2009 State Of The Industry

WIRELESS HEALTH:
STATE OF THE INDUSTRY
2009 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

Publisher’s Note
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 Maillie
Publisher, Co-Founder
MobiHealthNews

Letter from the Editor
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 Dolan
Editor & Co-Founder
MobiHealthNews

State of the Industry Page 1

Industry Metrics: Wireless Health By the Numbers
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

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.


Carriers Take the Lead on Wireless Health
“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

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.

Care Providers Push Pilots, Look for Results
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

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.


Alliances and Institutes Accelerate Time to Market
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.


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.


Reimbursement Rises and Falls
“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.


Consumer Health: The Answer to "Who Pays?"

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.”


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.


Venture
Capital 2009
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.


Venture
Capital 2009
Date
Company Amount Location Announced Investors Company Description
Arcapita Ventures, Boston Developer of implantable wireless sensors that
Millennium, Foundation track cardiac output, blood pressure and heart
CardioMEMS $22.1 million Atlanta, GA 08/26/09 Medical rate (more)
Lead Investor: InterWest
Partners; Also: Kleiner Perkins
Autonomic Cau eld & Byers, The Developer of implantable devices that aim to
Technologies $20 million Menlo Park, CA 05/08/09 Cleveland Clinic soothe severe headaches (more)
Lead Investor: BlueCross
BlueShield Venture Partners;
Also: Polaris Venture Partners, Developer of an automatic patient check-in
HLM Venture Partners and device and service that aims to improve patient-
Phreesia $11.6 million New York, NY 02/20/09 Long River Ventures provider relationship (more)
Lead Investor: Seventure
Partners; Also: ePlanet, Developer of wireless monitoring devices,
Enterprise Ireland, and including a motion sensor that detects heart rate
BiancaMed $9.8 million Belfast, Ireland 07/20/09 ResMed and respiration (more)
Lead Investor: HLM Venture National network of primary care physicians that
TelaDoc Partners; Also: Cardinal diagnose illness, recommend treatment, and
Medical Services $9 million Dallas, TX 12/04/09 Partners, Trident Capital prescribe medication over the phone (more)
Developer of wireless remote monitoring systems
Valhalla Partners, .406 that track the daily activities of cared for
WellAware $7.5 million Charlottesville, VA 12/08/09 Ventures. individuals in the home (more)
MycaHub combines an EMR, a comprehensive
admin system, and the ability for doctors to
BlueCross BlueShield Venture communicate with their patients via a variety of
Myca Health $5 million San Francisco, CA 10/06/09 Partners, Sandbox Industries. channels. (more)
Investors include Cotswold Echo is developing a wireless blood glucose
Echo Therapeutics $3.6 million Franklin, MA 12/04/09 Foundation monitor for diabetics.
BL's platform, TVx, gathers info from Bluetooth-
based wireless medical devices at home and
BL Healthcare $3 million Foxborough, MA 08/06/09 undisclosed displays it on the TV.
Lead Investor: PUK Ventures;
Also: Catapult Venture Developer of wireless technology for monitoring
Managers, University of the health of expectant mothers and babies
Monica Healthcare $1.6 million Nottingham, UK 04/27/09 Nottingham (more)
Carilion Biomedical Institute, Developer of medical applications for wireless
Wireless Medcare $535K Roanoke, VA 12/11/09 Optimum Sensor Holdings and web-enabled devices (more)
Developer of motion-detecting iPhone tness
apps that include peer challenges to keep users
GymFu $160K Hampshire, UK 12/01/09 Lead Investor: Channel 4's 4iP motivated
eCardio Service provider of remote cardiac monitoring for
Diagnostics undisclosed The Woodlands, TX 07/01/09 Sequoia Capital arrhythmia diagnosis (more)
Developer of a personalized online tness
New Venture Partners, coaching system and wireless monitoring device
MiLife undisclosed Bedford, UK 01/16/09 Unilever Ventures (more)
Developer of real-time physiological and
biomechanical monitoring technology for
defense, rst responder, training and research
Zephyr Technology undisclosed Annapolis, MD 06/18/09 Motorola Ventures markets (more)

Page 24

2009
Wirelss
Health
Deals

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.

Page 25

Q1
Wirelss
Health
Deals

Date
Company A Company B, etc. What was the deal? Announced Other details?
Army to pilot AllOne Mobile to stay in Army licensed the technology for 10,000
touch with “wounded warriors” soldiers, speci cally those with traumatic
U.S. Army AllOne Health, Diversinet through their mobiles. (more) 01/14/09 brain injuries.
The Mobile Viewer allows users to view but
not edit pro le information as well as
Anvita developed a mobile viewer of current prescriptions, existing health
Google Anvita Mobile Google Health for Android. (more) 02/05/09 conditions, known allergies and more.
KP worked with Mobilestorm for the pilot,
Completed a pilot for text message which showed 0.73 fewer “no shows.”
Kaiser Permanente Mobilestorm appointment reminders. (more) 02/05/09 National rollout to follow.
As part of the announcement, IBM said it
IBM and Continua to create had integrated its Information
guidelines for wireless medical Management, Business Intelligence and
Continua Health Alliance, devices to connect to Google Health. WebSphere Premises Server sensor event
IBM Google (more) 02/12/09 platform into Google Health already.
Companies formed, ng Connect, a
group for vendors looking to create The group will focus on ve key areas, one
Motorola, HP, Samsung, next-gen wireless devices with Alca- being: enterprise collaboration and e-
Alcatel-Lucent others Lu. (more) 02/16/09 health.
The Foundations teamed up with the The mHealth Alliance aims to bring
Rockefeller Foundation to create the together the major mHealth stakeholders
Vodafone Foundation UN Foundation mHealth Alliance. (more) 02/17/09 for the developing world.
MobilizeMRS taps FrontlineSMS
platform for its work in global health. MobilizeMRS rebranded to
MobilizeMRS FrontlineSMS (more) 02/24/09 FrontlineSMS:Medic following the deal.
Ohio Health pilots the smart Ohio Health expects iShoe to hit the
Ohio Health iShoe innersole for fall prevention. (more) 02/26/09 market in 2010 with a pricepoint of $100.

Edge Health to embed Allscript's EMR Allscripts launched its own iPhone app a
Allscripts Edge Health into its iPhone app, EdgeRPM. (more) 03/04/09 few weeks later.
Clickatell enables text messaging for AllOne Health's users in the Army look to
AllOne Health Clickatell AllOne Mobile. (more) 03/11/09 be the rst to bene t.

Signi ca Insurance Group The health plans' members can view,
and Erin Group manage and exchange their health The deals made AllOne Mobile available to
AllOne Health Administrators info with their providers. (more) 03/16/09 more than 400,000 people total.
Rady Children's pilots GI's Pillcam, a Joshua Devine, a high school sophomore,
tiny wireless camera inside a pill. swallowed the Pillcam at Grady's – one of
Rady Children's Hospital Given Imaging (more) 03/17/09 the rst patients to do so.
Telstra Foundation funded a two year
Murdoch Children's mobile project for mental health The grant was for $285,000 Australian
Telstra Foundation Research Institute services. (more) 03/25/09 dollars.
Microsoft to allow personal health
devices to connect to HealthVault via ANT+ is an alternative short range wireless
Microsoft ANT Wireless ANT+. (more) 03/25/09 technology to ZigBee or Bluetooth.
Qualcomm's Don Jones and Scripps' Dr.
Gary and Mary West Qualcomm, Scripps GMWF donated $45M to create the Eric Topol join as part of the Institute's
Foundation Health West Wireless Health Institute. (more) 03/30/09 founding board.

Page 26

Q2
Wirelss
Health
Deals
Date
Verizon Wireless launches 4G
innovation center with Alcatel-Lucent The center will focus on three key verticals:
Verizon Wireless Alcatel-Lucent, Ericsson and Ericsson. (more) 04/01/09 healthcare, utility and security.
Intel and GE announce partnership
for home health monitoring and GE will market Intel's Health Guide as part
contribute $250 million to R&D. of the deal, which also focuses on wireless
Intel General Electric (GE) (more) 04/02/09 sensors for the senior care market.
CardioNet agrees to buy Biotel and
CardioNet Biotel enter clinical research. (more) 04/02/09 The deal eventually falls through.
Jitterbug pilots a medication
adherence service from Meridian and The services could become part of
a diabetes management service from Jitterbug's Service Store – its version of an
GreatCall / Jitterbug Meridian Health, WellDoc WellDoc. (more) 04/03/09 App Store.
RPM company MedApps connects MedApps currently uses a dedicated
devices' data streams to Microsoft's wireless device to route data from
MedApps Microsoft HealthVault. (more) 04/12/09 connected medical devices.
Proteus announces two drug
companies will trial its “intelligent Later in the year, Novartis announces a trial
Two undisclosed pharma medicine” technology and sensor. with Proteus – unclear if it's a separate
Proteus Biomedical companies (more) 04/14/09 deal.
A.D.A.M. announces Medzio, a Medzio continues to add a few new
collaborative mobile app suite from partners throughout the year, but the
HelloHealth, Norton, the newly formed Mobile Health app's sum does not appear to be more
A.D.A.M. LiveStrong, others Network. (more) 04/21/09 popular than its parts.
Doylestown Hospital becomes rst
hospital pro led on Apple's site for
equipping its care workers with The hospital connected the iPhones to
iPhones throughout its facility. their Meditech EMR system and also
Doylestown Hospital Apple (more) 04/30/09 noticed doctors favor Epocrates.
The three companies teamed up to The collaboration results in AT&T's “smart
Texas Instruments, work on smart innersoles for fall slippers” for fall prevention, unveiled in
AT&T 24Eight prevention. (more) 05/26/09 December.
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 Jitterbug added 1xCDMA data to its
users. The phone and data phones but it didn't want the users to
connectivity enable the company's know they had Internet-enabled phones –
Jitterbug Samsung, Qualcomm Services Store. (more) 06/02/09 perhaps too daunting.
Remote cardiac monitoring company
LifeWatch signed an exclusive
agreement with Verizon to use its
network to carry its wireless health
Verizon Wireless LifeWatch services. (more) 06/04/09 LifeWatch is a big competitor to CardioNet.
The White House is working with a
number of industry partners to
launch a free text messaging service, Text4Baby originally aimed to launch in
Voxiva, CDC, J&J, CTIA, called Text4Baby, for low-income September but has since been delayed
White House more expectant mothers. (more) 06/05/09 until next year.
Interoperability consortium Continua
certi ed Nonin's Bluetooth-enabled This marks the rst wireless health device
Continua Health Alliance Nonin pulse oximeter. (more) 06/09/09 with Continua certi cation.
Partners Healthcare in Boston spun
out a start-up, named Connected
Health for now, with an initial service Connected Health just completed a pilot
around a wireless blood pressure cu . with EMC, which used the cu for
Partners Healthcare Connected Health (more) 06/16/09 corporate wellness programs.
The Institute announced plans to
conduct clinical trials for Corventis Dr. Eric Topol and other Institute directors
West Wireless Health and shepherd the sensor to market. demo Corventis' monitoring sensor at
Institute Corventis (more) 06/23/09 events all year long.

Page 27

Q3
Wirelss
Health
Deals

Date
Roche inked a deal with diabetes app
developer MYLEstone Health to
include some of Roche's diabetes MYLEstone saw the deal as a baby step for
management software into the the industry and was fed up with hype
company's Glucose Buddy around meter integration into
Roche Diagnostics MYLEstone Health application. (more) 07/01/09 smartphones.
Evangelical Lutheran WellAware to out t the outpatient
Good Samaritan Society, centers with wireless sensors for WellAware only launched a few weeks
WellAware Hastin senior care. (more) 07/01/09 before the announcement.
Centura Health signed on as the rst
sponsored listing in Healthagen's
iTriage smartphone application. Healthagen's iTriage helps users determine
Healthagen / iTriage Centura Health (more) 07/08/09 wait times at hospitals.
Highmark CMS slashed CardioNet's
reimbursement rate by one third. The move followed months of rumors and
Highmark CMS CardioNet (more) 07/13/09 sent the company's stock plummeting.
Modavox bought Augme Mobile, a Augme Mobile Health is the start-up's
mobile marketing company for an wireless health focused marketing arm.
Modavox Augme Mobile undisclosed sum. (more) 07/15/09 Quickly becomes a focus at Modavox.
Bayer created “Didget” a blood
glucose meter that plugs into
Nintendo DS portable game system. The peripheral could spark a healthy
Bayer Healthcare Nintendo (more) 07/16/09 games movement.
CallMD joins A.D.A.M.'s Medzio CallMD will license A.D.A.M. Symptom
CallMD A.D.A.M. Mobile Health Network. (more) 07/17/09 navigator content, too.
The pilot involves getting physicians The pilot became public after the VA
Department of Veterans access to patient data while they are announced it would tighten the belt on
A airs mVisum on their way to the bedside. (more) 07/21/09 pilot spending.
Digital sales and health marketing
company Physicians Interactive (PI)
acquired mobile medical content Skyscape has long created mobile
publisher Skyscape for an applications for healthcare workers dating
Skyscape Physicians Interactive undisclosed sum. (more) 07/27/09 back to PDAs.
Verizon Wireless and Qualcomm form
a joint venture called nPhase to
manage machine-to-machine
services, including many wireless nPhase also took over managing
Verizon Wireless Qualcomm health o erings. 07/28/09 CardioNet's service as part of the deal.
Patient at the hospital is rst to
receive wireless-enabled, remote The pacemaker connects to the server at
St. Francis Hospital St. Jude Medical monitoring pace maker. (more) 08/10/09 least once a day to make reports.

Page 28

Q3
Wirelss
Health
Deals
Continued

Date
The store chain teamed up with
Microsoft to invite wireless health Best Buy launched tness sections at its
device makers to pitch it to carry their stores with some connected health
Best Buy Microsoft products. (more) 08/20/09 products a few months later.
Verizon Wireless certi ed Panasonic's The H1 was speci cally designed for
Toughbook H1 to run on its network. clinicians and based on extensive research
Verizon Wireless Panasonic (more) 08/27/09 conducted by Intel and Panasonic.
Jitterbug switched over to Verizon Jitterbug also announced it was now
Verizon Wireless GreatCall / Jitterbug Wireless' network from Sprint. (more) 08/27/09 pro table.
Harvard Pilgrim will pilot Chronic kidney disease a ects about 26
Harvard Pilgrim Health MedMinder's wireless-enabled PillBox million people and has no cure, but it can
Care MedMinder for CKD patients. (more) 08/31/09 be managed.
The carrier is working with the M2M
company to accelerate time to
market for healthcare services and According to one estimate: 430 million
Sprint DataSmart connected devices. (more) 09/03/09 M2M devices will ship in 2013
Halo's myHalo wireless monitoring myHalo wirelessly transmits secure vital
o ering now synchs to Microsoft signs, activities of daily living, and critical
Halo Monitoring Microsoft HealthVault. (more) 09/09/09 event info.
Novartis has tapped Proteus for a
small, 20 patient study to track
compliance with a blood pressure Novartis told reporters (inexplicably) that
Novartis Proteus Biomedical drug regimen. (more) 09/22/09 the deal could become exclusive.
GE and Sprint installed a converged
wireless network at the company's six Methodist may hire more nurses thanks to
Methodist Healthcare GE, Sprint hospitals. (more) 09/23/09 the savings from the network, reportedly.
AirStrip inked a purchasing
Premier Healthcare agreement with the alliance, which AirStrip had more than 100 customers at
AirStrip Alliance has 2,200 hospital members. (more) 09/29/09 the time.
EosHealth, StratREF, DeviceAnywhere tests the wireless DA noted an uptick in wireless health
DeviceAnywhere Sensei health service's for QoS. (more) 09/30/09 services looking to test QoS in 2009.

Page 29

Q4
Wirelss
Health
Deals

Date
Keas is a care program store – care
Former Google Health head launches professionals design care plans for
Keas Microsoft, Google, others online health site Keas. (more) 10/06/09 consumers to buy.
VZW o ers home health care workers
application called OnCare, which was
Verizon Wireless Xora created by Xora. (more) 10/08/09 The app costs about $35 a month.
Voalte's iPhone-enabled voice, alarm,
Sarasota Memorial text service is piloted at Sarasota Voalte becomes a hit with nurses there,
Hospital Voalte Memorial Hospital. (more) 10/08/09 looks to move to other wards.
AT&T will provide connectivity for GlowCaps light up when a patient needs to
Vitality's GlowCaps medication take medication, send texts and can even
AT&T Vitality adherence device. (more) 10/09/09 call the pharmacy for re lls.
USC develops an iPhone game called
BeatingHeart, that demonstrates While just a concept app, it could point to
Corventis' wireless sensor capabilities. opportunities for health games with
Corventis USC (more) 10/14/09 sensors.
Apple teams up with Epic Systems to
integrate iPhones into Epic's EMR
o ering at Stanford Hospital and
Apple Epic Systems Clinics. (more) 10/14/09 Expect a full product launch in early 2010.
Cinterion powers connectivity for
Diabetech's 4th generation wireless
Cinterion Wireless diabetes management platform, Diabetes is a key condition targeted by
Modules Diabetech GlucoMON. (more) 10/15/09 many wireless health start-ups.
USC and Boston Scienti c created a
demo iPhone app for BS's Latitude Latitude enables physicians to monitor
Boston Scienti c USC application. (more) 10/23/09 implanted devices.
The two companies create a
smartphone speci cally for hospital
workers called the Vocera Arkansas Children's Hospital was a beta
Motorola Vocera Smartphone. (more) 10/27/09 user for the device.
AllOne Mobile will be packaged with
health info on a USB drive company,
Connectyx's MediFlash o ering. The deal puts AOM in Walgreens, Harris
AllOne Health Connectyx (more) 11/02/09 Teeter, Krogers and other retail locations.
London-based St. Mary's Hospital will
trial Toumaz's wireless sensor for vital The bandaid-like sensor monitors skin
St. Mary's Hospital Toumaz Holdings sign monitoring. (more) 11/02/09 temperature, heart rate and respiration.

Page 30

Q4
Wirelss
Health
Deals
Continued

Date
Roche will pilot NeurVigil's iBrain
wireless sensors for clinical trials NeuroVigil's iBrain captures the user's
Roche Diagnostics NeuroVigil involving CNS disorders. (more) 11/02/09 brain's EEG signals wirelessly.
Jitterbug acquired mobile personal
emergency response service (MPERS) Jitterbug plans to integrate the MPERS into
start-up MobiWatch for an its phones for now – no external
GreatCall / Jitterbug MobiWatch undisclosed sum. (more) 11/04/09 medallion.
Mount Sinai tested CareSpeak's text
messaging adherence program for
teenage liver transplant patients. The program remarkably reduced rejection
Mount Sinai Hospital CareSpeak (more) 11/05/09 episodes for the patients.
Mayo and STM are collaborating on a
wireless cardiac monitoring service. The system will monitor heart rate,
Mayo Clinic STMicroelectronics (more) 11/05/09 breathing rate, and physical activity.
GSMA and the university plan to
establish a wireless health innovation
GSM Association University of Manchester center in Manchester. (more) 11/11/09 It will have a UK-focus in the beginning.
Research In Motion has brought
MedAptus, a charge capture o ering
Research In Motion / for physicians, to its BlackBerry MedAptus brought three versions of its
BlackBerry MedAptus devices. (more) 11/19/09 o ering to BlackBerry.
Remote wound care service WTN
inked a two year agreement with WTN uses wireless networks to access
AT&T for connectivity. It also inked a patient records, review visuals and more.
Wound Technology deal with HTC to use the Fuze WTN used to work through Verizon
AT&T, HTC Network smartphone. (more) 11/23/09 Wireless.
Intel announced a number of Indiana-
based customers for its Intel Health
VA, Memorial Hospital & Guide device for the home health The Health Guide added wireless
Intel Health System, others market. (more) 11/24/09 connectivity this year.
Johns Hopkins School of Intel is piloting its Intel Health Guide The devices will run on Clearwire's new
Nursing Intel, Clearwire at JH School of Nursing. (more) 11/30/09 WiMAX network in Baltimore.
GE bought LIG for an undisclosed
amount. LIG's o ering QuietCare uses
infrared sensors to remotely monitor
Living Independently patients in senior care facilities. GE owned a minority stake in LIG prior to
GE Group (more) 12/02/09 the acquisition.
Novartis is working with IBM and
Vodafone to bring SMS For Life The service aims to improve availability of
Novartis IBM, Vodafone campaign to Tanzania. (more) 12/14/09 anti-malarial drugs in remote areas.

Page 31

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

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

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
The Year in Conclusion
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.


2009 State Of The Industry

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