2009 State Of The Industry

WIRELESS HEALTH:STATE OF THE INDUSTRY2009 Year End Report December 16, 2009

TABLE OF CONTENTS

Publisher’s Note and Editor’s Letter 1

Industry Metrics: Wireless Health by the Numbers 2

Carriers Take the Lead on Wireless Health 7

Care Providers Push Pilots, Look for Results 11

Alliances and Institutes Accelerate Time to Market 14

Reimbursement Rises and Falls 18

Consumer Health: The Answer to “Who Pays?” 20

2009 Wireless Health Venture Capital 23

2009 Wireless Health Deals 25

A Step-By-Step How-to for Wireless Health Regulation 32

The Year in Conclusion 35

Dear reader,

As 2009, the first year of publishing for MobiHealthNews draws to a close, our team has been busy revisiting the top stories, deals, interviews and event coverage from the past 12 months. After writing more than 700 posts on the MobiHealthNews site, publishing 45 newsletters, attending and covering countless industry events and reading well over 2000 comments from our readers, we would like to present the MobiHealthNews' Wireless Health State of the Industry Year End Report. We would like to thank our site's premier sponsors: MedApps, West Wireless Health Institute and AllOne Health for supporting our efforts. We would also like to thank our publica-tion's many outside contributors whose perspective has added experience and depth to our industry coverage. While this report pulls from some of their work, I would like to point out that any errors, misconceptions or wayward commentary rest squarely on the shoulders of our editor, Brian Dolan.

Thank you for being an active member of the MobiHealthNews community. We look forward to serving you in the New Year.

Sincerely,Joe MailliePublisher, Co-FounderMobiHealthNews

Dear Reader,

As the break out year for wireless health comes to a close, so too does MobiHealthNews' first year of publishing. Please accept this report as our holiday gift to you. Feel free to re-gift it to colleagues, friends and family. For those scrappy wireless health startups reading, this may be an opportunity to approach that wealthy uncle or aunt you had hoped would come on as an Angel investor—N.B. this report contains nearly all of the wireless health market metrics publicly released this past year as well as a round-up of other startups that received funding in '09. The quarter-by-quarter deals charts also read like an industry timeline that chronicles much of the higher-level activity that took place throughout 2009.

We hope that the recaps and summaries contained herein provide a snapshot of much of the activities that accelerated the wireless health industry these past 12 months. By the looks of it, 2010 should see even more action for wireless health. We look forward to serving you in the New Year.

Many thanks,Brian DolanEditor & Co-FounderMobiHealthNews

Publisher’s Note

State of the Industry Page 1

Letter from the Editor

Numbers can be helpful. While industry metrics alone cannot propel an emerging market forward, they can serve as inspiration to make a change. Many of the numbers pegged in this section point to opportunity. Here is the summation and aggregation of a year's worth of indus-try metrics that have shaped and prodded wireless health strategy in 2009.

Sizing up wireless health's market opportunity

The current wireless home health market is $304 million, according to CTIA, the Wireless Asso-ciation. Citing Parks Associates research, CTIA stated that the market is expected to grow to $4.4 billion in 2013, with estimated annual growth rates of 96 percent in 2010, 126 percent in 2011, 95 percent in 2012, and 68 percent in 2013.

ABI Research estimates that the market for wearable wireless sensors is set to grow to more than 400 million devices by 2014. Of course health and fitness sensors aren't the only use case for wearable sensors but they will likely dominate that market. ON World's research views the wire-less sensor market through a different lens: While it does not estimate the market for “wearable” wireless sensors, it believes wireless sensors in general will reach a global market value of $6 billion by 2012. That estimate would include wireless sensors installed at home or in managed care facilities: Certainly a key technology group for home health.

ABI Research also estimates that revenue from worldwide sales of WiFi-enabled healthcare products, a specific sub category of wireless health that probably includes medical devices inside care facilities, will reach nearly $5 billion in 2014.

Forgetting the specific technologies for a minute: What about a market size for home health monitoring of chronic diseases overall? Berg Insight pegs that figure at $11 billion last year for the US and Europe. That market is growing at 10 percent per year, the firm claims, and some 300 million people in Europe and the US have at least one chronic disease that may benefit from home health monitoring. Berg believes that about 25 percent of that population would benefit from existing home monitoring solutions currently available, while some 50 percent would benefit from integrating or connecting existing medical devices with their mobile phones.

No matter how you slice it, the market for wireless health is ripe and growing.

Consumer demand

Some 78 percent of the US is interested in mobile health solutions, according to a survey conducted by CTIA and Harris Interactive. About 15 percent of the US is extremely or very inter-ested in learning more about mobile health solutions, according to the survey. Interestingly, 19 percent of respondents said they would upgrade their current mobile phone plan to get access to wireless health services, while about 11 percent said they would even switch carriers to get access. Why were they so eager? About 40 percent said mobile health would supplement the medical care they receive from their doctor; 23 percent believe mobile health services could

Industry Metrics: Wireless Health By the Numbers


replace doctor visits altogether. More than half of respondents said mobile health would benefit rural populations the most; just under half of respondents believed people with chronic condi-tions would benefit the most; 41 percent said that retired and or Medicare patients would benefit the most from mobile health. Finally, 38 percent said caregivers would gain the most from mobile health services.

PricewaterhouseCoopers conducted a similar survey that found 73 percent of consumers would use biometric electronic remote monitoring services to track their chronic condition or vital signs. The figure closely mirrors the near three-quarters of the US population interested in mobile health.

Saying and doing are two separate things: According to a survey conducted by the National Coun-cil on Aging: One in four people with chronic conditions are delaying care. The percentage is much higher for Baby Boomer women (39 percent) and Latinos (43 percent.) Perhaps easier-to-use and more productive tools like some mobile health solutions could help encourage those with chronic conditions to take control of their own health sooner.

Expected consumer demand is driving wireless health uptake in managed care facilities: A survey conducted by the Mathers LifeWays Institute on Aging found that senior living community administrators expect that smart home and wireless health offerings will attract residents to their communities. As a result smart home technologies are expected to increase their penetra-tion from 8 percent of senior communities today to 39 percent come 2013.

Overburdened healthcare system

While the aggregate influx of connected health devices and monitoring services could potentially inject a fire hose of new data into an already overtaxed healthcare system, many wireless health tools can help care providers do their job more efficiently and stretch their reach more comfort-ably beyond their current workload. The numbers indicate that care providers as a group are shrinking while the number of sick and elderly Americans is increasing. Wireless health can play a role to mitigate these alarming trends.

At the beginning of 2009 during the height of the economic downturn, 71 percent of hospitals said that budget allocations for IT were expected to be smaller in 2009 than in 2008, according to a study commissioned by NCR. Because of the economic downturn some 36 percent of hospi-tals said they were being more cautious about IT spending, while 19 percent said they had already delayed spending on certain IT purchases. A full 16 percent delayed all non-essential IT project funding as of February.

As IT budgets shrank, the specter of a physician and nurse shortage loomed: The number of US medical school students who choose primary care has dropped almost 52 percent since 1997, according to the American Academy of Family Physicians (AAFP). The group predicts a shortage of 40,000 family physicians by 2020. The US currently has about 100,000 family physicians, but it



will need about 140,000 in ten years. Only half the number of physicians needed are entering the field today.

The shortage of nurses is already taking a toll on those in wards today: Nurses report the short-age impacts their day-to-day job, according to a study conducted by Epocrates. About 46 percent of nurses say the shortage decreases the amount of time they can spend with their patients. About 42 percent say it increases their responsibilities and about 37 percent say it increases their patient load.

To compound the problem, Americans as a group are getting older. Today, about 12 percent of the US is 65 years old or older, but by 2030 about 20 percent of the US population will be 65 or older. In 2005 the 78 million Americans 65 years old or older accounted for $2 trillion in total health expenditures. The 78 million Baby Boomers, who were born between 1946 and 1964, will begin turning 65 in 2011. The other group that could add to the strain on the system is the 47 million uninsured Americans.

Aging aside, the US population as a whole is not fit. The CDC said that the average American is about 23 pounds overweight and consumers eat about 250 more calories a day than the average American did two or three decades ago.

According to the West Wireless Health Institute 5 million Americans are affected by Alzheimers; 20 million are affected by asthma; 3 million are affected by breast cancer; 10 million are affected by COPD; 19 million are affected by depression; 21 million are affected by diabetes; 5 million are affected by heart failure; 74 million are affected by hypertension; 80 million are affected by obesity; 15 million are affected by sleep disorders.

Our overburdened healthcare system cannot help them all through the old methods, but wire-less remote monitoring tools could help prevent and/or manage these conditions and others. There are many factors that lead to disease, but up to 40 percent of all chronic conditions are attributable to our behavior. Wireless health solutions can monitor, analyze, encourage and ultimately change behavior.

The tools are at hand

For many access to wireless health solutions is a given: Close to 90 percent of the US population, about 276 million Americans, already has a mobile phone. During the first half of the year more than 740 billion text messages were transmitted in the US. Text messaging is one of the simplest channels to deliver public health messages like the White House plans to do with its Text4Baby program for low income, expectant mothers.

The Center for Connected Health estimates that there is about 20 or 30 percent of the popula-tion where text message reminders will be very powerful.



Beyond text messaging, close to 19 percent of Americans now have smartphones. By one estimate there are about 5,000 health and medical applications currently available in the market for smartphone users.

Smartphone users may include a number of Medicaid patients: According to one “unofficial” study referenced at a wireless health industry event this year, five out of seven Medicaid patients in New York and New Jersey use smartphones.

Of course, healthcare providers are also adopting mobile phones: Manhattan Research found that 64 percent of physicians use a smartphone today. That's 20 percent more physicians than in 2008. By 2013, 81 percent of physicians will use smartphones, the firm predicts.

Healthcare providers have found that not all their patients are mobile phone or technologically savvy, however: About 33 percent of the people the Center for Connected Health works with in their wireless health pilots need a phone call to have someone walk them through how to use wireless devices.

The tools are largely available and in the market. The key is to let the public know that these services are available, and then, of course, be sure to support the offerings with adequate customer service.

Estimates for cost savings

Verizon Wireless recently estimated that mobile broadband solutions improved U.S. health care productivity at a savings of almost $6.9 billion. That figure is expected to increase to $27.2 billion by 2016. And it's not just the carriers predicting big numbers: According to one survey conducted by Cambridge Consultants, 75 percent of healthcare providers, patients, payers and technology enablers believe that connected health preventative services could cut healthcare expenses by 40 percent.

The Center for Connected Health sees two key drivers for connected health: Employers want to keep their health insurance costs low by keeping employees healthy; Insurers want to keep their costs low by ensuring care providers manage costs.

As employers explore ways to help keep their employees in shape and manage their chronic conditions, wireless health service providers need to be there with solutions that have demon-strated efficacy.

Insurers are beginning to increase capitation in order to put pressure on care providers to keep costs low. The Center for Connected Health noted that its parents company, Partners Healthcare has Blue Cross Blue Shield of Massachusetts breathing down its neck to make sure they are man-aging costs. Capitation is where the insurance provider pays care providers a flat rate for a year to care for patients and the care provider then has to do its best to control costs within that



context. Partners expects that in the next three years close to 50 percent of its revenue will be capitated. That's motivation to keep patients healthy and prevent readmissions by equipping patients with the tools that help them to better manage their own health.

At least 125 million Americans are living with one or more chronic diseases. An individual living with one chronic disease costs the US healthcare system $6,032 a year on average, according to Johns Hopkins School of Public Health. The total costs of chronic diseases in the US healthcare system today top $1.4 trillion.

If a wireless health solution can help take a bite out of these figures, there is a business case for it.



“We took a run at this five years ago and it fizzled out pretty quickly,” explained Rob Mesirow, Vice President of CTIA, the international association for the wireless industry. “Quite frankly, it just wasn’t the time, the stars weren’t aligned, wireless data networks weren’t robust enough and medical data wasn’t there. Now, the next generation of doctors, who are more comfortable with health IT technology, along with stronger mandates from the federal level and robust carrier networks are coming together,” Mesirow told MobiHealthNews during an interview this past spring. “Everyone agrees that the healthcare industry is inefficient — and that’s putting it lightly.... When I specifically asked the carriers which verticals should we be focusing on, carriers have unanimously said that healthcare is one we should go for.”

Carrier involvement starts with M2M

One way that U.S. carriers will enable the wireless health market is via machine-to-machine busi-ness units and joint ventures, which aim to support connectivity for devices other than tradi-tional mobile phones. Earlier this year Verizon Wireless announced a machine-to-machine (M2M) joint venture with Qualcomm, called nPhase, which among other devices—will support wireless remote monitoring company, CardioNet's connectivity. Similarly, AT&T opened a device certification lab that aims to accelerate the entry of “netbooks, eReaders, portable navigation devices, utility products, and healthcare-related tracking devices” into the market. Shortly after the nPhase and AT&T lab announcements, Sprint inked a multi-year agreement with M2M com-pany DataSmart to help embedded device makers bring their products to market sooner. Sprint cited the demand for sophisticated M2M applications, including "the rapid growth in M2M healthcare."

Amazon's eBook reader, the Kindle has long been referenced as a model that the wireless health industry should emulate in terms of working with wireless carriers: “Maybe it’s a little overused at this point, but the Kindle represents a different model. It’s not carrier-based. It’s not subscription-based. It’s one example of the kind of creative business models that are coming out of the wireless industry,” Mesirow said. Because of devices like the Kindle and the opportunity for wireless health devices, Harbor Research predicted this past year that M2M device shipments might top 430 million units by 2013.

Verizon CEO Ivan Seidenberg believes that M2M device uptake is set to explode in the U.S. While we are approaching a 90 percent penetration rate in the U.S. for the number of Americans using mobile phones, the opportunity to reach 500 percent penetration is possible thanks to embed-ded devices and machine-to-machine (M2M) services. Seidenberg specifically pointed to connected medical devices like a wireless-enabled glucose monitor as an example of an embed-ded device that could push the industry to 500 percent penetration.

Does wireless health need a LifeComm anymore?

“MVNOs seem to pop up for anything these days,” Mesirow told MobiHealthNews. “So a health-care MVNO? Sure, why not? But I think all of the carriers are interested in offering wireless health

Carriers Take the Lead on Wireless Health


services over their networks.”

Back in 2005 Qualcomm began to publicly discuss plans to launch LifeComm, a mobile phone service with wireless health applications and devices at its core, but back then specialized mobile phones services, also called mobile virtual network operators (MVNOs) were all the rage: ESPN Mobile, Disney Mobile and AMP'd Mobile were among the MVNOs that eventually made it to market. These sports and entertainment focused services quickly lost steam and mostly disbanded within a year. LifeComm never launched officially, but Qualcomm worked on the initiative for years until deciding in 2009 that the existing wireless carriers, especially Verizon Wireless, AT&T, Jitterbug and Sprint were willing to offer wireless health services themselves.

Early in 2009, just before MobiHealthNews broke the news that LifeComm was shutting down, Qualcomm presented some of the devices and services that LifeComm was planning to support: A mobile phone with an embedded glucometer for diabetics and a mobile personal emergency response system (MPERS) medallion for seniors. For the MPERS device think "Lifeline on steroids," a Qualcomm representative said, a medallion small enough for users to wear around their neck, but it still contains the "guts" of a mobile phone and an accelerometer to detect activ-ity.

“Qualcomm is reviewing its options with LifeComm in light of current capital market conditions that have prevented LifeComm from raising the third-party capital necessary to fully develop its initial launch product,” a Qualcomm spokesperson told MobiHealthNews in July. The devices and services that were set to launch through LifeComm ended up forming into their own start-ups and companies, Qualcomm said at an event in early December. In a lot of ways, the shuttering of LifeComm was a good news story for the emerging wireless health industry, Qualcomm's Clint McClellan noted. It meant that wireless carriers were willing to support these devices and services. Not needing LifeComm should be seen as a bright spot.

Carriers establish their own health focused business units

While most of the major U.S. carriers ramped up their M2M businesses in 2009 — business units or joint ventures that clearly have a stake in wireless health—a few carriers around the world actually launched healthcare dedicated business units, too.

Both Vodafone Group and Verizon, the two owners of Verizon Wireless (45 percent and 55 percent, respectively), launched healthcare focused business units during the fourth quarter of the year.

“I personally believe that the mobile phone has a very significant role to play in the provision of healthcare,” Vodafone Group CEO Vittorio Colao told attendees at the Mobile Healthcare Indus-try Summit in London this December. Colao explained that key use cases for mobile in healthcare include: the simplification of clinical work flows, statistical analysis of record keeping, supporting the chronically ill at home as well as reaching under-resourced and geographically dispersed



communities.

In the short term, Colao said that many mobile health services can be created without having to develop new technology. More often than not we think about mobile health as very complex systems, which may be right for developed markets, but in general technology is not the prob-lem. For developing markets especially, many pilots have shown the power of mobile healthcare, Colao said, but unfortunately there has been little success in scaling these projects. Vodafone Group recently established a new mobile healthcare unit that aims to work with medical organi-zations, governments and pharmaceutical companies to fully understand what the needs are.

“We want to start listening to governments and listening to pharmaceuticals to understand what the needs are. It is clear that there is a pressing need for a reevaluation for how we deliver health services in the coming year,” Colao said. “It is also clear to us that mobile technology has a role to play in how we … provide better service and improve healthcare for those in mature — and more importantly — in developing markets.”

Verizon launched its healthcare focused business unit in November: Verizon Connected Health Care. On the wireless front, the group is working with a hospital in New Jersey to build a collabo-ration service that allows specialists to conduct video consultations via mobile devices:

“Also coming are even more mobile capabilities, including taking video collaboration down to the mobile device. For instance, Verizon is already working with a hospital in New Jersey, [Verizon's managing principle for healthcare, Nancy] Green said, that is building a collaboration service with mobile endpoints, allowing specialists to do consultations from almost anywhere.”

Verizon offers video consultations for applications like “tele-stroke” which allows physicians to review patients’ cases via live video to determine whether they should wait for a doctor to visit or be rush to emergency care. Green believes these services will become much more effective once remote patient monitoring of vitals and video collaboration applications come into the mix, too.

Jitterbug ramps up wireless health services

By any measure GreatCall's Jitterbug mobile phone service for seniors has led the pack of carriers offering or developing wireless health services for their users. In the past year Jitterbug has become profitable; added Internet capabilities to their phones; switched their network from Sprint to Verizon Wireless; acquired a mobile personal emergency response service start-up called MobiWatch; conducted pilots with various wireless health vendors like Meridian and Well-Doc; and launched a Services Store stocked with wireless health services.

AT&T develops personal health devices; enables remote medical services

While AT&T is the exclusive US carrier for the Apple iPhone, which has spurred much of the



direct-to-consumer wireless health market this past year, the carrier itself has also made moves to offer wireless health services directly to its users. For the past year AT&T has worked with Texas Instruments and start-up 24Eight on a “smart innersole” technology that uses wireless sensors to monitor the user's balance and gait. At the end of the year AT&T unveiled a prototype it called “smart slippers,” which target the senior care market. One analyst estimated the smart slippers and their service package could run about $100 per month.

AT&T also announced it was providing cellular connectivity to Vitality's GlowCaps device, which is a pill box cap that fits most standard pill boxes and glows when the user fails to take their medi-cations.

AT&T is also working with Hollywood-based Wound Technology Network to support the physi-cians' group's remote wound care management service. WTN is now using HTC smartphones running on AT&T's data network to access patient records and view images of wounds. WTN previously inked a deal with Verizon Wireless to support laptop data cards for its physicians. Lab workers at AT&T’s quality testing lab in San Antonio, Texas also recently let it slip that the carrier is testing a number of wireless devices and services, including mobile medical tracking systems.

Sprint’s varied wireless health approach

Along with Johnson & Johnson company Lifescan, Sprint funded a mobile phone-based diabetes management system pilot conducted by WellDoc. WellDoc found that the pilot led to a 2 percent A1c drop among many of its pilot users.

As noted above, Sprint announced this year that it would work with M2M company DataSmart to help embedded device makers to bring their products to market sooner.

Sprint teamed up with GE Healthcare update San Antonio, TX-based Methodist Healthcare’s six hospitals with a converged wireless network platform. The care provider said that since the system could more easily centrally manage the group's communications, the number of IT employees might decrease, which opens up an opportunity to hire more care workers.

Sprint partner mVisum announced this year that it was working with the Veteran Affairs to test a system that aims to get critical medical information to a physician while they are on their way to a patient’s bedside.

Conclusion: Carriers are out in front

More so than any other potential wireless health service provider, wireless carriers are currently leading the way for managed wireless health services. Carriers have an engaged user base and the tools are already at their disposal to offer wireless health services to consumers. It looks like in the year ahead that carriers will continue to dominate as the service providers of choice. In a few years carriers will begin to work more closely with care providers not just to offer services to the care facilities themselves but also to offer them to the care providers' patients.



Kaiser Permanente leads the pack on wireless health

While a number of care providers have researched and developed a number of wireless health services, the clear leader of the pack in 2009 has been Kaiser Permanente. At the very beginning of the year, Kaiser announced that it had just completed a pilot for text message appointment reminders with SMS vendor Mobilestorm. The pilot resulted in 0.73 percent fewer “no shows” across one of its care facility's population, which prompted the care provider to work toward a national rollout of the service.

Kaiser Permanente's Director of Enterprise Engineering Carlos Matos told MobiHealthNews during an interview at the HIMSS conference that text messaging reminders are just the begin-ning:

“On the SMS side we have had some good success with [text message] integration where we send notifications directly to member [mobile phones] for a variety of reasons,” Matos said. “Our plan is to stimulate more immediacy for our members and also make these communications more feature rich by integrating Kaiser Permanente’s carepoint solutions. We want to be able to provide outreach methods that traditionally took the form of mailings and convert those com-munications to kp.org or SMS.”

Matos also noted that text messaging could help with the care provider’s population care man-agement. For example, a diabetic who has not had an A1c exam in a certain amount of time may be notified based on several different elements pulled from his EMR that it’s time to come in for an appointment. (Similarly, Mount Sinai recently announced a pilot it was conducting with Care-Speak to send adherence reminders via text messages to a teenager who had undergone a liver transplant recently. The pilot demonstrated a decrease in the incident of rejection episodes for the teens.)

Kaiser Permanente is also “white boarding” a number of other innovation projects. One of the next services Matos said to expect coming out of Kaiser’s innovation team may be support for connected biomedical devices. These would be simple ones like wireless-enabled or USB connected blood pressure monitors that KP can equip its patients with for at-home use. These really improve clinical outcomes, Matos said, and they let providers capture very granular infor-mation that they can then use to make decisions based on that data analysis. Another example may be a connected weight scale that helps providers track a congestive heart failure patient’s weight over time.

Kaiser's Medical Director of Health Informatics & Web Services Ted Eytan told MobiHealthNews in an interview this year that the value of mobile "comes back to getting that information in a useful way -- right when you need it. What Kaiser Permanente is very good at is taking really large systems and making them very accessible and flexible, which is something a lot of Health 2.0 companies can't do as well. We watch some of the mobile [health] demos going on and try to take what we can learn from them and apply it to our own system, but our goal, of course, is

Care Providers Push Pilots, Look for Results


always to improve the interaction between patient and doctor in order to improve medical care."

At Kaiser the focus is clearly not on the technology or wireless in particular, but regardless, the group is pushing ahead with more wireless health offerings than most care providers in the US.

The US Army and the Department of Veteran Affairs (VA)

One of the first wireless health deals inked in 2009 was between AllOne Health and the Army for a mobile phone based communication system that allowed the Army's care givers and physicians to check-in and remotely monitor “wounded warriors” who had recently returned from the war with traumatic brain injuries. The Army licensed AllOne Mobile for 10,000 soldiers and is rolling it out on an incremental basis.

A key wireless health partner of Sprint and BlackBerry's, mVisum, has also worked with the VA this year on wireless health solutions. mVisum is equipping physicians with a mobile phone appli-cation that allows them to access patient health information while they are on their way to the patient's bedside.

Intel also announced that a regional division of VA was now a customer: The division of the VA had purchased a number of the company's remote patient monitoring, home health touchscreen devices: Intel Health Guides. Intel also inked deals with Memorial Hospital & Health System and a number of other Indiana-based home health agencies.

Apple's iPhone: A game changer for care providers?

A number of hospitals began to take a look at how they could better integrate Apple's iPhone into their overall clinical workflow once it became clear that a majority of physicians (64 percent) now use smartphones (and a growing number of them favor iPhones.) One of the first hospitals to announce its infatuation with the iPhone was Pennsylvania-based Doylestown Hospital, which was the first to be profiled on Apple's corporate site for equipping its care workers with iPhones. The hospital connected the iPhones to its Meditech EMR system. Houston-based Memorial Hermann care facilities followed as a second hospital profiled on Apple's site. Then, news broke that Apple was working directly with EMR vendor Epic Systems to integrate iPhones into Epic's EMR solution for a hospital at Stanford University. Rumor has it that the iPhone-EMR solution will roll out early next year and big care providers like Kaiser Permanente are already taking a look.

One start-up that has begun to capitalize on the iPhone's growing popularity among care provid-ers is Voalte, a Florida-based startup the offers an iPhone-enabled voice, alarm, text service for nurses. The company piloted its application for nurses at Sarasota Memorial Hospital.

Care providers begin to court wireless remote monitoring

A number of care providers are beginning to develop and launch wireless remote monitoring



services for various chronic conditions: Partners Healthcare in Boston even spun out a start-up, named Connected Health, that is initially focused on a service for wireless remote monitoring of blood pressure through a connected cuff. The start-up just completed a pilot with Boston-area employer EMC.

A number of care providers are also taking a look at wireless sensors: London-based St. Mary's Hospital plans to trial Toumaz Holding's wireless sensor for vital sign monitoring. The bandaid-like sensor monitors skin temperature, heart rate and respiration. Wireless sensor-enabled home-based monitoring startup WellAware inked deals with two senior care facilities: Evangeli-cal Lutheran Good Samaritan Society and Hastin. WellAware will equip the outpatient centers with wireless sensors for senior care. WellAware inked the deals this fall – only a few weeks after the startup launched. Mayo Clinic and STMicroelectronics are collaborating on a wireless cardiac monitoring service that will monitor heart rate, breathing rate, and physical activity. St. Francis Hospital is testing out St. Jude Medical's wireless-enabled, remote monitoring pace maker, which transmits data to the server at least once a day. Finally, Ohio Health has been testing out iShoe's smart innersole technology for fall prevention. iShoe is expected to launch in 2010 with a $100 pricepoint, according to one estimate.

Health insurers offer wireless health services

Health insurers have also begun to take an active role in offering wireless health solutions to their members:

Significa Insurance Group (Significa) and Erin Group Administrators both inked deals with AllOne Health to allow their members to view, manage and exchange their health information with their physicians. AllOne Mobile works on a wide variety of mobile phones so the offering is easier for an insurance company to provide. When wireless health offerings are tied to a specific device, it makes more sense for the wireless carrier that supports that mobile phone to offer the service. Harvard Pilgrim made headlines this fall when it announced plans to pilot MedMinder's wireless-enabled PillBox for chronic kidney disease (CKD) patients. CKD affects about 26 million people according to the companies and it has no cure. By adhering to the right medication regimen, however, the disease can be managed. Harvard Pilgrim is piloting the system to deter-mine its efficacy.

Blue Cross Blue Shield's venture arm has been particularly active in investing in wireless health startups this year: The firm made two big investments, one in Myca and another in Phreesia. Phreesia offers a touchscreen device that enables physicians' offices to more easily check-in patients and determine their insurance coverage immediately. Myca powers a physician collabo-ration platform that integrates everything from billing to EMRs to other administrative tasks and allows physicians to interact with patients via email or even text message.



While wireless carriers and care providers are perhaps two of the most important players in wire-less health after the patient, of course, this past year saw a growing role for industry organiza-tions, academic institutions and non-profit institutes. The groups evangelized the industry through events and educational seminars and pushed regulators and lawmakers to ripen the market for innovation. Their guidance has shepherded start-ups closer to launch and accelerated the overall progress of the industry in the past year. Here are the players worth keeping an eye on:

West Wireless Health Institute

In March the West Wireless Health Institute founded thanks to a $45 million gift from the Gary and Mary West Foundation and support from Qualcomm and Scripps Health. The San Diego-based Institute has since worked to take wireless medicine out of the lab and into the market-place. Don Jones, Qualcomm’s Vice President of Health and Life Sciences serves as the Institute’s Founding Board Member while Scripps Health’s Chief Academic Officer Eric Topol is the Institute’s Chief Medical Officer. Gary West is the Institute's chairman and Mehran Mehregany recently joined the team as the Institute's executive vice president of engineering and chief of engineering research. The organization is currently recruiting for other leadership positions.

At the time of the Institute's founding, Topol noted that part of the Institute's mandate is to help validate the hundreds of wireless health devices that may already have FDA approval but are looking for clinical validation to make it to the market.

By mid-year the WWHI announced that the first start-up it would help bring to market was wire-less sensor-enabled remote monitoring start-up Corventis, which specializes in detecting heart fluid status for patients with heart disease. The company uses a peel-and-stick, bandaid-like wireless sensor that can interface with a wireless device to track and monitor patients’ vital signs. The WWHI is currently facilitating clinical trials for the company.

The WWHI has also been particularly effective at educating the industry and others about the wireless health opportunity by evangelizing key conditions that wireless health solutions could better manage and assembling data about the opportunities to lower costs in the overburdened US healthcare system through the use of wireless remote monitoring technologies.

UCLA Wireless Health Institute

The Wireless Health Institute (WHI) was established last year as a community of UCLA experts from engineering, medicine, nursing, pharmacology, public health and other disciplines that aims to improve “the timeliness and reach of health care through the development and applica-tion of wireless, network-enabled technologies integrated with current and next-generation medical enterprise computing.” In 2009 UCLA appointed Dr. Patrick Soon-Shiong as executive director of the university's Wireless Health Institute.

Alliances and Institutes Accelerate Time to Market


Soon-Shiong told MobiHealthNews in an interview that the Institute’s mandate is to not only enable the development of these technologies but also to foster wireless health start-ups and test the wireless health technologies to prove their efficacy: “I believe the only way we can truly transform healthcare is if we enable both patients and providers to have access to data that is truly ‘outcomes actionable,’” Soon-Shiong said. “Evidence-based, outcomes-driven data at the point-of-care is the goal. Those few words have a deep meaning to them — evidence-based outcomes based point-of-care. That is the holy grail for healthcare transformation.”

Soon-Shiong noted that medication adherence is a key problem that wireless health can work to solve. He also pointed to a few other wireless health technologies he thinks encapsulates the potential of the technology: wireless biometric devices; sensors that can help detect developing foot ulcers before diabetics realize they are getting them; “smart” canes that use accelerometers to notify caregivers a patient may soon fall; and a wireless lens-less microscope that can use a phone’s camera for diagnostics.

Continua Health Alliance

The Continua Health Alliance, a consortium of more than 220 wireless and medical companies, which aim to create an interoperable ecosystem of medical devices and systems, has been busy this year. After announcing its first two Continua-certified products, the Alliance also announced two new wireless technologies for its Version 2 guidelines: ZigBee and Bluetooth Low Energy. Since then Continua has announced additional devices have been certified as Continua-approved and interoperable.

The Continua Health Alliance has also been recognized as one of the key evangelists for remote patient monitoring on Capitol Hill. Continua's lobbying efforts helped convinced lawmakers to include remote monitoring in the US healthcare bill.

Apart from ensuring interoperability among devices and lobbying the legislature, Continua's representatives have been at most of the wireless health focused industry events in the past year. Chuck Parker, Continua's executive director gave a stirring speech at an event in Seattle this past spring. Parker said that remote patient monitoring doesn’t need to do any more trials or pilots. He said that the Department of Veterans Affairs (VA) has done remote patient monitoring pilots with about 30,000 patients over the past four years. That’s enough pilots, Parker said, we don’t need to do any more pilots for remote patient monitoring; we need to move to deploy-ments, and look to the VA for their pilots’ findings.

CTIA, The Wireless Association

CTIA is an industry association for the wireless industry that hosts a number of events through-out the year and also serves as the wireless industry's liaison with Congress and various regula-tory bodies. CTIA quickly became a champion of wireless health in 2009 as it made the emerging industry a focus at its November event in San Diego. Apart from bringing in more than two-dozen



wireless health start-ups to show off their wares, the association also successfully courted the AARP to participate in the wireless health discussion.

During the summer CTIA organized a wireless health event at the U.S. Senate, which brought the chairman of Intel and other wireless industry luminaries to discuss the opportunity that wireless presents to the healthcare industry. CTIA also lobbied the FCC not to enact net neutrality legisla-tion for wireless data networks, because, the CTIA argued, regulating the carriers' ability to manage wireless data traffic could stymie innovation particularly in the emerging wireless health industry. Requiring carriers to treat all data traffic the same would make it difficult for carriers to ensure critical medical information reaches its destination on time or in tact, the association argued. CTIA also suggested that the FCC make available more wireless spectrum for carriers citing the growing interest in wireless health services.

American Telemedicine Association

The American Telemedicine Association (ATA) was created in 1993 by a group of doctors who were using video conferencing links between larger health centers and rural clinics. The ATA now describes itself as part trade association and part professional association, because its members include clinicians, physicians, nurses as well as hospitals, institutions, government organizations, corporations, providers. The ATA offers educational work, including its annual conference, advo-cacy in Washington and elsewhere. The ATA also has special interest groups, about 15 different member groups in various areas that provide networking, and it is beginning to create practice guidelines related to healthcare.

Why is the ATA interested in wireless healthcare? Pike & Fischer recently predicted that the market for telemedicine devices and services will climb to $3.6 billion in annual revenue over the next five years largely thanks to a push from wireless technologies, data compression and smart-phones. Telemedicine will be dominated by wireless technologies during that time period: More than 70 percent of telemedicine will be wireless healthcare, according to the firm.

m-Health Innovation Centre

This winter the GSM Association announced a partnership with the University of Manchester in the UK to establish an m-Health Innovation Centre in the city of Manchester. The groups said that the center will have a UK focus to start and aims to promote healthier lifestyles and early inter-vention through the use of wireless technology, which it believes can improve health outcomes.

The Manchester m-Health Innovation Centre plans to conduct multidisciplinary research, bring-ing together researchers, healthcare organisations and industrial partners to conceive, develop and evaluate mobile health innovations. A major focus will be on citizen-led health and wellbe-ing, using mobile technology to enable people to play a more active role in determining their own health, providing a more personalized and responsive interface to public services. The new center hopes to provide a forum for sharing ideas, in-depth analysis of the market for wireless



health, facilitation of pilot trials as well as mHealth education and training.

mHealth Alliance

Early in 2009, the Vodafone Foundation, UN Foundation and the Rockefeller Foundation officially launched a new joint venture called the mHealth Alliance. By mid-year it appointed wireless industry vet David Aylward to helm the international organization as its executive director.

The mHealth Alliance has a decidedly global health focus with a particular interest in bringing the wireless health stakeholders to developing markets. Aylward told MobiHealthNews in an inter-view that no group has managed to scale mHealth services—not in developed or developing markets. There haven't even been large trials yet. Most of what is out there are small, non-sustainable proofs of concept. The mHealth Alliance aims to support and facilitate the integra-tion of services so that rather than having a series of point services these services will become integrated and part of the healthcare system already in existence in that market.

Integrating those services is just one mission of the Alliance. Integrating those kinds of services into underlying healthcare systems, e-health to use the short language, is a second. Getting sustainable economics under both of those is a third. Researching and showing the health and economic effect of doing that is a fourth. Underneath those there are more procedural activities, support activities like communications and connecting people together to technology initiatives.

The mHealth Alliance recently announced a partnership with the Vodafone Americas Foundation to create an mHealth Alliance Award for the developer of an innovative wireless technology with the most potential to address critical health challenges, especially in developing regions. The prize for the award includes cash and benefits totaling $50,000 and guidance from the Alliance about developing the application.



“You are not going to get paid for cool ideas,” IntelliDOT CEO and founder of CardioNet James Sweeney told a group of wireless health entrepreneurs at the Wireless Life Sciences Alliance event this past spring. “You are not going to get paid for saving lives. You are not going to get paid for anything unless you can prove that you can save them money.... In the world we’re moving into, more than ever, if you can’t justify the cost benefits, then you will fail,” Sweeney said. “In my view, getting the FDA’s approval is not nearly as hard as getting the CPTs and insurance reim-bursement approvals.”

CardioNet, the wireless remote patient monitoring company that Sweeney founded is perhaps the poster child for the first generation of wireless health companies. The company has the distinction of being the only pure-play wireless health company to have offered an initial public offering and one of the few to acquire reimbursement from the Centers for Medicaid & Medicare Services (CMS). At the very end of 2008, CardioNet secured a CPT that enabled it to collect $1,123.07 for its Mobile Cardiovascular Telemetry Service.

After months of rumors that Highmark CMS planned to reduce its reimbursement rate for Cari-doNet and other MCOT services, the payer did. In July CardioNet announced that Highmark Medicare Services planned to slash its reimbursement rate for MCOT services to $754 per service, effective September 1, 2009. Highmark CMS gave no explanation for the cut other than that it believed it was the true value of the service.

CardioNet's reimbursement dip sent the company's stock tumbling and forced it to announce plans to cut back on operational costs to sustain its business.

Analyst firm Frost & Sullivan sees a bright future for remote patient monitoring, but the key for the industry is reimbursement: The market for remote patient monitoring is set to achieve double digit growth in North America, according to the firm, so long as successful payment strat-egies are implemented. Last year the remote patient monitoring market made more than $98.2 million, but the market could top $428.6 million by 2015. Frost points to direct reimbursement as one type of payment strategy that needs to mature for the market to grow at this rate:

“At present, it seems very unlikely that any significant progress will be made toward direct reim-bursement in the next two to five years,” Zachary Bujnoch, industry analyst, Frost & Sullivan stated in the firm’s release. “As a result, market participants are forced to seek alternative payment strategies, and while some of these have proved successful, the huge billion dollar market potential this space possesses is unlikely to be reached without some form of direct reim-bursement.”

Two to five years before significant progress is made toward direct reimbursement? If Frost is correct, then more wireless health start-ups will pursue a direct-to-consumer model or an indirect to consumer model through their employers, who are financially motivated to keep their employees healthy and working.

Reimbursement Rises and Falls


Some online health services began to see some progress on the reimbursement front this past year: New York-based MPV Health Care plans to reimburse for more than 22,0000 physicians who use McKesson subsidiary RelayHealth’s webVisit consultations with their patients.

Mobile health companies, however, remain frustrated by CMS. Chronic disease management service provider BeWell Mobile's Vice President and General Manager Greg Seiler believes that CMS should help wireless health companies better understand the reimbursement eligibility process:

“It’d help to have clear support and guidance coming from Washington for how to enter the CMS system and get reimbursed for technologies that work,” Seiler told attendees of the Wireless in Healthcare IT event held at a Senate office building this past March. “What are the metrics for demonstrating the technology works? How can we get them reimbursed? [Answers to these questions could help mHealth move forward] and help to mitigate some of the risks that we would otherwise enjoy taking on.”

Even devices that are much cheaper than the ones CMS reimburses for currently have trouble getting an audience with the payer. The New York Times published a feature entitled Insurers Shun Multitasking Speech Devices, this past September, that focused on a patient with A.L.S. Since the muscles around her mouth and throat no longer allowed her to speak, she used an $8,000 computer that Medicare approved with software that turns typed words into speech. In this patient's case, however, a much cheaper ($190) iPhone app called Proloquo2Go served her needs better as a person living a mobile life. Payers do not seem to be interested in taking advan-tage of consumer devices' cheaper price points, which could, ultimately help curb healthcare expenditures.

CMS, however, has yet to answer Seiler, Proloquo2Go and the rest of the industry's calls for a seat at the table. It's a conversation that is not taking place, and if Frost & Sullivan is right, it may not for a few more years. Until then, wireless health companies need to keep pounding on CMS' door, while proving their products efficacy and perhaps eyeing a different go to market strategy in the meantime.

Reimbursement Rises and Falls


There are currently 1.2 million people who use mobile fitness products to track their vital signs while working out. It starts with fitness, but use cases for health and medical wireless health services are set to become increasingly popular. A recent ABI report found that 90 percent of the current wearable wireless sensor market is dominated by the fitness industry. By 2014, the market will swell to 400 million units, thanks in large part to growing use of sensors for health-care and medical uses.

With resistance from payers and uncertainty about the stability of a business model dependent on their steady support, a number of wireless health service providers and device makers have turned to direct to consumer as the best go-to-market strategy. Others never planned to become a part of the healthcare system and focused on creating personal health devices with an eye on the consumer market from the outset.

During the course of the year a number of breakthroughs occurred for the wireless health consumer play: Best Buy invited wireless health startups to pitch it for shelf space and then launched fitness sections in 40 of its stores across the US; App developers created thousands of health, fitness and medical iPhone applications available for download directly from the App-Store; A myriad of personal health devices began selling their services direct to consumer via online stores like Amazon.

Best Buy begins selling personal health devices

One of the largest big box electronics stores took an interest in personal wireless health devices this past year: At the Microsoft Connected Health Conference in June, Best Buy teamed up with Microsoft’s HealthVault team to invite device makers to pitch the electronics store’s executives in a private meeting at the event: “If you believe that your product or solution can wow health-conscious shoppers at the largest consumer electronics retailer in the United States, this is your chance to make it happen,” stated the Microsoft-Best Buy invitation. The invitation also explained that “outstanding solutions providers” would have the opportunity to discuss collabo-ration opportunities with Best Buy during a special dinner later this summer.

A few months later Best Buy announced that 40 of its stores in the U.S. had begun offering personal health solutions devices like pedometers, Bluetooth-enabled weight scales and blood pressure monitors.

“New technologies are emerging daily to help people plan, monitor, and enhance their health and fitness activities,” Best Buy stated in its press release. “Yet finding the ways and the time to stay fit and motivated can seem more complicated than ever before. Starting today, Best Buy customers in select markets from Washington, DC to Denver can turn to the nation’s largest consumer electronics retailer for help in satisfying their health and fitness equipment and man-agement needs.”

Consumer Health: The Answer to "Who Pays?"


iPhone demonstrates consumer demand for mobile health

”Now here’s a class [of services] that we think will be really interesting: medical devices,” Apple SVP of iPhone Software Scott Forstall announced at the sneak peek event for iPhone 3.0. during the summer. Forstall then explained that the new iPhone OS will allow application developers to sync medical devices like blood pressure monitors or blood glucose monitors via both Bluetooth and USB. “So imagine the possibilities,” Forstall continued. “We think this is profound.” Forstall then invited a representative from Johnson & Johnson subsidiary Lifescan who demonstrated a concept iPhone app that interfaced with a connected blood glucose meter device.

Since the iPhone 3.0 event in June, medical device makers and chronic disease management service providers have all been forging mobile strategies.

iTMP is one startup that was early to market with a peripheral device for the iPhone: SM Heart Link, is a “wireless bridge” that can collect data from wireless sensors like heart rate chest straps or cycling sensors on bikes and send them to an iPhone for display and tracking. Wireless remote monitoring company MedApps looks to be integrating its system with smartphones, including the iPhone perhaps as soon as next year. Most wireless sensor startups, including Corventis, Sotera Wireless and Proteus Biomedical have all indicated that their sensors would interface with an application on the iPhone. Those startups are not pursuing a consumer health market strategy initially, but many expect them to create cheaper, consumer versions of their sensors in the future.

Of course, the market for peripheral medical devices that interface with the iPhone could be a big market opportunity, however, the real success story for the wireless health services via mobile phones in the past year has been the rise of health, fitness and medical applications themselves. No other smartphone app store comes close to iPhone's thousands of health-related apps. From symptom navigators to chronic disease management tools; from medical reference guides to remote monitoring applications; from medication adherence apps to sooth-ing relaxation applications. Chances are if you have thought of a potential health-related applica-tion, there's a version of it already in the iPhone App Store.

BlackBerry has also begun ramping up its health-related applications in its App World store and they include a wide variety of applications – many of them also offered for iPhone. BlackBerry, however, only offers a few hundred health apps compared to the thousands available for iPhones.

Examples of other wireless personal health devices in the market

Zeo Personal Sleep Coach - The Zeo headband uses the startup's patent-pending SoftWave sensor technology to accurately and safely measure the user's unique sleep patterns through the electrical signals produced by the brain. Zeo records those signals and can track which level of sleep the user is in and for how long based on the data. That data is then transmitted to the Zeo



alarm clock, which acts as a gateway to send the data to Zeo's server where users can log-in and review their sleep habits. Zeo is available via Amazon.com or directly from the company's web-site.

GlowCap – Vitality's GlowCap is a smart pillbox cap that can fit the average pillbox. GlowCap glows different colors when users forget to take their medication – it uses an accelerometer to determine when the pillbox is opened and makes a time stamp. The GlowCap can also alert care-givers when a person forgets to take their medication and can even call the pharmacy to get a refill. GlowCap is currently available via Amazon.com but the company does not believe direct to consumer will be its most successful distribution channel. Vitality hopes to get pharmaceutical companies or others to subsidize GlowCap for patients' use. AT&T recently announced that it would provide cellular connectivity for the product.

Fitbit – This personal fitness device is currently sold out and on backorder, according to the com-pany. Fitbit tracks calories burned, steps taken, distance traveled and sleep quality by using an accelerometer. Fitbit tracks its users' motion in three dimensions and converts this data into usable information about daily into useful information about your daily activities. Fitbit uses a wireless base station that is positioned in the home – whenever a user walks near the basesta-tion the data is uploaded to Fitbit.com where users can analyze their personal health data. Fitbit is sold through the company's website but it is currently out of stock and not filling new orders until January 31, 2010.

Philips DirectLife – Philips activity monitor DirectLife measures body acceleration in three differ-ent directions and combines that information with the user's age, gender, height and weight. The measurements are then converted to energy use, or calories burned. DirectLife's online program helps users establish goals and encourages and motivates users to increase their goals to exercise more in successive weeks. The device itself is tiny, smaller than a matchbox, and has no display screen. Instead it has a half dozen green LED lights that indicate to the user how close they are to meeting their exercise goal for the day. The service is currently available from the DirectLife web-site.



Wireless Health Venture Capital in 2009

There were 15 venture capital investments announced during 2009 and 11 of them were for wireless remote patient monitoring start-ups. The remainder included a start-up working on a converged platform for physician-patient communications, a smartphone app developer focused on fitness games, a call-in physician consultation service, and a tablet-based patient check-in device for physician offices. While there were few, this year's investments cover a variety of wire-less health business models and offerings.

In September MedMarket Diligence noted that investments and other financings in the medical device sector topped $400 million in July and August. The $22 million round that wireless health start-up CardioMEMS secured, led the pack. MedMarket predicted another $400 million in investments in medtech for the month of September alone.

By October venture capitalists focused on healthcare were hedging their bets based on the direc-tion US healthcare reform was heading: VCs like Psilos and Chrysalis looked to fund companies that help people stay healthier and manage chronic diseases, figuring this is one way the govern-ment will ultimately move to take costs out of healthcare.

In November following the CTIA Wireless IT & Entertainment event in San Diego, where more than two dozen wireless health start-ups demonstrated their solutions, wireless industry veteran analyst Chetan Sharma predicted a “lot of investment” would flow into the sector in the coming days.

One venture capital firm, Mohr Davidow Ventures (MDV), which invested in wireless sensor start-up Corventis in the past, told MobiHealthNews that it was actively pursuing start-ups like Corventis that collect clinically-actionable data for point-of-care. MDV was chiefly interested in companies at the 510K level of FDA regulation. Products that require long, multi-year clinical trials before getting an FDA regulatory decision were not of interest. For the most part, the list of venture capital deals in the chart on the next page follow that trend.


VentureCapital 2009

Company Amount LocationDate Announced Investors Company Description

CardioMEMS $22.1 million Atlanta, GA 08/26/09

Arcapita Ventures, Boston Millennium, Foundation Medical

Developer of implantable wireless sensors that track cardiac output, blood pressure and heart rate (more)

Autonomic Technologies $20 million Menlo Park, CA 05/08/09

Lead Investor: InterWest Partners; Also: Kleiner Perkins Cau eld & Byers, The Cleveland Clinic

Developer of implantable devices that aim to soothe severe headaches (more)

Phreesia $11.6 million New York, NY 02/20/09

Lead Investor: BlueCross BlueShield Venture Partners; Also: Polaris Venture Partners, HLM Venture Partners and Long River Ventures

Developer of an automatic patient check-in device and service that aims to improve patient-provider relationship (more)

BiancaMed $9.8 million Belfast, Ireland 07/20/09

Lead Investor: Seventure Partners; Also: ePlanet, Enterprise Ireland, and ResMed

Developer of wireless monitoring devices, including a motion sensor that detects heart rate and respiration (more)

TelaDoc Medical Services $9 million Dallas, TX 12/04/09

Lead Investor: HLM Venture Partners; Also: Cardinal Partners, Trident Capital

National network of primary care physicians that diagnose illness, recommend treatment, and prescribe medication over the phone (more)

WellAware $7.5 million Charlottesville, VA 12/08/09Valhalla Partners, .406 Ventures.

Developer of wireless remote monitoring systems that track the daily activities of cared for individuals in the home (more)

Myca Health $5 million San Francisco, CA 10/06/09BlueCross BlueShield Venture Partners, Sandbox Industries.

MycaHub combines an EMR, a comprehensive admin system, and the ability for doctors to communicate with their patients via a variety of channels. (more)

Echo Therapeutics $3.6 million Franklin, MA 12/04/09Investors include Cotswold Foundation

Echo is developing a wireless blood glucose monitor for diabetics.

BL Healthcare $3 million Foxborough, MA 08/06/09 undisclosed

BL's platform, TVx, gathers info from Bluetooth-based wireless medical devices at home and displays it on the TV.

Monica Healthcare $1.6 million Nottingham, UK 04/27/09

Lead Investor: PUK Ventures; Also: Catapult Venture Managers, University of Nottingham

Developer of wireless technology for monitoring the health of expectant mothers and babies (more)

Wireless Medcare $535K Roanoke, VA 12/11/09Carilion Biomedical Institute, Optimum Sensor Holdings

Developer of medical applications for wireless and web-enabled devices (more)

GymFu $160K Hampshire, UK 12/01/09 Lead Investor: Channel 4's 4iP

Developer of motion-detecting iPhone tness apps that include peer challenges to keep users motivated

eCardio Diagnostics undisclosed The Woodlands, TX 07/01/09 Sequoia Capital

Service provider of remote cardiac monitoring for arrhythmia diagnosis (more)

MiLife undisclosed Bedford, UK 01/16/09New Venture Partners, Unilever Ventures

Developer of a personalized online tness coaching system and wireless monitoring device (more)

Zephyr Technology undisclosed Annapolis, MD 06/18/09 Motorola Ventures

Developer of real-time physiological and biomechanical monitoring technology for defense, rst responder, training and research markets (more)

VentureCapital 2009

Page 24

http://mobihealthnews.com/4094/wireless-sensor-company-cardiomems-gets-221m-in-vc/

http://mobihealthnews.com/2941/the-5-mhealth-start-ups-that-received-venture-capital-in-2009/4/


http://mobihealthnews.com/3302/sleep-monitoring-start-up-scoops-up-98m-in-vc/

http://mobihealthnews.com/5660/teladoc-scoops-up-9m-in-venture-capital/

http://mobihealthnews.com/5695/wellaware-raises-7-5m-in-venture-capital/

http://mobihealthnews.com/5042/connected-health-myca-hello-health-and-qualcomm/


http://mobihealthnews.com/5741/shorts-start-up-raises-535k-wireless-brain-dod/

http://mobihealthnews.com/3001/sequoia-capital-invests-in-cardionet-competitor-ecardio/

http://mobihealthnews.com/2941/the-5-mhealth-start-ups-that-received-venture-capital-in-2009/


Wireless Health Industry Deals in 2009

During the course of 2009, MobiHealthNews chronicled 73 business deals between two or more companies or organizations active in the emerging industry. We defined a deal as an acquisition, pilot, program, joint venture, or product or service launch in conjunction with another company.

“For many global firms, the fastest path to market leadership will be through acquisition,” Invest-ment firm TripleTree's research director Chris Hoffmann told MobiHealthNews. “This consolida-tion may not come in the same flurry as we’ve seen in enterprise software, but some thoughtful strategic deals will begin to occur. Because many of the questions surrounding mHealth and Wireless Health solutions center on ‘who pays for them’, early M&A activity may be focused on those solutions demonstrating recurring revenue growth or meaningful end user (or patient) retention.”

The 73 deals summarized here could serve as a timeline for wireless health activity in the past year. The deals are ordered chronologically, beginning with AllOne Health's massive pilot with the U.S. Army, which licensed AllOne Mobile for more than 10,000 wounded warriors managing traumatic brain injuries. The charts on the following pages are testament to the work accom-plished this year by wireless health companies, and it points to many more deals in 2010.

WirelssHealthDeals 2009

Page 25

WirelssHealthDeals Q1

Company A Company B, etc. What was the deal?Date Announced Other details?

U.S. Army AllOne Health, Diversinet

Army to pilot AllOne Mobile to stay in touch with “wounded warriors” through their mobiles. (more) 01/14/09

Army licensed the technology for 10,000 soldiers, speci cally those with traumatic brain injuries.

Google Anvita MobileAnvita developed a mobile viewer of Google Health for Android. (more) 02/05/09

The Mobile Viewer allows users to view but not edit pro le information as well as current prescriptions, existing health conditions, known allergies and more.

Kaiser Permanente MobilestormCompleted a pilot for text message appointment reminders. (more) 02/05/09

KP worked with Mobilestorm for the pilot, which showed 0.73 fewer “no shows.” National rollout to follow.

IBMContinua Health Alliance, Google

IBM and Continua to create guidelines for wireless medical devices to connect to Google Health. (more) 02/12/09

As part of the announcement, IBM said it had integrated its Information Management, Business Intelligence and WebSphere Premises Server sensor event platform into Google Health already.

Alcatel-LucentMotorola, HP, Samsung, others

Companies formed, ng Connect, a group for vendors looking to create next-gen wireless devices with Alca-Lu. (more) 02/16/09

The group will focus on ve key areas, one being: enterprise collaboration and e-health.

Vodafone Foundation UN Foundation

The Foundations teamed up with the Rockefeller Foundation to create the mHealth Alliance. (more) 02/17/09

The mHealth Alliance aims to bring together the major mHealth stakeholders for the developing world.

MobilizeMRS FrontlineSMS

MobilizeMRS taps FrontlineSMS platform for its work in global health. (more) 02/24/09

MobilizeMRS rebranded to FrontlineSMS:Medic following the deal.

Ohio Health iShoeOhio Health pilots the smart innersole for fall prevention. (more) 02/26/09

Ohio Health expects iShoe to hit the market in 2010 with a pricepoint of $100.

Allscripts Edge HealthEdge Health to embed Allscript's EMR into its iPhone app, EdgeRPM. (more) 03/04/09

Allscripts launched its own iPhone app a few weeks later.

AllOne Health ClickatellClickatell enables text messaging for AllOne Mobile. (more) 03/11/09

AllOne Health's users in the Army look to be the rst to bene t.

AllOne Health

Signi ca Insurance Group and Erin Group Administrators

The health plans' members can view, manage and exchange their health info with their providers. (more) 03/16/09

The deals made AllOne Mobile available to more than 400,000 people total.

Rady Children's Hospital Given Imaging

Rady Children's pilots GI's Pillcam, a tiny wireless camera inside a pill. (more) 03/17/09

Joshua Devine, a high school sophomore, swallowed the Pillcam at Grady's – one of the rst patients to do so.

Telstra FoundationMurdoch Children's Research Institute

Telstra Foundation funded a two year mobile project for mental health services. (more) 03/25/09

The grant was for $285,000 Australian dollars.

Microsoft ANT Wireless

Microsoft to allow personal health devices to connect to HealthVault via ANT+. (more) 03/25/09

ANT+ is an alternative short range wireless technology to ZigBee or Bluetooth.

Gary and Mary West Foundation

Qualcomm, Scripps Health

GMWF donated $45M to create the West Wireless Health Institute. (more) 03/30/09

Qualcomm's Don Jones and Scripps' Dr. Eric Topol join as part of the Institute's founding board.

Page 26

http://mobihealthnews.com/439/interview-an-army-of-allone-mobile/

http://mobihealthnews.com/282/google-health-goes-mobile-on-android-iphone-soon/

http://mobihealthnews.com/298/kaiser-to-rollout-text-message-appointment-reminders/

http://mobihealthnews.com/338/ibm-continua-connect-google-health-to-mhealth-devices/

http://mobihealthnews.com/517/alcatel-lucent-develops-remote-patient-monitoring/

http://mobihealthnews.com/520/interview-un-vodafone-and-the-mhealth-alliance/

http://mobihealthnews.com/642/mobilizemrs-now-frontlinesmsmedic/

http://mobihealthnews.com/758/100-ishoe-due-out-next-year/

http://mobihealthnews.com/748/allscripps-to-enable-mobile-remote-practice-management/

http://mobihealthnews.com/856/clickatell-adds-text-msgs-to-allone-mobile/

http://mobihealthnews.com/924/allone-mobile-400000-pops-covered/

http://mobihealthnews.com/937/pillcam-now-used-at-rady-childrens-hospital/

http://mobihealthnews.com/1016/telstra-funds-mhealth-for-mental-health/

http://mobihealthnews.com/1027/microsoft-healthvault-to-connect-via-ant/

http://mobihealthnews.com/1082/45m-for-west-wireless-health-institute/



Verizon Wireless Alcatel-Lucent, Ericsson

Verizon Wireless launches 4G innovation center with Alcatel-Lucent and Ericsson. (more) 04/01/09

The center will focus on three key verticals: healthcare, utility and security.

Intel General Electric (GE)

Intel and GE announce partnership for home health monitoring and contribute $250 million to R&D. (more) 04/02/09

GE will market Intel's Health Guide as part of the deal, which also focuses on wireless sensors for the senior care market.

CardioNet BiotelCardioNet agrees to buy Biotel and enter clinical research. (more) 04/02/09 The deal eventually falls through.

GreatCall / Jitterbug Meridian Health, WellDoc

Jitterbug pilots a medication adherence service from Meridian and a diabetes management service from WellDoc. (more) 04/03/09

The services could become part of Jitterbug's Service Store – its version of an App Store.

MedApps Microsoft

RPM company MedApps connects devices' data streams to Microsoft's HealthVault. (more) 04/12/09

MedApps currently uses a dedicated wireless device to route data from connected medical devices.

Proteus BiomedicalTwo undisclosed pharma companies

Proteus announces two drug companies will trial its “intelligent medicine” technology and sensor. (more) 04/14/09

Later in the year, Novartis announces a trial with Proteus – unclear if it's a separate deal.

A.D.A.M.HelloHealth, Norton, LiveStrong, others

A.D.A.M. announces Medzio, a collaborative mobile app suite from the newly formed Mobile Health Network. (more) 04/21/09

Medzio continues to add a few new partners throughout the year, but the app's sum does not appear to be more popular than its parts.

Doylestown Hospital Apple

Doylestown Hospital becomes rst hospital pro led on Apple's site for equipping its care workers with iPhones throughout its facility. (more) 04/30/09

The hospital connected the iPhones to their Meditech EMR system and also noticed doctors favor Epocrates.

AT&TTexas Instruments, 24Eight

The three companies teamed up to work on smart innersoles for fall prevention. (more) 05/26/09

The collaboration results in AT&T's “smart slippers” for fall prevention, unveiled in December.

Jitterbug Samsung, Qualcomm

Senior phone service provider Jitterbug worked with phone maker Samsung on its new Jitterbug J phone and Qualcomm to create a more “seamless” data connectivity for users. The phone and data connectivity enable the company's Services Store. (more) 06/02/09

Jitterbug added 1xCDMA data to its phones but it didn't want the users to know they had Internet-enabled phones – perhaps too daunting.

Verizon Wireless LifeWatch

Remote cardiac monitoring company LifeWatch signed an exclusive agreement with Verizon to use its network to carry its wireless health services. (more) 06/04/09 LifeWatch is a big competitor to CardioNet.

White HouseVoxiva, CDC, J&J, CTIA, more

The White House is working with a number of industry partners to launch a free text messaging service, called Text4Baby, for low-income expectant mothers. (more) 06/05/09

Text4Baby originally aimed to launch in September but has since been delayed until next year.

Continua Health Alliance Nonin

Interoperability consortium Continua certi ed Nonin's Bluetooth-enabled pulse oximeter. (more) 06/09/09

This marks the rst wireless health device with Continua certi cation.

Partners Healthcare Connected Health

Partners Healthcare in Boston spun out a start-up, named Connected Health for now, with an initial service around a wireless blood pressure cu . (more) 06/16/09

Connected Health just completed a pilot with EMC, which used the cu for corporate wellness programs.

West Wireless Health Institute Corventis

The Institute announced plans to conduct clinical trials for Corventis and shepherd the sensor to market. (more) 06/23/09

Dr. Eric Topol and other Institute directors demo Corventis' monitoring sensor at events all year long.

Page 27

http://mobihealthnews.com/1112/ctia-verizon-on-mhealth-4g/

http://mobihealthnews.com/1139/its-official-intel-ge-partner-on-mhealth/

http://mobihealthnews.com/3241/no-deal-cardionet-cancels-biotel-acquisition/

http://mobihealthnews.com/1145/jitterbug-taps-welldoc-meridian-for-mhealth/

http://mobihealthnews.com/2166/medapps-connects-to-microsoft-healthvault/

http://mobihealthnews.com/1328/two-drug-companies-to-trial-proteus-this-year/

http://mobihealthnews.com/1522/adam-medzio-app-launches-for-iphone/

http://mobihealthnews.com/1781/doylestown-hospital-iphone-3g-for-physicians-staff/

http://mobihealthnews.com/2368/att-ti-team-up-for-wireless-balance-sensing/

http://mobihealthnews.com/4117/jitterbug-now-profitable-on-verizon-wireless-network/

http://mobihealthnews.com/2535/lifewatch-posts-up-against-cardionet-with-verizon-deal/

http://mobihealthnews.com/2543/voxiva-cdc-white-house-to-launch-text4baby/

http://mobihealthnews.com/2638/interop-has-a-health-at-least/

http://mobihealthnews.com/2722/partners-spins-out-wireless-health-start-up/

http://mobihealthnews.com/2897/west-wireless-health-institute-to-conduct-corventis-trial/



Roche Diagnostics MYLEstone Health

Roche inked a deal with diabetes app developer MYLEstone Health to include some of Roche's diabetes management software into the company's Glucose Buddy application. (more) 07/01/09

MYLEstone saw the deal as a baby step for the industry and was fed up with hype around meter integration into smartphones.

WellAware

Evangelical Lutheran Good Samaritan Society, Hastin

WellAware to out t the outpatient centers with wireless sensors for senior care. (more) 07/01/09

WellAware only launched a few weeks before the announcement.

Healthagen / iTriage Centura Health

Centura Health signed on as the rst sponsored listing in Healthagen's iTriage smartphone application. (more) 07/08/09

Healthagen's iTriage helps users determine wait times at hospitals.

Highmark CMS CardioNet

Highmark CMS slashed CardioNet's reimbursement rate by one third. (more) 07/13/09

The move followed months of rumors and sent the company's stock plummeting.

Modavox Augme Mobile

Modavox bought Augme Mobile, a mobile marketing company for an undisclosed sum. (more) 07/15/09

Augme Mobile Health is the start-up's wireless health focused marketing arm. Quickly becomes a focus at Modavox.

Bayer Healthcare Nintendo

Bayer created “Didget” a blood glucose meter that plugs into Nintendo DS portable game system. (more) 07/16/09

The peripheral could spark a healthy games movement.

CallMD A.D.A.M.CallMD joins A.D.A.M.'s Medzio Mobile Health Network. (more) 07/17/09

CallMD will license A.D.A.M. Symptom navigator content, too.

Department of Veterans A airs mVisum

The pilot involves getting physicians access to patient data while they are on their way to the bedside. (more) 07/21/09

The pilot became public after the VA announced it would tighten the belt on pilot spending.

Skyscape Physicians Interactive

Digital sales and health marketing company Physicians Interactive (PI) acquired mobile medical content publisher Skyscape for an undisclosed sum. (more) 07/27/09

Skyscape has long created mobile applications for healthcare workers dating back to PDAs.

Verizon Wireless Qualcomm

Verizon Wireless and Qualcomm form a joint venture called nPhase to manage machine-to-machine services, including many wireless health o erings. 07/28/09

nPhase also took over managing CardioNet's service as part of the deal.

St. Francis Hospital St. Jude Medical

Patient at the hospital is rst to receive wireless-enabled, remote monitoring pace maker. (more) 08/10/09

The pacemaker connects to the server at least once a day to make reports.

Page 28

http://mobihealthnews.com/2969/glucose-buddy-inks-app-deal-with-roche/

http://mobihealthnews.com/3023/wireless-sensors-for-two-faith-based-nursing-facilities/

http://mobihealthnews.com/3081/healthagen-reveals-true-monetization-strategy/

http://mobihealthnews.com/3497/cardionet-announces-highmark-medicare-services-reimbursement-reduction/

http://mobihealthnews.com/3247/modavox-buys-newly-formed-mhealth-marketing-co/

http://mobihealthnews.com/3135/shorts-bayer-nintendo-kaiser-permanente-and-more/

http://mobihealthnews.com/3293/callmd-joins-adams-mobile-health-network/

http://mobihealthnews.com/3329/va-mvisum-conduct-mobile-ekg-pilot/

http://mobihealthnews.com/3457/pi-buys-skyscape/

Joe

Typewritten Text

Joe

Typewritten Text

Joe

Typewritten Text

http://mobihealthnews.com/3533/verizon-wireless-qualcomm-form-m2m-joint-venture/

http://mobihealthnews.com/3770/first-patient-for-st-jude-medicals-wireless-pacemaker/



Best Buy Microsoft

The store chain teamed up with Microsoft to invite wireless health device makers to pitch it to carry their products. (more) 08/20/09

Best Buy launched tness sections at its stores with some connected health products a few months later.

Verizon Wireless Panasonic

Verizon Wireless certi ed Panasonic's Toughbook H1 to run on its network. (more) 08/27/09

The H1 was speci cally designed for clinicians and based on extensive research conducted by Intel and Panasonic.

Verizon Wireless GreatCall / JitterbugJitterbug switched over to Verizon Wireless' network from Sprint. (more) 08/27/09

Jitterbug also announced it was now pro table.

Harvard Pilgrim Health Care MedMinder

Harvard Pilgrim will pilot MedMinder's wireless-enabled PillBox for CKD patients. (more) 08/31/09

Chronic kidney disease a ects about 26 million people and has no cure, but it can be managed.

Sprint DataSmart

The carrier is working with the M2M company to accelerate time to market for healthcare services and connected devices. (more) 09/03/09

According to one estimate: 430 million M2M devices will ship in 2013

Halo Monitoring Microsoft

Halo's myHalo wireless monitoring o ering now synchs to Microsoft HealthVault. (more) 09/09/09

myHalo wirelessly transmits secure vital signs, activities of daily living, and critical event info.

Novartis Proteus Biomedical

Novartis has tapped Proteus for a small, 20 patient study to track compliance with a blood pressure drug regimen. (more) 09/22/09

Novartis told reporters (inexplicably) that the deal could become exclusive.

Methodist Healthcare GE, Sprint

GE and Sprint installed a converged wireless network at the company's six hospitals. (more) 09/23/09

Methodist may hire more nurses thanks to the savings from the network, reportedly.

AirStripPremier Healthcare Alliance

AirStrip inked a purchasing agreement with the alliance, which has 2,200 hospital members. (more) 09/29/09

AirStrip had more than 100 customers at the time.

DeviceAnywhereEosHealth, StratREF, Sensei

DeviceAnywhere tests the wireless health service's for QoS. (more) 09/30/09

DA noted an uptick in wireless health services looking to test QoS in 2009.

Continued

Page 29

http://mobihealthnews.com/3995/best-buy-eyes-wireless-health-opportunity/

http://mobihealthnews.com/4104/by-any-other-name/

http://mobihealthnews.com/4117/jitterbug-now-profitable-on-verizon-wireless-network/

http://mobihealthnews.com/4153/harvard-pilgrim-to-pilot-wireless-pillbox-for-ckd-patients/

http://mobihealthnews.com/4225/sprint-and-m2m-datasmart-make-it-easier-to-bring-an-embedded-device-to-market/

http://mobihealthnews.com/4302/halo-monitoring-synchs-to-microsofts-healthvault/

http://mobihealthnews.com/4513/novartis-proteus-pilot-to-lead-to-exclusive-deal/

http://mobihealthnews.com/4522/methodist-healthcare-wireless-network-means-more-nurses/

http://mobihealthnews.com/4615/airstrip-inks-deal-with-premier-healthcare-alliance/

http://mobihealthnews.com/4640/mobile-app-qos-company-notes-uptick-in-healthcare/



Keas Microsoft, Google, othersFormer Google Health head launches online health site Keas. (more) 10/06/09

Keas is a care program store – care professionals design care plans for consumers to buy.

Verizon Wireless Xora

VZW o ers home health care workers application called OnCare, which was created by Xora. (more) 10/08/09 The app costs about $35 a month.

Sarasota Memorial Hospital Voalte

Voalte's iPhone-enabled voice, alarm, text service is piloted at Sarasota Memorial Hospital. (more) 10/08/09

Voalte becomes a hit with nurses there, looks to move to other wards.

AT&T Vitality

AT&T will provide connectivity for Vitality's GlowCaps medication adherence device. (more) 10/09/09

GlowCaps light up when a patient needs to take medication, send texts and can even call the pharmacy for re lls.

Corventis USC

USC develops an iPhone game called BeatingHeart, that demonstrates Corventis' wireless sensor capabilities. (more) 10/14/09

While just a concept app, it could point to opportunities for health games with sensors.

Apple Epic Systems

Apple teams up with Epic Systems to integrate iPhones into Epic's EMR o ering at Stanford Hospital and Clinics. (more) 10/14/09 Expect a full product launch in early 2010.

Cinterion Wireless Modules Diabetech

Cinterion powers connectivity for Diabetech's 4th generation wireless diabetes management platform, GlucoMON. (more) 10/15/09

Diabetes is a key condition targeted by many wireless health start-ups.

Boston Scienti c USC

USC and Boston Scienti c created a demo iPhone app for BS's Latitude application. (more) 10/23/09

Latitude enables physicians to monitor implanted devices.

Motorola Vocera

The two companies create a smartphone speci cally for hospital workers called the Vocera Smartphone. (more) 10/27/09

Arkansas Children's Hospital was a beta user for the device.

AllOne Health Connectyx

AllOne Mobile will be packaged with health info on a USB drive company, Connectyx's MediFlash o ering. (more) 11/02/09

The deal puts AOM in Walgreens, Harris Teeter, Krogers and other retail locations.

St. Mary's Hospital Toumaz Holdings

London-based St. Mary's Hospital will trial Toumaz's wireless sensor for vital sign monitoring. (more) 11/02/09

The bandaid-like sensor monitors skin temperature, heart rate and respiration.

Page 30

http://mobihealthnews.com/4747/former-google-health-head-launches-keas/

http://mobihealthnews.com/4806/verizon-wireless-offers-home-health-care-workers-app/

http://mobihealthnews.com/4798/voalte-announces-pilot-results-from-sarasota-memorial/

http://mobihealthnews.com/4839/att-inks-deal-to-provide-connectivity-for-glowcaps/

http://mobihealthnews.com/4883/corventis-usc-create-concept-beating-heart-mobile-game/

http://mobihealthnews.com/4952/apple-epic-team-up-for-mobile-ehr-pilot/

http://mobihealthnews.com/4873/shorts-google-wave-itriage-diabetech/

http://mobihealthnews.com/5064/boston-scientifics-concept-iphone-app-latitude/

http://mobihealthnews.com/5101/vocera-motorola-create-smartphone-for-hospitals/

http://mobihealthnews.com/5243/allone-mobile-goes-retail-walgreens-harris-teeter/

http://mobihealthnews.com/5224/toumaz-carefusion-trial-sensor-at-st-marys-hospital/


Continued


Roche Diagnostics NeuroVigil

Roche will pilot NeurVigil's iBrain wireless sensors for clinical trials involving CNS disorders. (more) 11/02/09

NeuroVigil's iBrain captures the user's brain's EEG signals wirelessly.

GreatCall / Jitterbug MobiWatch

Jitterbug acquired mobile personal emergency response service (MPERS) start-up MobiWatch for an undisclosed sum. (more) 11/04/09

Jitterbug plans to integrate the MPERS into its phones for now – no external medallion.

Mount Sinai Hospital CareSpeak

Mount Sinai tested CareSpeak's text messaging adherence program for teenage liver transplant patients. (more) 11/05/09

The program remarkably reduced rejection episodes for the patients.

Mayo Clinic STMicroelectronics

Mayo and STM are collaborating on a wireless cardiac monitoring service. (more) 11/05/09

The system will monitor heart rate, breathing rate, and physical activity.

GSM Association University of Manchester

GSMA and the university plan to establish a wireless health innovation center in Manchester. (more) 11/11/09 It will have a UK-focus in the beginning.

Research In Motion / BlackBerry MedAptus

Research In Motion has brought MedAptus, a charge capture o ering for physicians, to its BlackBerry devices. (more) 11/19/09

MedAptus brought three versions of its o ering to BlackBerry.

AT&T, HTCWound Technology Network

Remote wound care service WTN inked a two year agreement with AT&T for connectivity. It also inked a deal with HTC to use the Fuze smartphone. (more) 11/23/09

WTN uses wireless networks to access patient records, review visuals and more. WTN used to work through Verizon Wireless.

IntelVA, Memorial Hospital & Health System, others

Intel announced a number of Indiana-based customers for its Intel Health Guide device for the home health market. (more) 11/24/09

The Health Guide added wireless connectivity this year.

Johns Hopkins School of Nursing Intel, Clearwire

Intel is piloting its Intel Health Guide at JH School of Nursing. (more) 11/30/09

The devices will run on Clearwire's new WiMAX network in Baltimore.

GELiving Independently Group

GE bought LIG for an undisclosed amount. LIG's o ering QuietCare uses infrared sensors to remotely monitor patients in senior care facilities. (more) 12/02/09

GE owned a minority stake in LIG prior to the acquisition.

Novartis IBM, Vodafone

Novartis is working with IBM and Vodafone to bring SMS For Life campaign to Tanzania. (more) 12/14/09

The service aims to improve availability of anti-malarial drugs in remote areas.

Page 31

http://mobihealthnews.com/5215/roche-inks-deal-with-sleep-monitoring-start-up/

http://mobihealthnews.com/5294/jitterbug-scoops-up-m-pers-start-up-mobiwatch/

http://mobihealthnews.com/5329/mt-sinai-carespeak-text-liver-transplant-patients/

http://mobihealthnews.com/5325/mayo-clinic-stm-developing-wireless-cardiac-monitor/

http://mobihealthnews.com/5448/gsma-to-establish-mhealth-innovation-center/

http://mobihealthnews.com/5537/medaptus-brings-charge-capture-to-blackberry/

http://mobihealthnews.com/5551/wound-tech-taps-att-htc-fuze-smartphones/

http://mobihealthnews.com/5577/intel-health-guide-lands-varied-customer-base/

http://mobihealthnews.com/5599/johns-hopkins-intel-test-health-guides-on-wimax/

http://mobihealthnews.com/5636/ge-buys-elder-care-remote-monitoring-start-up/

http://mobihealthnews.com/5786/ibm-novartis-vodafone-launch-sms-for-life/

FDA may regulate certain mobile phones, accessories

By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.

It can come as a bit of a shock to people in the consumer electronics, IT and telecommunications industries that FDA might regulate certain equipment like cell phones that companies are plan-ning to put at the center of connected health services. My goal is to outline the factors that FDA considers when deciding whether to regulate such equipment.

Defining a medical device

The natural place to start is with the definition of a medical device. Since it is so central to the analysis, I’m going to quote the statute verbatim. Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:

“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either] intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treat-ment, or prevention of disease, in man or other animals … [or] intended to affect the structure or any function of the body of man or other animals.”

So 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.

Continued Online: http://mobihealthnews.com/3177/fda-may-regulate-certain-mobile-phones-accessories/

Step-by-step: FDA wireless health regulation

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 regula-tions. Each of those regulations has a description or “identification” of the types of devices

A Step-By-Step How-to for Wireless Health Regulation


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 regu-lations 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 wire-lessly 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.

Step two. Read the second half of the classification regulation to see how FDA regulates that particular article.

FDA will assign each product into one of three classifications, cleverly called class I, II and III. Class I devices represent the least risk, while class III represent the greatest. Associated with those classifications are specific regulatory requirements. Many class I devices will be exempt from premarket clearance, and some products will be exempt from other regulatory requirements that I’ll describe in a minute. Some class I and most class II devices require filing a premarket noti-fication (or 510(k)) with FDA. These submissions are manageable documents that compare the new device to those lawfully on the market. The specific data requirements are discuss below.

The highest risk devices-class III-usually require premarket approval (PMA) from FDA, which can cost millions. Most IT devices can avoid that, unless they are an accessory to a high risk device. If your device is classified as an accessory, it is subject to all of the regulatory requirements appli-cable to the parent device.

Step three. Research the requirements.

FDA has published scads of guidance documents on its website that cover many different aspects of the technologies they regulate. There are guidance documents on using wireless technologies, off-the-shelf software, and specific medical technologies such as blood glucose meters. It’s important you find all of these so-called “special controls” because you’ll need to make sure that your product complies with those technical standards.



Steps Four and Five Continued Online: http://mobihealthnews.com/4050/step-by-step-fda-wireless-health-regulation/

How to get FDA to clear a mobile health app

It’s important to remember that medical devices, including software, can be divided into three categories: (1) standalone devices, (2) accessories and (3) components. Standalone are those devices that are intended to directly provide the diagnostic or treatment, while accessories are sold directly to end-users and work with standalone devices. Components, in contrast, are purchased by manufacturers of standalone or accessory devices for incorporation before sale. Mobile device (e.g. cell phone apps) can be an accessory, as opposed to a component, if they are sold or even given directly to the end-user: the patient. They can also be standalone if they do not connect physically or virtually to any device other than the mobile device platform.

Understanding that is important because determines the regulatory requirements that apply. If the app is designed, for example, to facilitate the downloading of information from a blood glucose meter, the app and maybe even the software environment are accessories and will be regulated in the same manner as the blood glucose meter. The classification and most of the requirements for the submission to FDA will be dictated by how the parent standalone device is regulated. So, the Airstrip OB app is regulated as part of a perinatal monitoring system generally, just as the sensors and other hardware that gather the information.

Some apps will not be simply enablers of transmitting data from a medical device, but will actu-ally serve a standalone purpose. From the prior two articles, remember that it’s the claims the software developer/seller choose to make, within reason, that triggers FDA regulation in the first place, and the degree of that regulation when it comes to obtaining clearance.

Continued Online: http://mobihealthnews.com/5626/how-to-get-fda-to-clear-a-mobile-health-app/



The Year in Conclusion

While this report could not discuss every deal or development in wireless health this past year, it should serve as a reference point for the year ahead as well as a snapshot of an industry in its infancy. Next year will bring substantial revenue growth for the industry, increased capital invest-ment, a number of strategic acquisitions and little progress on reimbursement from payers.

Many wireless carriers only recently established dedicated healthcare business units, which may begin to launch products by the end of next year. Some of the newly founded institute's are working to fill leadership, while others were only founded a few weeks ago. Care provider groups are largely experimenting with pilots and looking for signs of efficacy from budding wireless health services. Direct to consumer health products are mostly only available via online stores, but the big box electronics stores are beginning to take notice.

These are still early days, but they are busy ones.


The Year inConclusion

Date post:	05-Dec-2014
Category:	Documents
Upload:	wirehead-technology
View:	1,161 times
Download:	1 times

2009 State Of The Industry

Documents