artery pressure and display the data to patients at home. The pressure data is also transmitted to a secure database the physicians and the patients can review on CardioMEMS proprietary website. The company plans to seek FDA approval of its CHAMPION heart failure pressure measurement system in 2010.
Dan Bauer, CardioMEMS CFO stated, “We are pleased with the continued support of Arcapita Ventures, Boston Millennium, Foundation Medical and our other existing investors. We look forward to the successful completion of the CHAMPION trial as well as pursuing other opportunities where our technology can be beneficial.”
For more on CardioMEMS, check out the company’s recent press release.
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Interview: Layar, augmented reality and mHealth
If your smartphone has a compass built-in, a camera and GPS, then it may soon offer “augmented reality” applications, which overlay information onto the phone’s screen while the camera is being pointed at a particular object or location. A Wikipedia article may pop up if the phone is pointed at the Washington Monument. A link to a person’s Facebook page may appear when the phone’s camera is pointed at a friend. These are the more talked about applications coming out of this mobile-powered, emerging industry known as “AR”.
Augmented Reality was recently pegged as the next big trend to hype in the tech industry. The publication that made the claim, ReadWriteWeb, is likely right, but their article closed with a sobering quote from the chairman of the AR Consortium, Robert Rice, which helps to put the emerging industry in perspective:
“Don’t be misguided by the gimmicky marketing applications now. Look ahead, and pay attention to what the visionaries are talking about right now,” Rice said. “AR has long-term implications for smart cities, green tech, education, entertainment, and global industry. This is serious business, but it has to be done right.”
We wondered if healthcare should be added to that list, so Mobihealthnews recently caught up with one start-up, called Layar, which has led the pack of AR developers with its platform for Google’s Android-powered mobile phones. Layar’s co-founder and director of distribution and marketing, Maarten Lens-FitzGerald, sees a lot of opportunity for healthcare service providers to leverage his company’s platform beyond the applications that exist today.
Mobihealthnews: Could you describe what Layar is and what the platform enables?
Lens-Fitzgerald: The unique thing about Layar is that it combines digital information with the real world around you. As you look through your phone’s camera, wherever the phone is pointed at, Layar overlays information on the screen that shows information about that location. Layar is a worldwide open platform that allows anyone who wants to make a “Layar” to do that. For example, if McDonald’s wants to create a Layar and display all of its restaurants’ locations, it can do that and include what menus they have at each or what opening times they have. This Layar can then be viewed in our Layar Browser, which is just like a Web browser on a mobile. It does not show Web pages, however, but specific Layars. It’s a tool that lets you discover your surroundings. Continue >>
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| Step-by-step: FDA wireless health regulation
Last month I outlined the triggers that could cause an ordinary mobile phone to become an FDA-regulated medical mobile phone. This month, in the second of six planned articles, I will outline the FDA requirements that would apply to a mobile phone that crosses that line.
To summarize the July 13 article on “FDA may regulate certain mobile phones, accessories”, a mobile phone could become a regulated medical device if the manufacturer, through its words and deeds, conveys an intention that the phone be used in medical applications. I also pointed out that medical devices come in at least three different flavors: (1) standalone medical devices, (2) accessories and (3) components to such devices.
Premarket clearance or approval
In contrast to components that are simply sold to another manufacturer, standalone medical devices and accessories sold to end users may require some form of premarket clearance or approval. Once you know you have an FDA-regulated device or accessory, here’s how you figure that out, following a five-step process.
Step one. Figure out the most appropriate classification for your product.
There is a bit of both art and science to this. FDA has published about 1700 classification regulations. Each of those regulations has a description or “identification” of the types of devices covered by that regulation. FDA has a searchable database of these regulations accessible through their website.
Some articles of hardware and software are so important that FDA has separately classified them, and you can find them directly through searching. The regulations are organized by clinical application so all of the orthopedic devices, for example, are in one part of the regulations. So you might get lucky and find one that directly describes your product. A quick search of the regulations revealed that the word “computer” appears in 225 regulations, “software” in 431 and “network” in 43. There is, for example, a classification for remote medication management systems in 21 CFR 880.6315.
But if you can’t find one that directly describes your product, perhaps it’s because FDA considers your product to be merely an accessory to a “parent” device. I’ll give you an example. Last month FDA cleared an updated version of the Polytel glucose meter accessory, which is a small module that plugs into the port of a glucose meter, receives data from the meter and transfers it wirelessly to an Internet capable communication device like a cell phone or an APT. In clearing the device, FDA agreed with its classification in 21 CFR 862.1345, which covers all glucose test systems, including the “parent” glucose meters. Continue >>
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Successful mHealth apps are already here
Forget about remote monitoring, wearable sensors, NFC/RFID, smartphones, software apps, GPS, mEHR’s, video messaging, 3G video calling and SMS. These are part of a wave that is without a doubt advancing, but the evidence of successful mHealth applications can already be found throughout the healthcare system:
Urgent Care: For over a decade emergency medical services around the world have reported that increasing proportions of their calls originate from mobiles and evidence shows that patients are increasingly feeling confident to make those calls via mobile in preference to available landlines. Mobile emergency calls enable several new advantages through combinations of device, network and service technologies including location, caller ID, always best connected, call waiting messages, the ability to deliver real-time advice on first aid/medical treatments, more efficient deployment of response personnel/equipment and so on.
General Health Benefits: Imagine how the health of the worlds population has been improved because we have mobiles: the rushing on our roads that used to be excusable because it was impossible/very difficult to call/text ahead to say you’ll be five minutes late, the reassurances that we now have knowing that our daughter/son is safe on a night out without having to wait until they arrive back in the door, new found abilities to offer an ear to the lonely or house bound because we now have anywhere anytime access.
Preventative Care: Mobile is ideally suited to serve preventable diseases and help manage chronic disease by motivating individuals (through the use of highly personalized multimedia content) to make healthier lifestyle choices without the burden of time/effort or the indiscretion that might be associated with the use of another/differentiated electronic device. Continue >>
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CIMIT awards diabetes iPhone app $100,000
Matthew Connor, a rising junior at Princeton University received a $100,000 grant from Center for Integration of Medicine and Innovative Technology (CIMIT) to build a more in-depth online portal for his diabetes management iPhone app, Islet, which Connor and his brother launched last September. Islet enables diabetics to record what and how much they eat, their insulin injections, blood sugar readings and activity level. Islet also graphs these data to help the users make more informed health decisions. Connor estimates that the app has “several thousand regular users worldwide.”
“For instance, maybe you notice that your blood glucose tends to spike in the morning,” Connor said. “If you keep good records, you might realize that this happens only after you drink a glass of orange juice at breakfast. Without good records, you may never know what’s causing your problem. But if you collect and organize the data correctly, it becomes much easier to analyze what you’re doing wrong and what you’re doing right.”
With the new funding from CIMIT, Islet will expand to feed the data from the phones to a remote online database so the users, caregivers or their doctors can access the records for analysis. Connor also hopes the data can be used by medical researchers: The iAbetics system will include tools to allow access to researchers while protecting the patients’ privacy.
“There have been lots of attempts to use technology for diabetes monitoring, such as using PDAs and other devices,” said Ronald Newbower, the chief technology officer for CIMIT. “But none of our reviewers for the prize had seen anything that addressed the problem with such a thorough and elegant solution.”
Read the full article over at Princeton University’s website here.
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Epocrates Survey: iPhone, Palm PDAs popular
Epocrates’ fourth annual Future Physicians of America survey polled more than 1,000 medical students about their technology preferences and habits. Epocrates found that nearly 90 percent of medical students view information available through mobile or online drug and disease references, like Epocrates’ own offerings, as “highly credible.” Epocrates found that students are four times more likely to consult a mobile reference for a clinical question than ask their own attending physician. One of the more interesting charts from Epocrates survey breaks down the type of smartphones these medical students use: Continue >>
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Shorts: Band-Aid-like patches with microneedles
Band-Aid-like painless patch with “microneedles”: Researchers have designed Band-Aid-like “painless” patches that they hope will one day replace the procedure for getting a shot. The patches are lined with tiny “microneedles” that the researchers believe could change how we manage diabetes as well as a number of other diseases. The patches are supposedly “safer, more effective and less painful,” according to the developers. More
Health care and wireless can drive broadband adoption: During an FCC hearing on broadband adoption, Susannah Fox, associate director for digital strategy at the Pew Internet and American Life Project, said 63 percent of Americans have home broadband service, which is a significant increase over 2008. Pew’s data shows that one key point broadband users value most is the ability to share information with health care providers. About 80 percent of users have used broadband to find health care information online, Fox said. Making it “the de facto second opinion,” she explained. More
Continue >>
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Shorts: Glucose Buddy app clocks 400,000 logs
Diabetes app usage metrics: MYLEstone Health, developer of the Glucose Buddy iPhone app, has added a real-time tracking feature to its application for diabetes management. The service has clocked almost 400,000 user logs in the past 100 days. MYLEstone announced earlier this year that it had inked a deal with Roche Diagnostics’ Accu-Chek to add its educational program to the Glucose Buddy diabetes management app. More
Telemedicine and e-Health tackles Twitter in healthcare trend: “One way to look at Twitter is as a method of mass communication,” Joseph C. Kvedar, MD, Director of the Center for Connected Health (Partners Healthcare System, Boston, MA), told the publication. Twitter is real-time and was designed for mobility, Kvedar explained. It allows people to “text 30 people or 50 or 100 people, whatever the number is who are following you.” More (.pdf)
J&J’s SMS-enhanced BabyCenter: This Mobile Marketer case study from June examined Johnson & Johnson’s BabyCenter service, which seems to offer some of the same information as the White House/Voxiva/CDC’s upcoming Text4Baby campaign. ”Subscribers receive weekly texts chock full of pregnancy advice. Once the baby arrives, the Parenting Tips service sends new parents helpful parenting tips twice a week till three months.” More
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Smartphone sales to trump PC sales in 2011
It’s a common and very relevant pushback for wireless health: Not everyone has a smartphone. While there are plenty of solutions that do not require a smartphone, clearly health management tools are far richer when a smartphone platform is in play. RBC analyst Mike Abramsky estimates that by the end of 2011 — just two years from now — worldwide smartphone sales will pass worldwide PC sales. The two figures intersect when PCs and smartphones are both shipping about 400 million units each year. Business Insider put together a chart that tracks this trend: Continue >>
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3M unveils $500 Bluetooth stethoscope
This week 3M unveiled a stethoscope with a built-in Bluetooth radio that aims to enable physicians to detect heart murmurs and other afflictions by sending the data recorded by the device, sending it to a PC and amplifying the sound. The device is known as the Littmann 3200.
3M’s previous attempts to move sound data from electronic stethoscope to computers used infrared technology to transmit the sounds, but, according to MedCity News, those devices were considered “clunky.” 3M announced plans to phase out that series of electronic stethoscopes.
The new Bluetooth-enabled device records and stores heart, lung and other body sounds while reducing ambient noise. The Bluetooth capabilities are paired with computer software that uses a series of algorithms to analyze the sounds. Continue >>
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The Inaugural Medical Device Connectivity Conference & Exhibition
September 10-11, Boston
This innovative conference and exhibition focuses on the integration of medical devices and information systems. The conference will feature in-depth coverage of strategy and implementation as well as legal/regulatory issues. Keynote speakers include: Tim Gee, Medical Connectivity Consulting and Julian Goldman, MD, Partners HealthCare Biomedical Engineering.
Register here
First annual Medical Innovation and Strategies Conference: The Future of Healthcare
Sept. 23, Duke University
The conference, which is hosted by Gopal Chopra: MD, FRACS, MBA, Adjunct Associate Professor at the Fuqua School of Business and Kevin Schulman: MD, MBA, Director of Health Sector Management and Associate Director, Duke Clinical Research Institute, will focus primarily on ‘Wireless and Consumer Healthcare’ and will address the following topics:
1. Future impact of wireless technology on the healthcare industry;
2. Understanding the future trends of consumer healthcare; and
3. Expert panel discussions on business models and innovation solutions.
Register here
ATA Mid-Year Meeting
Sept. 24-25, Palm Springs
The Third Annual ATA Mid-Year meeting is one great meeting combining two great tracks & showcasing the latest in products and services:
Track I:
Cutting Edge and Off-The-Shelf Technology: Making the Right Decisions
Track II:
4th Annual Pediatric Telehealth Colloquium
Register here
MobiHealthNews PRESENTS:
Everywhere Healthcare
October 8, San Diego
With today’s wireless networks, the doctor is always in. While connecting patients to caregivers has never been easier, the search for the right business models for wireless health devices and services has just begun.
Don’t miss your appointment at the MobiHealthNews Presents: Everywhere Healthcare event during International CTIA WIRELESS I.T. & Entertainment 2009!
OPEN TO ALL REGISTERED ATTENDEES! There is NO separate registration fee for this event and it is included in ALL registration packages. Please see registration form for details.
Register here
CTIA WIRELESS I.T. & Entertainment 2009
October 6-9, San Diego
No matter what your business is – healthcare, entertainment, fleet management or financial planning – wireless can transform how you do business. International CTIA WIRELESS I.T. & Entertainment brings this possibility to life. With a focus on applications, network architecture and technologies such as LBS, machine-to-machine and WiMAX (just to name a few), this international event brings a community of users, carriers, developers and manufacturers together to generate dialogue, share ideas and debate the economics of MOBILE BUSINESS.
Register here
Health 2.0
October 6-7, San Francisco
With nearly a hundred speakers and plenty of new healthcare demos and technologies on display on stage and in the exhibit hall, you’ll get a sweeping overview of the ways that information technology and the web are changing healthcare. We’ll be looking at the "traditional" Health 2.0 areas like vertical search, online social networks and tools for consumers. But the conference will also be focusing on how new technologies are connecting patients and clinicians, and examining the impact of Health 2.0 technologies on patients lives.
Register here
6th annual Connected Health Symposium
October 21-22, Boston
Up from Crisis: Overhauling Healthcare Information, Payment and Delivery in Extraordinary Times
hosted by the Center for Connected Health at Partners HealthCare
Healthcare will have its renaissance when it moves beyond the hospital and clinic and into the day-to-day lives of patients and consumers. The Connected Health Symposium asks how information technology — cell phones, computers, the Internet and other tools — can help people manage chronic conditions, maintain health and wellness, and age with independence.
Use invitation code mobihealth to receive a $100 discount!
Register here
TEDMED 2009
October 27-30,
San Diego
The fifth in a series created by Marc Hodosh and Richard Saul Wurman, TEDMED celebrates conversations that demonstrate the intersection and connections between all things medical and healthcare related: from personal health to public health, devices to design and Hollywood to the hospital. Together, this encompasses more than twenty percent of our GNP in America while touching everyone’s life around the globe.
Register here
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