[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
MOBILE MEDICAL APP ENTREPRENEURS: CHANGING THE FACE OF HEALTH CARE
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH AND TECHNOLOGY
OF THE
COMMITTEE ON SMALL BUSINESS
UNITED STATES
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
HEARING HELD
JUNE 27, 2013
__________
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Small Business Committee Document Number 113-027
Available via the GPO Website: www.fdsys.gov
----------
U.S. GOVERNMENT PRINTING OFFICE
81-702 PDF WASHINGTON : 2013
HOUSE COMMITTEE ON SMALL BUSINESS
SAM GRAVES, Missouri, Chairman
STEVE CHABOT, Ohio
STEVE KING, Iowa
MIKE COFFMAN, Colorado
BLAINE LUETKEMER, Missouri
MICK MULVANEY, South Carolina
SCOTT TIPTON, Colorado
JAIME HERRERA BEUTLER, Washington
RICHARD HANNA, New York
TIM HUELSKAMP, Kansas
DAVID SCHWEIKERT, Arizona
KERRY BENTIVOLIO, Michigan
CHRIS COLLINS, New York
TOM RICE, South Carolina
NYDIA VELAZQUEZ, New York, Ranking Member
KURT SCHRADER, Oregon
YVETTE CLARKE, New York
JUDY CHU, California
JANICE HAHN, California
DONALD PAYNE, JR., New Jersey
GRACE MENG, New York
BRAD SCHNEIDER, Illinois
RON BARBER, Arizona
ANN McLANE KUSTER, New Hampshire
PATRICK MURPHY, Florida
Lori Salley, Staff Director
Paul Sass, Deputy Staff Director
Barry Pineles, Chief Counsel
Michael Day, Minority Staff Director
C O N T E N T S
OPENING STATEMENTS
Page
Hon. Chris Collins............................................... 1
Hon. Janice Hahn................................................. 2
WITNESSES
Alan Portela, Chief Executive Officer, AirStrip, San Antonio, TX. 3
Keith Brophy, Chief Executive Officer, Ideomed, Grand Rapids, MI. 5
Christopher R. Burrow, M.D., EVP Medical Affairs, Humetrix, Del
Mar, CA, testifying on behalf of the Application Developers
Alliance....................................................... 7
Sabrina Casucci, Ph.D. Candidate, Industrial and Systems
Engineering, University at Buffalo, Amherst, NY................ 9
APPENDIX
Prepared Statements:
Alan Portela, Chief Executive Officer, AirStrip, San Antonio,
TX......................................................... 25
Keith Brophy, Chief Executive Officer, Ideomed, Grand Rapids,
MI......................................................... 33
Christopher R. Burrow, M.D., EVP Medical Affairs, Humetrix,
Del Mar, CA, testifying on behalf of the Application
Developers Alliance........................................ 42
Sabrina Casucci, Ph.D. Candidate, Industrial and Systems
Engineering, University at Buffalo, Amherst, NY............ 48
Questions for the Record:
None.
Answers for the Record:
None.
Additional Material for the Record:
ACT - The Association for Competitive Technology............. 51
MOBILE MEDICAL APP ENTREPRENEURS: CHANGING THE FACE OF HEALTH CARE
----------
THURSDAY, JUNE 27, 2013
House of Representatives,
Committee on Small Business,
Subcommittee on Health and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:00 a.m., in
Room 2360, Rayburn House Office Building. Hon. Chris Collins
[chairman of the subcommittee] presiding.
Present: Representatives Collins, Coffman, Luetkemeyer, and
Hahn.
Chairman COLLINS. Good morning. I call the hearing to
order.
I want to welcome all of our witnesses and thank you all
for being here. I think this is going to be a fun hearing and
showcase entrepreneurship at its best.
Today, we are meeting to learn more about how American
small businesses and how they are changing health care through
innovations in mobile medical applications, or ``apps.''
According to a Pew Center report, a majority of adults in
the United States now own a smartphone. Our overall economy is
still weak, but the apps economy seems to be thriving. Some
studies have found that mobile devices and their apps are
responsible for creating over 500,000 jobs, and global revenue
for mobile apps exceeded $20 billion last year.
Apps that can help individuals monitor their health are
becoming more prevalent and popular. Worldwide, an estimated
500 million smartphones will be using a medical app by 2015,
and 78 percent of top app developers are small businesses.
In fact, entrepreneurs have pioneered apps for purposes as
varied as tracking fitness routines to reading a patient's
digital images. These are groundbreaking medical apps to help
empower consumers to make better health care decisions; allow
patients to access critical health data in real time; and guide
physicians to diagnose or monitor patient conditions. Apps may
also help reduce hospital readmissions and cut the cost of
managing chronic diseases.
To help get these products to the public, small businesses
have to navigate a complex web of challenges, product
financing, marketing, taxes, and regulations. We are eager to
learn more about these innovations as well as the challenges
that all of you face each day in bringing your apps to market.
Today's hearing format is a little bit different. Each
witness will be allocated the customary five minutes. But
during that time, when they do testify, they are going to
actually be demonstrating their apps for us. As they explain
this app, we have got the two screens on either side which will
help visually. We appreciate the participation of all of our
witnesses, and we do look forward to your testimony.
I now yield to Ranking Member Janice Hahn for her opening
remarks.
Ms. HAHN. Thank you, Mr. Chairman.
You are right. Mobile medical apps are a real exciting area
of innovation that has tremendous promise for American small
businesses and health care providers and patients across the
country. These applications on smartphones, tablets, web
platforms stand to dramatically improve the practice of
medicine in this country, reducing inefficiencies, confusion,
and disorganization that costs money and lives.
For doctors, these applications can help put more patient
data in their hands, so they can make more informed decisions
more efficiently wherever they are. And for patients, these
applications can cut through the fog of overlapping medical
instructions and prescription medication schedules, providing
reminders and helping people to stay on track.
This is not just a matter of convenience, and it is not
just some cool-looking new toy. Medical errors kill as many as
98,000 people a year, including over 7,000 from medication
errors. That is more than die every year in car accidents,
breast cancer, or AIDS. Bringing all the patient's medical
information together and putting it literally into the hands of
that patient and their doctors could help avoid these deadly
errors.
I am particularly excited about what these applications
could do for disadvantaged and the elderly population, the most
vulnerable with chronic conditions who have a hard time sorting
through all their medications without help. If anyone has ever
taken care of someone with a chronic disease, or even
recovering from a serious illness, you know how confusing and
difficult that can be and how handy and easy-to-use application
that provides reminders and tracks treatment could be.
I want to be sure that these exciting advances in mobile
medicine do not leave behind those people that may not be able
to afford a smartphone. And on top of all those great benefits
to these apps, delivering less costly, more efficient care that
makes our nation healthier, this is a field where small
business can really lead the way. I think that is a really
exciting and really American prospect--U.S. small businesses
remaking our world with their innovation and ingenuity.
It is estimated that mobile technology industry will grow
to be valued at roughly $25 billion and account for an
estimated 500,000 jobs. The development of mobile medical apps
has steadily increased with roughly 27,000 unique apps
currently on the market, and about 500 new ones being launched
every month. So when you say ``is there an app for that,''
there will be.
Small developers are critical to the success of the mobile
medical industry. Last year, the mobile health care sector saw
venture capital investments reach more than $900 million. And
in 2013, it is expected to exceed $1 billion. However, small
MMA developers' ability to continue receiving such investment
is highly dependent on the regulatory front. That is why it is
important for us to understand how they bring their apps to the
market and ensure that the process does not hinder their
growth, which is why I am glad you are holding this hearing
today and we want to be a part of the solution to this. Thank
you, and I yield back.
Chairman COLLINS. If Subcommittee members have an opening
statement prepared, I will ask that they submit those for the
record.
And now I would like to take a moment and explain the
timing lights to our witnesses. You each have five minutes to
deliver your testimony. The light will start out as green. When
you have one minute remaining, the light will turn yellow. And
finally, it will turn red at the end of your five minutes. I
would ask that you adhere to those time limits if at all
possible.
Our first witness is Alan Portela. Mr. Portela is chief
executive officer for AirStrip Technologies, which is based in
San Antonio, Texas. He has more than 25 years of experience in
bringing groundbreaking technology solutions to market.
AirStrip's app allows physicians to securely access real-time
clinical patient data at any time, anywhere, expediting
decision-making. AirStrip was the first app approved by the FDA
for the app store.
Welcome. You have five minutes to present your testimony.
We look forward to your demonstration.
STATEMENTS OF ALAN PORTELA, CHIEF EXECUTIVE OFFICER, AIRSTRIP
TECHNOLOGIES; KEITH BROPHY, CHIEF EXECUTIVE OFFICER, IDEOMED;
CHRISTOPHER BURROW, EVP MEDICAL AFFAIRS, HUMETRIX, ON BEHALF OF
THE APP DEVELOPERS ALLIANCE; SABRINA CASUCCI, PH.D. CANDIDATE,
INDUSTRIAL AND SYSTEMS ENGINEERING, UNIVERSITY AT BUFFALO.
STATEMENT OF ALAN PORTELA
Mr. PORTELA. Thank you, Mr. Chairman. It is an honor to be
part of this Committee at such an exciting time in health care.
This is probably the biggest transformation ever.
If you look at the model today, it is changing from
hospital-centric to patient-centric. We are looking really at
an approach on chronic disease management. Unfortunately, 160
million Americans suffer at least one chronic disease. And what
we have to do is to be able to figure out a way to manage those
patients with the challenges at hand.
The challenge today is that we have a shortage of
caregivers, physicians, specialists, and we have the patient
population that is increasing by the millions under the
Affordable Care Act. So now physicians are becoming more and
more mobile professionals. The data has to be delivered to them
via mobile devices--data that is clinically relevant, so they
can make informed decisions, rather than them going to desktop
computers to be able to get that data. So definitely, the model
is changing.
Now, we have to make sure that mobility becomes a key
element to support the new model. AirStrip core products are a
medical device in mobility solutions, and they are patent-
protected, FDA cleared, and recently, we received the DoD
DIACAP certification for security. So these milestones were
never viewed as barriers to entry for us; they are considered
what make us unique. And also, it allows us to impact a number
of lives. Today, one out of every five babies born in the U.S.
are covered or are monitored by doctors that are looking at
these babies before they are born using AirStrip solutions, and
we have documented cases that moms that deliver from high-risk
pregnancies that deliver babies, those babies would have not
been alive today if it was not because of diagnostic-quality
remote in monitoring.
We also caught a number of patients with heart disease, and
I am going to use that for our demonstration as a use case. It
takes about 90 minutes for a patient with a heart attack with a
full blockage to go from the emergency department into the cath
lab so they can clear that artery with the right procedure. The
reason it takes 90 minutes is because usually a cardiologist,
the specialists are on-call and they are not in the emergency
department at all times. So they are the ones that need to make
that diagnosis, to approve the procedure.
What we do with our product is that now physicians, the
cardiologist, can actually access that data immediately when
the patient is in the ambulance; not when they come to the
emergency department. So now they can make a decision before
the patient comes in, and they can have the care coordination
team ready to take care of that patient. So we are actually
reducing the time to intervention to more than half, to 30
minutes in some cases. There is actually a firefighter in New
York that was able to go back to work after a full blockage
after three weeks and he was on national TV.
So the reality is that we are producing better heart and
muscle as a result of time to intervention, but also better
quality of life.
Also, the physicians are able to monitor patients as they
go home, also in the intensive care units. You can look at a
patient and look at all their charted data, documented data by
the nurses, the rates, the pressures, the respiration rates,
laboratory results, medications administered, but also you can
look at the alerts and you can also look at the live patient
monitor and data. This is something that can be done remotely
and it is actually diagnostic quality. We are actually taking
this to home monitoring for cardiac monitoring for cardiac
patients, patients in underserved communities, rural health
care. Now you are going to be able to monitor that remotely. We
are also taking this to chronic diseases such as diabetes,
COPD, and others.
So today, we are not representing the large companies, but
we are representing the hundreds of thousands of patients that
are alive because of those doctors and nurses that were able to
take care of those patients using our products.
The partnership with the Federal government for us really
is what drove our innovation process and the FDA made us
relevant. The DoD made our patient data secure. And together we
improve the quality of care. What we really want to urge as
part of this Committee is for the FDA to provide guidance on
the regulation on diagnostic quality medical device mobility.
So now also there is more security that is attached to this
because lack of guidance is encouraging medical device
manufacturers to offer inferior solutions and give those to the
customers without the proper clearance, which is hurting us as
a small business, but it is also hurting you and I as patients.
So the other consequence of being the first one and taking the
lead in the industry is that we are part of the only companies
that are paying the medical device tax that is introduced as
part of the Affordable Care Act when those companies are not
paying for that tax on the mobile device application.
So thank you for the opportunity.
Chairman COLLINS. Thank you. And I am sure we will have
some questions at the end of this.
Our next witness is Keith Brophy, who is chief executive
officer for Ideomed in Grand Rapids, Michigan. Mr. Brophy was
Western Michigan's Entrepreneur of the Year in 2004, and
received his bachelor's degree in computer science from the
University of Michigan. Ideomed's app, Abriiz, is designed to
improve health outcomes and lower costs by motivating patients
with chronic conditions to adhere to medication schedules.
Welcome. You have five minutes to present your testimony
and demonstrate your app.
STATEMENT OF KEITH BROPHY
Mr. BROPHY. Chairman Collins, Ranking Member Hahn, and
members of the Subcommittee, I am Keith Brophy, CEO of Ideomed,
and I appreciate the opportunity to address you today.
Ideomed is a Michigan-based company launched by Spectrum
Health with a national focus on the staggering costs of chronic
disease.
I am also here today as a member of Association for
Competitive Technology (ACT), a trade association that assists
mobile development companies in understanding and aligning with
regulations to build effective solutions. Chronic conditions,
such as asthma, heart failure, and diabetes are the untamed
frontier of health care with over a trillion dollar a year
impact to our U.S. economy. Much of this cost could be
prevented if individuals effectively manage their health on a
daily basis. This is where Abriiz and Ideomed step in. We
engage patients in assisted self-management through mobile
technology and human behavior science. We call our platform
Abriiz because our goal is to make the managing of one's health
a breeze. Abriiz represents a new breed of health application.
It does not dispense medical advice; rather, it extends the
reach of the clinician and inspires the patient to take control
of their own health. This is a winning combination.
We sell this platform directly to insurers who bear the
cost of chronic disease, such as managed Medicaid providers.
They in turn deploy Abriiz to the subsets of their populations
with the most severe chronic conditions.
As we will now demonstrate on the screen, Abriiz engages.
On our mobile device you can see the version of Abriiz which
Alex, a hypothetical patient with severe asthma would use.
Abriiz is a friend on Alex's shoulder that provides medication
reminders. An alert pops up at appropriate times and leads Alex
to quickly record his dose. For example, here he records his
dose of Advair. If he misses a dose, his mother and insurance
case manager receive alerts. If he records it, they immediately
see the results, whether they are across town or across the
country.
Alex can also record symptoms and custom triggers that fit
his life; for example, his neighbor's long-haired cat, Mr.
McFluffy, which can induce asthma attacks. This personalized
tracking allows Alex to see how asthma maps to his world. As
Alex successfully completes each day's medication, he is
awarded with digital creatures. These creatures, called
Abriizlings, are badge-based incentives the child earns over
time. Alex can also earn tailored family incentives, such as a
visit to the park. These features are based on motivational
psychology and gamification science. Their use deepens the
positive engagement Alex has with his daily management.
Alex is not alone on this journey. On the Abriiz website,
his care team can monitor Alex's daily interactions, as well as
establish medication schedules, set incentives, and view
trends. From Alex's perspective, Abriiz provides control and
confidence regarding his asthma. To his care team, it provides
conducted peace of mind.
Early on in the development of the platform that you have
just seen there were skeptics who questioned the potential of
mobile engagement. We heard misgivings about the ability to
engage children on a sustained basis, and that the need for
wireless connectivity would be too restricting. We have now
carried out many successful deployments that suggest those
concerns were unfounded.
Here you can see that in each of these small population
trials, emergency room visits noticeably declined. We have also
expanded our aim. Abriiz Heart has been in use by congestive
heart failure patients, average age 77, for over six months
with a sustained daily engagement rate of over 80 percent.
Engagement rates across our Medicaid asthma initiatives have
similar affirming numbers.
We continue to expand our portfolio to other conditions,
including diabetes, cancer journeys, and more. We started just
three years ago with a visionary seed funder and spectrum
health and a determination to make a difference. We have
blossomed from start-up with a couple team members and no
office to a booming business with 32 expert team members with
diverse skill sets and a national product line. Our original
product was a sleeve device that slid onto an asthma inhaler to
provide medication reminders.
It became clear that the mobile technology landscape was
rapidly offering alternative approaches. We found the cost to
achieve FDA device approval and bring the sleeve to market
would be prohibitive, so we shifted strategy, leveraged the
insights we had gained, and mobile-based Abriiz was born.
We are vigilant about building solutions that are of the
highest caliber for our users and that safeguard their data.
Our success has been shaped by our ability to turn assumptions
upside down and ultimately to empower individuals to steward
their health with a connectedness of a broader team.
We look to a future of touching lives and peer ahead to
anticipate the still emerging FDA mobile health guidelines.
Ideomed encourages and welcomes clear, timely, and right-sized
governance. These are historic times of change in American
health care. We are proud to be an engine of responsible
transformation to a new era of mobile patient engagement. Thank
you.
Chairman COLLINS. Thank you, Mr. Brophy.
At this time I would like to yield to Ranking Member Hahn
for her introduction of our next witness.
Ms. HAHN. Thank you, Mr. Chairman.
It is my pleasure to introduce Dr. Chris Burrow. Dr. Burrow
is executive vice president for Medical Affairs at Humetrix. Is
that right? Did I pronounce that right? Humetrix, a small,
woman-owned business in Delmar, California. Before joining
Humetrix, Dr. Burrow was an executive and founder of two
California start-up biotechnological companies. He is here
today on behalf of the App Developers Alliance, an industry
association dedicated to meeting the needs of developers as
creators, innovators, and entrepreneurs.
Welcome, Dr. Burrow.
STATEMENT OF CHRISTOPHER BURROW
Mr. BURROW. Thank you, Chairman Collins, Ranking Member
Hahn, and distinguished Subcommittee members. Thank you for the
opportunity to appear before you today. It is an honor and a
pleasure. I appreciate it.
My name is Chris Burrow, as you have just heard, and I am
EVP Medical Affairs at Humetrix. And as you also heard, a
small, woman-owned business in Delmar, California. We are a
member of the App Developers Alliance, and we appear today on
their behalf.
Humetrix was founded in 1998. It has been a pioneer in the
development of mobile technology. Over the last 15 years we
developed numerous mobile applications that enable consumers to
engage the world around them in new and innovative ways.
Despite significant progress in electronic health record
adoption in the last few years, essential health information is
still not readily accessible by patients in today's provider-
centric health care system. By enabling patients to access
their own health information at the point of care with an easy-
to-use mobile application, Humetrix's IBlueButton Solution, our
app, is free of many of the challenges encountered by the
current system-to-system health information exchange
initiatives in the nation. Our technology, IBlueButton, is
based on the federal Blue Button initiative. I have the icon
right here on my lapel, Blue Button. The idea is very simple.
Give patients access to their own health information using an
easy-to-identify symbol that could be adopted and used by any
organization holding valuable patient data, a Blue Button.
Humetrix recognized the transformative potential of Blue
Button data early on and built on these federal efforts by
creating the IBlueButton app, both for IOS devices and Android
devices, to provide patients and care givers with easy,
reliable, and secure access to their health record as
maintained by both public and private payers.
For Medicare, our application transforms the beneficiary
level claims data currently produced by the CMS blue button
record into a user-friendly, longitudinal health record that
can be accessed on a mobile device and exchanged by patients
and providers at the point of care. This comprehensive health
record can be viewed directly on a smartphone or tablet and
contains a patient's key health information, such as problems,
medication list, as well as a detailed history of all the
patient's health care encounters, including inpatient
admissions, outpatient visits, imaging services, labs and
procedures.
I will now briefly demo our technology. So on the screen is
my iPad, and here I am playing the role of a patient first. So
I am going to launch the blue button app. And the first thing I
have to do is I have to put in my password because this is a
password protected app so that no one else--if I lose my phone,
no one else can get into this. And the data is held at high-
level encryption on the device. In order to download a Medicare
record, the only thing a Medicare patient has to do is go to
Mymedicare.gov and fill out a brief questionnaire designed by
Medicare to get a user name and password. Once they have
acquired that user name and password, they simply enter the
user name and password here into the app. They save it, and now
they are ready to download their record.
All they have to do to download their record is hit that
download button and here is the record. The record is laid out
beautifully. We have diagnoses showing all the conditions that
the patient has. For any one of those, the patient can do a
quick lookup of what that partly Latin term may mean. It is not
so easy, and if you are not completely conversant in English,
it is even harder.
You can also see all of your medications, not just the
medication from the doctor you saw today, but all the
medications that have been paid for under Part D. So that is
quite, we think, transformative.
And here they all are. For any medicine you can do an easy
lookup of drug information. That will give you basic
information that comes from the National Library of Medicine
telling you how you should take that drug, what you should
watch out for. If you have any side effects, you may not know
what they might be and here you can check them. If you see one
you can enter yes. And so basically, now you have got your
whole medical record under your fingertips wherever you want
it. When you see your physician, I do not have time to show
everything, but we have a companion app. You can push the
record over to the physician's device. We generate a novel,
optical QR code, and the physician can now scan your
smartphone, which is displaying a QR code, and the record is
now shown on the physician's device. All the physician needs is
an iPad and our technology from either the Play Store or
iTunes. And these alerts that the patient has entered will now
be shown as little exclamation points saying whether the
patient is or is not taking that medication and whether they do
or do not have that condition.
Well, my time is up. I have gone pretty fast. I am
delighted again to have been here and I want to thank everyone
for that. Our one ask is we are trying to get the word out.
Patient education is key. Provider education is key. We are
working with private and public stakeholders to do just that.
Thank you very much.
Chairman COLLINS. Thank you, Dr. Burrow.
Our next witness is Sabrina Casucci. Ms. Casucci is a
doctoral candidate in Industrial and Systems Engineering at the
University at Buffalo in Buffalo, New York. She holds a
bachelor's degree in material science and engineering from
Purdue, and a master's degree in business administration from
the University at Buffalo. Ms. Casucci and her colleagues, who
we are happy to say are joining her today--welcome--received
second prize in General Electric's Hospital Question
Competition for their app, which introduces patient and
caregiver choice into the discharge process and supports timely
communication between the hospital and community care teams.
Hospital readmissions are reduced, saving money.
Welcome. You have five minutes to present your testimony
and demonstrate your app.
STATEMENT OF SABRINA CASUCCI
Ms. CASUCCI. Great. Chairman Collins and distinguished
members of the Subcommittee, thank you again for the invitation
to participate in today's hearing. I am honored to represent a
talented team of fellow graduate students from the University
at Buffalo Department of Industrial and Systems Engineering.
I want to briefly discuss how our group of young
entrepreneurs are translating our individual health care and
technology-related research into a mobile solution that will
make hospital discharge planning a more effective and efficient
process.
Discharge planning is a critical step in acute patient
care. Yet, the inherent complexities of existing processes
often result in undesirable outcomes for both the patient and
the health care system. Annually, nearly one in five Medicare
patients is readmitted to a hospital within 30 days of their
initial discharge, with a cost of more than $17 billion. But
despite recent efforts to make improvements in these areas,
readmission rates have remained relatively constant. The recent
GE Health Quest competition provided the catalyst for our group
to develop a better solution for discharge planning, and we
believe Discharge Roadmap will fundamentally redefine the
process. Solutions like ours can fundamentally have a
significant impact on health care in the U.S. Mobile solutions
can connect fragmented care processes and improve continuity of
care, both contributors to improved patient outcomes and
reduced costs of care.
However, as a startup group in the early stages of
development, there is a long and difficult road ahead. In
addition to difficulties in obtaining funding and support for
our product, we must confront complex technical issues such as
interoperability. Improving interoperability standards will
ensure that health care providers can choose a solution that
best fits the needs of their patients and not just the needs of
their existing health information technology systems. Through
our app, we seek to make a meaningful contribution to reducing
readmission rates by facilitating communication among patients,
their families or informal caregivers, and hospital-based
clinicians, and by improving continuity of care with community-
based care providers.
I am going to take the next few minutes to give a brief
overview of our app and a few of the unique features that it
provides.
This is best demonstrated with an example of John, an 80-
year-old patient hospitalized for congestive heart failure. And
despite her busy schedule, John's daughter, Jane, is the only
informal care giver available to help John in his recovery.
Discharge Roadmap is designed to facilitate the discharge
planning process, allowing it to begin much earlier in John's
hospital stay. Using our app, John, Jane, and John's doctors
can be assured that all care needs and constraints are
adequately considered in the process.
Today, bringing together these stakeholders to develop a
discharge plan is a difficult undertaking. Using a systematic
approach, we can connect this team and using the tools provided
by Discharge Roadmap, improve their communication and
coordination.
These customized tools can be categorized into three main
functionalities--education, assessments, and referrals. John
would first experience the educational component of our app,
and in this section he can review several short modules
explaining his diagnosis and care management, the same material
that is available to Jane so that she can also learn the best
ways to assist her father in improving his care. As John
completes progress through this area, the results of his short
teach-back quizzes are provided to both him and his doctor.
After learning about his diagnosis and how to manage his care,
John and Jane can both independently assess what his abilities
are to manage his care post-hospitalization, as well as their
abilities to meet those needs.
John's doctor will also complete their own assignments, and
then is presented a prioritized summary of the results of all
three of these assessments, allowing her to focus discharge
planning discussions on areas where there is some discrepancy
or inconsistency in answers. Once John's doctor then determines
his post-discharge care needs, such as home care, John can
learn about these services. In addition, he is provided an
evidence-based prediction of what his outcomes would be if he
were to follow through with those recommendations. The key
piece then after that is figuring out who is going to provide
this service. John and Jane can also review the local service
providers and indicate their preferences for who they would
prefer the referrals to go. And then, as Jane certainly is the
one who will be taking her father to these appointments, it is
important to know what her schedule and constraints are so she
can also then communicate her availability through our app to
the appointment schedulers.
And finally, our referral features provides continuity of
care with community-based care providers by allowing John's
doctor to quickly assemble and transmit detailed referrals to
those community-based care providers.
So combined, we believe our education assessment and
referral components are really redesigning the discharge
planning process and we are honored to have shared them with
you today. Thank you.
Chairman COLLINS. Thank you one and all. I think as we move
forward with technology, I think we are going to be relying
more and more on entrepreneurs to come up with solutions for a
variety of reasons. In some cases it is to make money; in other
cases it is to pursue your continued education. But in each of
your cases, what you have given us is a great look at the
marriage of entrepreneurs and technology and where we might go.
And I would say really where we are going. All of us know
health care costs are a number one concern. They are a number
one concern to individuals--can they afford it--whether it is
the cost of their drugs or insurance. For corporations, they
are facing those issues now as we move forward into a new
world. And anything we can do to reduce the overall cost. And I
think the solution is patients starting to take control of
their own lives. In the past, the old model was you had
insurance, you went to the doctor, you did not know exactly
what it cost because someone else paid it, and you went home.
Well, today, it is a very different model, and I think what you
are showing is the next stage of patients taking control. But
as we have got an aging population, certainly, the baby
boomers, of which I am one, retiring 10,000 of us a day, and
the story you are sharing of an 80-year-old man with his
daughter helping out--Ms. Hahn wanted to know where the son
was.
Ms. HAHN. Always the daughter.
Chairman COLLINS. Always the daughter.
That is the world we live in. Our parents are living longer
because of advances, but in many cases they are on some kind of
chronic medication and/or we are always worried about
admissions to hospitals. So you have made great strides.
So my first question, really, because we do not have all
the regulations out and I know with IBlueButton what you have
done will maybe--in fact, why do we not start with Dr. Burrow
on the HIPAA issue, the privacy issue? You mentioned if you
lose your cell phone someone is not going to be able to get in
and get that information. And I know we are all concerned about
privacy and who has access to our medical information. So maybe
you could explain what you are doing. And then I am curious to
hear whether that is an issue for the other three witnesses.
Mr. BURROW. Thank you, Chairman Collins, for that question.
It is a very important question.
Our view, and the way we have designed these apps, is that
you, the patient, should be able to access your own records.
You acquire the credentials to do so from the data holder. The
example I gave is Medicare. So you go to the Medicare website
and you comply with the requirements of that data holder. So
once you have done that, as we frequently see in banking and
other aspects of our lives, you acquire a user name and
password. That is securely scored in the IBlueButton app. It is
encrypted and the download takes place in a secure fashion. And
the record, once on your phone, is, in fact, encrypted and
stored there so that if you lose your phone, the only data that
could be acquired maliciously would be a file of encrypted ones
and zeros, which would be--I hesitate to say impossible, but
virtually impossible to break. So your data is secure, and
losing a phone would not be a problem. No one would have the
password to get into your app and no one would be able to see
your data.
Chairman COLLINS. Thank you.
Mr. Portela.
Mr. PORTELA. Well, as I mentioned before, we just received
a certification for DoD and it is called DIACAP certification
for security. It is our position as we are going through that
process with the Department of Defense we clearly recognize the
risks for cyber attacks out there that are way beyond what the
private citizen will see. Basically, the way the DoD handles
the security through the DIACAP certification is that they have
a number of engineers that are looking for hackers on a regular
basis, and every time they find hackers trying to break in,
they are automatically publishing those vulnerabilities to all
the vendors that are DIACAP certified.
So what we need to do as vendors is immediately identify
how we are going to mitigate those vulnerabilities, and in some
cases they are category ones, which they consider these are
very risky, but every month they are identifying new
vulnerabilities that could break the patient data. So what
happens is that if at some point we start getting closer and
closer to the medical devices and eventually managing those
devices remotely, if we are vulnerable to hackers we are going
to have a lot of problems. HIPAA, today, and the FCC with the
open SSL standard, they primarily direct the security to the
application level but they do not do that on the operating
system level so much. The DoD requirement, it keeps audit
trails on everything that happens also in the operating system,
preventing hackers from coming in. So what I recommend is that
we take a look at what the DoD is doing and bring in some of
that certification process into the private sector.
Chairman COLLINS. Thank you.
Now, Mr. Brophy, your example was a young man whose family
is watching him. I am assuming, too, that would apply not just
to kids, if I am correct, but also, again, how does your app
manage HIPPA and privacy and is that a worry for you?
Mr. BROPHY. The privacy and protection of data is something
we take very seriously in designing the app. And we have an
approach that is similar to those shared with encryption at the
technology level. And also, above and beyond that, the people
process that is built into the application is an important
element. For example, our data is self-reported data reported
by the patient, but the model supports the care team that can
remotely monitor their data. That access is not provided unless
the patient or their guardian specifically consents to sharing
their data in that fashion. So we build the people approval and
the technology protection in two layers.
Chairman COLLINS. Thank you. Ms. Casucci, how does your app
handle the privacy issues?
Ms. CASUCCI. Sure.
Well, we are still in the development process of our app,
so we have no official solution to that yet, but that is
certainly one of the concerns from that startup perspective. So
we know that there are various standards that we do need to
adhere to. And figuring out how to navigate that standard
system and trying to determine the proper solution for our app
is that first big hurdle. So it is certainly one of those
barriers that we need to overcome and understand better.
Chairman COLLINS. We will come back for some other
questions, but at this point I will yield to Ranking Member
Hahn for her questions.
Ms. HAHN. Thank you, Mr. Chairman.
Ms. Casucci, you touched on interoperability. And when I am
listening to everybody's presentation, which were all extremely
interesting and really very exciting and certainly where we
need to be in terms of quality health care, obviously, you
know, the doctor who would be treating the patient for a kidney
problem would have to be able to talk to the cardiologist who
is treating the heart problem. I would ask that to all the
witnesses, is this a problem, interoperability, and what do we
need to do in Congress to encourage the interoperability of
these applications and health care data systems overall?
Ms. CASUCCI. So really what we view on this is that
integration of our system is really key. So we as a third-party
vendor need to talk with everybody. There really are several
different types of standards that people are discussing
currently but no unified or agreed upon standard as to how
these different technologies can communicate with each other.
But we do not see data as that competitive advantage; we see
the communication piece at enabling that. So if we can do that,
then we can eliminate all these needs for redundant testing and
really reduce the cost of care by enabling test results from
one facility or one system to be communicated across to
another.
So really, what we are looking for is just some guidance as
to what is the best approach to do all this. Do we need to
create customized solutions for each different software vendor
that is out there? Or can there be more of a unified agreement
that we can all work towards and then communicate via that?
Ms. HAHN. Thank you.
Mr. Portela.
Mr. PORTELA. Thank you. And I do have about 20 years
experience in this area. Yes, interoperability is a huge
problem.
What happens is we are not lacking the standards; the
standards need to be enforced. And what happens also then there
is a tendency to protect the data to preserve some of the
advantages that they have. And I am talking primarily about the
large vendors. So you have to look at front-end integration and
backend integration. The front-end is more around the episode
of care, and the backend is really maintaining a longitudinal
record. The backend is going to take 10 years until really the
vendors start supporting the standards that the government has
to enforce that are not enforced today. But at least what we
are trying to do on the mobile side with mobile technology is
dealing with the episode of care. All of us really trying to
capture the data from all these systems to be able to display
that episode of care. So physicians can look at electronic
medical record data, medical device data, images,
videoconferencing for telehealth, and others.
Unfortunately, the only standard that exists that most of
the vendors support is something that is called a continuity of
care document (CCD) that is a very small subset of the data
that you can get from a patient visit. The real data, you have
to get it from interfacing to each of those vendors, and there
are different ways of doing that. But definitely there is one
standard that is called HL7 standard that at least all of us
are trying to comply with that and it gives you the ability to
take data, receive the data, but right back into those systems.
But vendors need to be forced to collaborate. We are in a new
world.
Ms. HAHN. Any other witnesses?
Mr. BROPHY. I would agree with Mr. Portela. The standards,
such as HL7, are out there, and the mobile application vendors
build solutions that often can be integrated if the other side
of the equation has the bridges for that integration.
In the case of Ideomed with Abriiz, we build it to be what
I would describe as a flexible building block. It can plug into
other systems, and it can plug into various scenarios. As we
look at the healthcare landscape in the case, for example, of a
congestive heart failure patient, when they are discharged from
the hospital their care team could be a varied cast of
characters from an insurance company case manager, to a
cardiologist, to a heart education nurse, to a visiting home
health nurse, to family members. So there are not only multiple
players but multiple data systems that could potentially share
the data. Companies, such as Ideomed, build flexible pieces.
Then it is a matter of finding out where in the ecosystem they
can integrate.
Mr. BURROW. Thank you for that question. So our national
strategy is built on three different approaches. One, system-
to-system exchange between doctors or EMR systems. And you have
heard a little bit about that so I will not comment. The
patient-consumer mediated exchange model that we embody is this
other idea, the new idea that if everyone has access to a
summary medical record that they can carry, if you will, on
their mobile device, that will help solve the interoperability
problem out there. Humetrix has been part of the Blue Button
initiative. We have come together both on the private and
government side to define new Blue Button plus standards, which
we believe will be important going forward to mediate this
patient model where you have on your phone your record. After
all, for your financial information you have an ATM card and
you get your data easily. So our vision is that every citizen
should have the ability to get their data and have it with
them.
Ms. HAHN. Thank you. Again, I just think that is something
we ought to look at as we move forward. The technology exists,
but interoperability is so key. I look at that in so many
areas. Even law enforcement still is struggling with
interoperability in the event of a major disaster. We still
have a lot of different agencies out there that cannot talk to
each other. So I think it is something we need to look at.
I have got more but I will save them for the next round.
Chairman COLLINS. Very good.
Thank you. At this point in time we would like to recognize
the gentleman from Missouri, Mr. Luetkemeyer, for five minutes.
Mr. LUETKEMEYER. Thank you, Mr. Chairman. I guess this
means I have got to put my rotary phone away.
Thank all of you for being here today. I know last week I
was very disappointed and actually was very frustrated by the
lack of information in the testimony of the witnesses. Today,
it is very encouraging to see witnesses that are absolutely on
the cutting edge and have the answers. And I admire what you
are doing and I quite frankly hope you keep it up because
obviously it is going to make this a better world for all of us
what you are doing. So thank you.
Very quickly, what regulations are in place that you have
to deal with every day with regards to the barriers that are
put in front of you that you have to overcome that we could
have an impact on to help make your job of developing these
things easier or running your businesses better? What do you
see as some problems?
Just go down the line. Mr. Portela.
Mr. PORTELA. So I can start. And again, I think I am just
one of those rare vendors that are really here to propose
regulation. And when it comes to diagnostic quality, when it
comes to saving lives, when it comes to moving into a model
outside of the four walls of the hospital, we want more
regulation from the FDA on diagnostic quality and security. So
the reality is that we deal on a day-to-day basis with the FDA
as we submit new products and enhancements to the existing
products, but we feel that that process is improving
significantly. What we want to make sure is that right now we
are proactively complying with requirements that are not out
there yet. We would like the FDA to really recognize what we
are trying to do as a leader in the industry and the impact
that we are bringing to patient safety and to be able to go
across the board and really make the regulations so everybody
has to comply with the same regulation.
Mr. LUETKEMEYER. Very good. You guys are on the cutting
edge here, so a lot of times the rules are not there to be able
to reign in or to allow what you are doing to be done in a most
effective and cost-efficient way.
Mr. Brophy.
Mr. BROPHY. We understand and align with regulations such
as HIPAA and protection of privacy. Our key regulation that
will impact us is the FDA mobile health guidelines. And we look
forward to those governances and the clarity that it will
provide. The last couple of years as we have designed the
system, we have anticipated and speculated what the eventual
mobile health guidelines may be, so we have tried to be
proactive and build a solution that will align well with the
FDA guidelines. But that is with anticipation and expectation
of what they might be. So we welcome those guidelines when they
roll out.
Mr. LUETKEMEYER. Dr. Burrow, your group?
Mr. BURROW. Right. So I think the regulations that might
affect us the most are HIPAA, and we have designed our solution
to be fully compliant, both with encryption on the device and
in the technology I did not get to show, the encryption with a
one-time key when you push the record to your doctor. Since
Humetrix does not store any data--in fact, Humetrix has no way
of touching your data. You have your phone, you download your
data, you own the data. Humetrix is not a part of that. We do
not store your data.
So that is the one that we are thinking most about. As a
member of the App Developers Alliance, of course, we support
the approach that will be flexible and will ensure patient
safety, and I echo some of the comments of my colleagues here.
For us, right now, I am not a regulatory expert but I do not
have anything additional to add to my colleagues on those other
subjects.
Mr. LUETKEMEYER. Ms. Casucci.
Ms. CASUCCI. I will just agree, certainly, and support
everything that has been said so far. From the very early
stages of this I will say certainly you are navigating that
regulatory system and understanding really what your options
are and how you need to comply with some of those. So that is
really the point that we are at at this point, is how to best
implement the right levels of security to comply with those
regulations.
Mr. LUETKEMEYER. Very good.
I have just got 30 seconds left here, so quickly, I think
measuring the success of what you do is going to be very
important. The difference you are making in the lives of the
people. Is there a measurement that you have been able to
establish so far, a way that you tried to measure this both in
success of saving lives or better lives lived or the cost that
you have been able to save, monies with what you are doing, Mr.
Portela?
Mr. PORTELA. Yes. So definitely in today's economy, no
vendor can actually bring their systems to the market without a
clear ally--organizational, clinical, and financial. So
everything that we do we look at the value. We do assess models
so we have to demonstrate the value at every step of the way,
otherwise, the customers will go away.
And what we are doing, if we just take that cardiac patient
that I was explaining before, you reduce the time to
intervention, better quality of life. You reduce false
activation of cath labs when patients are coming in and they
activate the cath lab that they do not need to $7,500. That is
what you save every time that you activate the cath lab and it
is not necessary. Then we reduce the length of stay in the ICU
because better quality of your heart muscle, less time in the
ICU. And then also--that is about 0.85 days length of stay
reduction. And then also, when looking at the readmission, the
reduction of readmission for cardiac patients that are under
the Affordable Care Act, two out of the three conditions that
are going to be penalized for 30-day readmission are cardiac
conditions. And we are also seeing a decrease of 25 percent on
readmissions, which is a significant problem in the U.S. And
you can continue in each of the service lines and see we have
for each service line on obstetrics, patient monitoring. What
is the benefit that we bring to the table?
Mr. LUETKEMEYER. My time is up. I have to ask for the
indulgence of the chair if we want to continue with this.
Chairman COLLINS. No problem. We would like to hear the
rest of the witnesses.
Mr. LUETKEMEYER. Okay. Thank you.
Mr. Brophy, it is interesting to hear that you have to have
a cost-benefit analysis of each one of these apps brought to
the table in order to be able to fully develop it. Is that what
you have experienced as well, Mr. Brophy?
Mr. BROPHY. We have experienced that. And as I shared in
the testimony, we faced initially skepticism about the power of
mobile health apps to engage. So we have laid out a very
careful stepping stone journey to progressively build proof
points, and more and more proof points. We have started with
health outcome measures, and one of the most significant, you
saw the chart of the reduction in ER visits. But other health
outcome measures as well. All outcomes have been affirming and
positive. As the next step, we are collecting cost data,
working with multiple insurance companies so we can have the
hard cost data that maps to the health outcomes. And we
likewise continue to scale up in the scope and size of our
clinical trials so they will have more and more relevance. So
we look at a combination of improved health and improved cost
backed by black and white data.
Mr. LUETKEMEYER. Okay. I would like to stop right there.
Can you give me, for instance, on one of your apps, did you
have some data that showed how many lives it would save? Or the
amount of money saved by lessening the amount of time in the
hospital or in recuperative care?
Mr. BROPHY. Right. We have hard data on areas like the
reduction in ER visits for select measured populations.
Mr. LUETKEMEYER. Can you give me one?
Mr. BROPHY. Yes. We had a study of Medicaid asthma
patients, 26 individuals. They had 12 collective ER visits
prior to the six months of a study, and during the six months
of our study that was reduced to zero ER visits.
Mr. LUETKEMEYER. Really?
Mr. BROPHY. So we can project that to other staggering cost
savings. In the world of clinicians and insurers, there is a
high bar of diligence for proving out just such claims, but the
early health outcomes would suggest that the cost savings will
be very significant.
Mr. LUETKEMEYER. Mr. Burrow.
Mr. BURROW. We are early on and have not collected data
that would directly answer your question; however, I would say
that many studies have shown that having a complete
comprehensive list of medications that have been prescribed to
the patient when they present at the point of care is crucial
in preventing the adverse drug reactions that were cited by
Ranking Member Hahn; namely that as many as 7,000 of the 98,000
preventable deaths per year are from adverse drug reactions. So
we are intrigued by going beyond that obvious point to collect
data but have not yet done so.
Mr. LUETKEMEYER. I appreciate your testimony. And Ms.
Casucci, I guess you guys are still in the development stage;
right?
Ms. CASUCCI. We are.
Mr. LUETKEMEYER. Have you got some data that shows what you
can anticipate saving?
Ms. CASUCCI. More anecdotal evidence at this point.
Mr. LUETKEMEYER. Okay.
Ms. CASUCCI. So there certainly will be, we anticipate, a
reduction in readmission rates, so there is going to be some
cost savings from that, but we have been looking at more the
intangible costs at this point. So the benefit to having that
better understanding of the care process on both the patient's
behalf and their caregiver. So having this more complete
understanding and comprehension of what those care needs are is
certainly going to have a lot of intangible cost to the health
care system and a more longer term perspective.
Mr. LUETKEMEYER. Very good. I appreciate the chair's
indulgence. It was very informative. Thank you.
Chairman COLLINS. Thank you.
I have just got kind of a general question as we are going
through this, and that is your financial model. Three out of
the four of you are in business. We talk about return on
investment, and I think it is just always intriguing as
entrepreneurs come forward ultimately to say how do you make
money on what it is you are doing? I thought it was an
interesting comment Mr. Portela made that as he is developing
his app he is already subject to the medical device tax of
Obamacare because it is not based on profits; it is based on
revenue. But that is a slightly different topic.
I am just curious, because I am already hearing one of you
is focused on selling to an insurance company; some of you may
be focused on selling to consumers; there may be different ways
to get to market, and part of an entrepreneur's job is after
you have invented this great app, how do you get it out there?
How do you get customers? And so just real briefly, I would be
curious to hear the different financial models to the extent
you would like to share that.
Mr. PORTELA. Yes, of course.
Firstly, I want to mention if we look at what happened over
the last few years at AirStrip, we had significant growth in
the last three years but definitely we are starting to see a
significant impact from the beginning of the Affordable Care
Act because definitely I think the model eventually could work
because you are reducing the reimbursement and putting more
money on uninsured patients that eventually will come back into
the system and increase admissions to the system. But I think
that starting in April, sequestration created a huge, huge
problem. If you just look at in New York, North Shore Medical
Center, from 20,000 patients, cancer patients, they are
rejecting 16,000 of those patients because they cannot afford
to keep those patients on the system. So we are starting to see
throughout all health care organizations the fact that they are
starting to look at their operating expenses. They were looking
more at how to manage the Affordable Care Act as it came in but
nobody was ready for sequestration.
So what happens is we are partners to those health care
organizations. We are here because we have the passion to make
an impact to the quality of care. We started with models,
always a success model, subscription as a service, partnering
with them and going at risk. So what we are doing right now is
evaluating our prices and make sure that we clearly measure the
benefit that we bring to them so at no point they are losing
any money. So that is our approach.
Chairman COLLINS. Thank you.
Mr. Brophy.
Mr. BROPHY. We do sell to insurance companies and
specifically, we sell population licenses. So we provide
licenses that cover a broad swath of an insurer's population.
They focus Abriiz on the subset that has the most severe
conditions. We work together to roll it out to those
populations. And the savings that the insurer realizes as the
ER visits are reduced go directly to the insurance company's
bottom-line. So we are a return on investment sale proposition
for the insurers by purchasing the licenses for their
population and employing it they reduce costs significantly.
We do sell as well to health systems, accountable care
organizations, also to hospital systems that may be focusing on
reducing Medicare readmissions or aligning with meaningful use
guidelines. So we have a number of potential sales candidates
within the health ecosystem but insurance companies,
particularly the managed Medicaid insurers, realize the most
direct cost benefit from the purchase.
Chairman COLLINS. Thank you.
Dr. Burrow.
Mr. BURROW. Right. So our apps are currently available on
the iTunes store and the Play Store. And individuals can use
our apps. Thirty-seven million Medicare patients can go acquire
these apps. The app is free to download. We have a nominal
charge for when they use the app to download and process the
Medicare record, which is a few dollars for five records or a
few dollars more for 25 records. We give a credit--every time a
patient pushes that record to a doctor and shares that record
with their doctor they get credited back. So if they download
the app and use it frequently to share, the cost is really
nominal.
We believe that Medicare CMS should consider policies that
allow reimbursement for this type of technology, and we would,
of course, be happy to discuss that with CMS. We think that
having every Medicare beneficiary have access to their
medication list, their problem list, their past procedures and
all their doctors is a self-evident good. So we would be happy
to discuss that with CMS further.
Chairman COLLINS. Now, if someone was going to download
your app, what is it called?
Mr. BURROW. IBlueButton. Thank you for asking. Thank you
for asking. Getting the word out is important.
Chairman COLLINS. That is the business side of me. Glad to
do that.
Mr. BURROW. Thank you.
Chairman COLLINS. Ms. Casucci. I know, you are still in the
development and we chatted earlier. Have you thought of the
financial piece yet?
Ms. CASUCCI. We are. That is one of the big questions that
we are tackling at the moment. So our goal certainly is to have
the most people being able to use our app to obviously get the
most benefit from it. So there are several options about how to
best position our product to be able to do that, so I thank the
panel here for giving us some interesting insight into how
their models are and how they are working.
Chairman COLLINS. Thank you.
I see we are joined by Mr. Coffman from Colorado. We would
certainly welcome any questions you may have for this very
dynamic and appropriate panel in this technological age.
Mr. COFFMAN. Well, thank you all for testifying before
Congress today. I have a Veterans Committee hearing scheduled
at the very same time, so I left that early to come over here
in interest for what you are doing.
I wonder if you could just, all of you, say what is the end
state in terms of--and I think in terms of the questions that
we all have surrounding health care quality, access, and cost,
and how what you do influences those three critical areas that
are so important to the American people?
Mr. Portela.
Mr. PORTELA. Okay. So, of course, you are mentioning
quality, access, and cost. I think in our testimony we are
addressing those three areas. Just so you know, we are a big
proponent of, as I mentioned before, of the FDA regulating
medical device mobility because as we are moving, as I said
before, into a patient-centric model outside of the four walls
of the hospital, as we have fewer physicians taking care of
more patients today, it is very important that the data that
they get is really diagnostic quality and that they get that on
a real-time basis. And the real-time basis is also very
important. So that is as it relates to quality.
I think the area of cost also it is very important. I was
mentioning before that we are partnering with a number of
health care organizations like Dignity Health Care, Ardent
Health Care, HCA, that are helping us to really figure out what
is the right model moving forward. With all the different hits
they are getting, we were talking about sequestration and the
impact that brings into many of these health care
organizations. So as far as cost, we are putting the models in
place with them, and in some cases we are going on a risk-
sharing basis to be able to work with them.
As far as access, what we talked about is the challenge of
interoperability. The fact that there are a number of standards
for health care information exchange but standards that are not
enforced by the government and the vendors are not complying
with, even though there are standards as we mentioned before,
like HL7, there are certain areas of HL7 where the vendors get
flexibility to put proprietary formats in that language. And
for some reason, all the vendors decided to put 99 percent of
their data there and 1 percent following the standard. So the
Federal government really needs to take a very hard look into
this and force all of us to collaborate. We are not realizing
that as we move into an outcome-based reimbursement model, no
longer fee for service, and as we are having the issue with
shortage of caregivers and patients increasing, we are not
going to be able to sustain this model without innovation and
without vendors collaborating. We are all going to be
responsible for this system to collapse if we do not open up.
Mr. COFFMAN. Okay. Mr. Brophy.
Mr. BROPHY. Yes. Our model is built with a desire to make a
difference in the areas of quality access and cost, so I
appreciate the question.
The insurance company of today, the managed Medicaid, the
fixed price provider, essentially, manages the population,
including those with severe chronic conditions, and often does
that through case mangers. The case managers often reach out
occasionally through telephone calls to try to connect with
those patients, and we work directly with those case managers
across the nation. And they are incredible individuals. They
care. They are expert, and they can make a difference if they
can just connect with, for example, the severe asthmatic. We,
through our mobile application, give that case manager the
opportunity to be present in a sense every day of that child's
life with severe asthma, a connected way that is right there in
the child's life that rolls back to the case manager website.
They can provide incentives and motivations and insight. So we
increase the scale and the reach of the case manager. In turn,
that provides access. The solution has been deployed from urban
Detroit to rural Kentucky for populations that otherwise would
not have access to a daily stewardship of their condition. And
in terms of the cost equation, we have targeted insurance
companies because our belief is that as we lower the costs for
insurers that plays a significant role in lowering the cost of
our nation's health care and lowering the costs of everybody's
access.
Mr. COFFMAN. Mr. Chairman, can I have a unanimous consent
to have one more minute?
Chairman COLLINS. Absolutely. This is very interesting.
Mr. BURROW. Thank you for the question, Congressman
Coffman.
Given that you were just at the VA Committee, I should
mention that our app also gives every veteran the ability to
download their Blue Button record from the My Healthy Vet
website.
What use case are we trying to solve? How are we trying to
help? The veteran often gets care both at the VA and outside in
the private community. By giving the veteran the ability to
download their record from My Healthy Vet, which is output from
Vista, when they see a physician out in the community, that
physician now can see the record that our app is delivering,
either on the patient's own smartphone or our smartphone allows
the patient to transfer that record with an optical code to the
physician's iPad. So this is a key problem for the VA that
currently fax is often the mode of communication. So we believe
by offering this, this is an important way we can affect
quality of care and cost for the Veterans Administration. And
we are on the VA website as a Blue Button partner listed there.
Veterans can go there and link to our app and download our app
from iTunes or Play Store.
Mr. COFFMAN. Please.
Ms. CASUCCI. Great. So as industrial engineers, these are
certainly concepts and ideas that are very near and dear to us.
So our goal of designing this, what we set out to do is really
to try to reduce these costs of redundant or rework care, if
you will. So what we try to do from the quality perspective is
really improve the comprehension and the understanding of what
that care process is and what the steps--not only what the
steps are you have to do but why you should be doing them. And
what we hope to do from that through our assessment portion of
it all is to understand not only what that level of
comprehension is but what are the other constraints that are in
this individual or this family's situation that could prevent
them from enacting this level of care that was prescribed. So
if there are conditions where the informal caregiver is a
working adult with their own family, there is clearly
scheduling conflicts that need to be considered. So if we can
take all of this into account in the beginning, then we can get
this much better and more hopefully attainable care plan at
that initial discharge, preventing all of these adverse events
and effects coming in once those plans are not really working
out as they were intended.
Mr. COFFMAN. Thank you, Mr. Chairman.
Chairman COLLINS. Thank you.
Ms. Hahn, do you have some follow-up questions?
Ms. HAHN. I do. And if you will indulge me, I was just
thinking, especially when I was listening to Mr. Portela talk
about cardiac patient, I was thinking about my own father,
Kenneth Hahn, who was a county supervisor in the 1960s in Los
Angeles, and his heart doctor came to him one day and said,
``Mr. Hahn, how would you like to save a life a day?'' And my
father was, like, ``Great. As long as they are registered
voters.'' No, my father said, ``Yeah, how does it work?'' And
he said, ``What we have discovered with a heart attack patient
is this golden hour. Right? If we can get to them in the first
hour, we have a chance of saving their lives.''
So his idea was to train firefighters to be allowed to
inject the drugs where they were instead of waiting until they
were transported to the hospital. My dad thought it was a great
idea, and at that point it took legislation because obviously a
nonmedical person was not allowed to administer these drugs. So
it was passed by the California State Assembly and Legislature,
and our governor at the time was Ronald Reagan. And Ronald
Reagan was going to veto the legislation because at that point
the AMA was against it, the nurses were against it, because
again, you were taking something that was in their
jurisdiction; you were giving it to these firemen. And my dad
said, ``Let me talk to Governor Reagan before you veto this.''
And so he flew up to Sacramento and he said, ``Let me give you
one last opportunity to understand what this is about.'' My dad
explained it. Governor Reagan said, ``Let me ask you one
question, Mr. Hahn. Would these ambulances, would these mobile
paramedic devices, would they be allowed to cross
jurisdictional lines or would they just be assigned to certain
cities?'' And my dad said, ``No. The point is they are at a
base hospital. Whoever is closest is dispatched to the heart
attack victim.'' And Ronald Reagan said, ``Kenny, I am going to
sign this.'' And my dad said, ``Gee, what changed your mind?''
And he said his own father in Beverly Hills had a heart attack
and his mom called an ambulance at the time in the 1960s. The
ambulance came from Los Angeles and it stopped at the Beverly
Hills property line and turned around and went back without
relaying the information to anyone else and his own father died
in Beverly Hills.
And so sitting here today, this is a great political
satisfaction for someone like me who is new around here to
think, gee, 45 years later, something that my dad actually
championed--it was the Paramedic Program--and here we are 45
years later and I think--of course, that was government. It is
very exciting to hear small business people, what I think we
are on the verge of something as dramatic and life changing,
lifesaving as what my dad championed in the late 1960s, which
became our paramedic program.
And I will let you speak, but I was thinking the latest Pew
Research Center said 56 percent of U.S. adults own a
smartphone, but that still leaves a lot of people in this
country, about 45 million people who will not be able to access
your applications because they do not have a smartphone. And I
know my district that I represent in Los Angeles is a poor,
minority district, and a lot of those folks cannot afford a
smartphone. How do we embrace this, help you to succeed, try to
support you? And how do we not leave behind 45 million
Americans who, by the way, probably are the ones that have the
medical conditions probably that would exactly need this kind
of help with their health care in general which would save
money and be more efficient? How do we not leave them behind?
Mr. PORTELA. Well, so a lot of important points that you
made. And what I would like to address first is that, of
course, the vision he had. And of course, what we need to look
at is that many times we learn a lot from what happens on the
military side because we worry, of course, of what we are going
to do in rural communities, but many of the things that we are
doing in health care today and technology come from the
military side. And we have to look at the model in the theater
of operations.
Prior to coming to AirStrip, I did 10 years of technology
into the military health system. I deployed systems in every
military base throughout the world. If you look at the theater
of operations, the battlefield, that is where a model like this
will have a significant impact because you have a medic that is
not a physician but they need to be able to take action right
there. But if you can really provide the access so the doctor
can make a decision, so if they have to inject something or if
they have to perform the procedure, now they are going to have
use in telehealth. They are going to be able to have this
doctors working with those medics to be able to save those
soldiers. So I think that is an area we can start immediately.
We have the right regulation for diagnostic quality. We have
the right regulation for security, for the DoD, and then really
bring those models into the private sector supporting
underserved communities.
Now, the issue about people opposing an idea like that
because they did not want the firefighter to make the decision,
now we go back to what we were saying at the battlefield. You
can have now somebody remotely really helping on an emergency
where something like that has to happen. As far as this group
helping us and how we can have more adoption on cellular phones
and smartphones, well, we are the silent partner of the
patient. We support the caregiver, so I am more about the
physicians being able to get access to the data for all the
patients anywhere at any time. So anything that can support
caregivers to be able to do care coordination through mobile
coordination, I think it is the area where we need the most
help. And reimbursement on the Medicare and Medicaid side is
very important for that.
Mr. BURROW. Thanks for that question. It is true that not
everybody has a smartphone, although that is changing rapidly.
In communities that have disadvantaged individuals where
economics may not be there, we have been amazed at how many
people, particularly of the younger generation, do, in fact,
have smartphones. And as we have all learned, more people use
smartphones now to access the Internet than use the PC. This is
extraordinary. We have just gone through an amazing inflection
point there.
So what we observe--this is anecdotal--is that individuals
who accompany their mother to the hospital and they have a
smartphone with the record on the smartphone, this is an
extraordinary thing for individuals who might not be able to
answer the questions--what are your medicines? Who are your
doctors? What are your problems? And even individuals who do
not speak English, if they have our record in English right
there and they can show it to the doctor, this is really,
really something. And so we think that this kind of technology
is very important for the communities that you are referencing.
Mr. BROPHY. We have seen the proliferation of the mobile
technologies is exploding. Even as it has already reached this
inflection point it continues to go up, up, up, and a solution
like ours can not only run on a smartphone but also on tablets,
mini-tablets, anywhere that there is wireless where we have
supported the application. Often the insurance companies will
provide the device themselves to the populations, whether it is
to children with severe asthma or senior citizens with heart
conditions if they do not have a smartphone of their own
because the expected cost savings are so significant, the cost
of the device pales in comparison.
We also designed a solution so it does not require
pervasive Internet; it requires occasional Internet, and we
have scenarios where users that do not have access to every day
Internet go to a library, to a school setting, to their local
restaurant and upload the data. So there is a variety of
approaches we have used.
In terms of what could help looking to the future, I would
just underscore that bandwidth is beautiful and a nation with
great bandwidth is a strong nation today.
Ms. HAHN. Actually, my facts are that 132 million Americans
do not own a smartphone right now. So that is a lot of folks.
And even when you look at, for instance, AARP magazine--I am a
member, I am not embarrassed--their advertisements are for the
Jitterbug. Right? So there is not this, you know, our senior
population is not embrace. Maybe the young people are clearly
but the seniors, particularly those who are disadvantaged are
really considering this probably a luxury that they cannot
afford. So I hope we can figure out a way to not leave that
many Americans behind as we embrace this new technology.
Thank you, Mr. Chairman. I yield back.
Chairman COLLINS. Well, I want to thank all of our
witnesses for participation today. I mean, certainly, what we
have seen is entrepreneurship at its best, and I think we do
rely on small business. They are 60 percent of the employees
today, and will be, I think, 80 percent of the new jobs created
in America. And it is that entrepreneurship that we see here is
alive and well.
Bringing forth solutions in some cases to problems people
did not know they had, but as you have demonstrated today,
these solutions are somewhat common sense, but they are only
common sense after you discover them. And then as you present
them, parents are saying, well, of course I would like to be
able to monitor my child's behavior, whether they are diabetic
or they have asthma, you know, for the comfort of mind. All of
us with aging parents want to be able to know that we know what
they are doing and that the doctors know, because they do go to
different pharmacies, they go to different doctors, and we all
worry about that. What you have done today, I think, has helped
describe where this is going, and anytime you are on the
cutting edge, which we are today, there will be bumps in the
road, but I think your testimony was good and very informative
to all of us. So thank you for your time.
I would like to ask unanimous consent that the members have
five legislative days to submit statements and supporting
materials for the record. Without objection, so ordered.
The hearing is now adjourned.
[Whereupon, at 11:26 a.m., the Subcommittee was adjourned.]
A P P E N D I X
Prepared Statement
of
Mr. Alan Portela
Chief Executive Officer, AirStrip
``MOBILE MEDICAL APP ENTREPRENEURS:
CHANGING THE FACE OF HEALTH CARE.''
BEFORE THE
HOUSE COMMITTEE ON SMALL BUSINESS
SUBCOMMITTEE ON HEALTH AND TECHNOLOGY
JUNE 27, 2013
Chairman Collins, Ranking Member Hahn and members of the
Subcommittee, thank you for the opportunity to appear before
you today to discuss mobile health (mHealth) and current
regulations that surround it.
Over the last 20 years, information management and
information technology have played a transformative role in
shaping the future of healthcare. Current and future
innovations in healthcare information technology (HIT) will be
no different and they will affect very facet of healthcare
including how it is delivered, how it is consumed, how
hospitals compete with one another to provide best value and
how the healthcare labor force is realigned to meet ever-
changing requirements.
The nation's healthcare system is undergoing a significant
transformation. The move from an ``Episode of Care'' (Fee for
Service) to an ``Outcomes Improvement'' (Bundled Incentives and
Payments) model is forcing healthcare organizations to look
beyond the four walls of the hospital and into a ``Patient
Centered Home Care'' model.
As a result of this change, the attention is moving from
the inpatient (hospital) to the outpatient care settings
(ambulatory, home, etc.). The focus is turning to all
activities around outcomes improvement throughout the continuum
of care in order to avoid unnecessary hospital stays and re-
admissions.
The model is becoming more patient-centric and, at the same
time, the consumer's level of sophistication is increasing the
competition amongst providers who are quickly seeking
differentiators by acquiring both specialists (primarily
cardiologists and endocrinologists/diabetes specialists) and
leading-edge technologies that can have a direct impact on
chronic disease management. The competition generated as a
result of this trend is becoming fierce; payers are embracing
ACOs and negotiating lower reimbursement, while providers are
aligning clinical service lines with quality and costs.
These changes and challenges faced by the healthcare system
have been exacerbated as the Baby Boomer generation is reaching
retirement age and 16 million formerly uninsured additional
patients that will be added to the system as part of Healthcare
Reform. The change in scope (Patient Centered Model), coupled
with the current caregiver shortages the industry faces and the
move away from generalist doctors to specialists, will mean a
great reliance on mobile health and shared-medical
technologies. The major driver behind this transformation is
the prevention of disease and the management of chronic
diseases while reducing costs. Approximately 75% of the US
population has at least one chronic disease, with
cardiovascular diseases representing three of the top five
(COPD, hypertension, cardiac heart failure, diabetes and
stroke).
The focus on outcomes is forcing healthcare organizations
to concentrate their strategic initiatives around federal and
private sector reimbursement and incentive payment programs
designed to support regional management of those chronic
diseases (Accountable Care Organizations or ACOs, Meaningful
Use and other similar payer programs). A key initiative is to
attract a larger patient population by tapping into the
regional specialist (i.e. cardiologist), partnering with other
regional providers as well as the use of social media to reach
out to the community.
Hospitals will need help as they move from a fee-for-
service to a fee-for-value model since they are the ones
leading the paradigm. They've been focused on core operations
in the hospital and not so much on the pre-hospital or post-
hospital care. Integrated Delivery Networks (IDNs) are back to
buying up physician groups as they were during the managed care
days, but there is a much different motivation for doing it
today. In order to integrate to a more collaborative model,
they're going to need the type of technologies that will enable
them.
Unfortunately, providers have been significantly reducing
personnel in the inpatient areas, with massive layoffs starting
in the second half of 2011 in anticipation of expected
reimbursement cuts. In our opinion, this is not the right
approach to take since it will only make things worse. Our
approach is validated by new research from the New England
Journal of Medicine suggesting that as hospitals prepare for an
additional 16 million newly insured patients in 2014, they
should be concentrating on adding more support staff to support
specialists. The reasoning is that aside from providing care to
newly insured patients, not only within the hospitals but also
throughout the continuum of care, hospitals will need support
staff to process applications, file insurance claims, submit
data for regulatory compliance, and perform other
administrative duties, according to the study.
Mobile technology will play a crucial role in the
development of new federal and private reimbursement revenue
models that can improve the quality of care, reduce costs,
prevent job losses and create new, more specialized healthcare
jobs.
Today, large integrated delivery networks are exploring
reimbursement models focusing on the adoption of technology to
improve workflow and generate revenues around clinical services
such as cardiology and diabetes. Payers are also following
these models, realizing that the shift will occur with or
without the momentum created by the federal government around
Medicare and Medicaid programs and ACOs. Payers leading the way
include Aetna, United, and Humana.
As previously stated, for the past decade, the healthcare
industry has faced an ongoing shortage of caregivers impacting
physician labor force distribution. Under the new labor model,
primary care generalists are disappearing, replaced by
specialists who are breaking down work previously done by one
person into more specialized tasks performed by experts.
Doctors will no longer be paid by the episode of care, but
rather by their expert interpretation of raw clinical data as
well as improved outcomes. Relevant data will need to follow
the physicians wherever they go, rather than bringing them to
the data residing in one central location. At this point,
technology becomes essential to support the new reimbursement
and financial models. That includes mobile technology,
analytics, and cloud computing.
As a result, physicians no longer practice medicine in one
location. They are fast becoming mobile professionals, with
mobile technology including tablets and smartphones developing
as the ultimate tool to improve workflow under the new models.
Labor force changes include:
Primary care generalists are decreasing by
alarming rates.
Rapid rise of hospitalists, who now account for
approximately 40% of hospital admissions (55% from the
emergency department and rest via primary care physicians).
The shift to an ambulatory care model (home) will
only add to the shortage since care was primarily provided
within the four walls of the hospital.
Hyper-specialization, which is increasing around
new service line reimbursement models (i.e. cardiologists,
endocrinologists, oncologists, etc.).
The Rise of the Virtual Specialist
Hyper-specialization requires technology to create virtual
environments. The shift of medicine to outcomes improvement and
care beyond the four walls of the hospital will add a
significant burden to the existing shortage of caregivers.
Mobile technology that enables physician virtualization will be
critical moving forward.
Today, the biggest challenges in the advancement of Health
Information Technology (HIT) are security, limited access to
diagnostic quality solutions (FDA cleared or approved) and
medical device interoperability. AirStrip has decided to
proactively deal with the first two by seeking the highest
level of certification for our mobile medical device solutions
for security (DIACAP / Defense Information Assurance
Certification Accreditation Process / DoD) and for diagnostic
quality (FDA Class H, 510K). We are taking this proactive
approach because we feel strongly about the need for the FDA to
regulate (from both diagnostic quality and security
perspectives) mobile applications that handle vital information
for remote monitoring systems. Many vendors today are trying to
question the need for FDA involvement with an argument around
whether innovation is being slowed down or stifled outright.
The reality is that the same requirements influenced AirStrip's
innovative approach and today thousands of lives are impacted
as a result of a partnership between federal and private
sectors. Vendors opposing FDA involvement are concerned about
the medical device excise tax as well as the strict ``Good
Manufacturing Practices'' regulations without looking at the
quality of patient care. We on the other hand do not object to
the FDA requirements and involvement, but do not want to be
singled out (Excise Tax) for proactively partnering with the
Federal Government.
In July 2011, The House Energy and Commerce Committee's
sent questions to FDA seeking much-needed clarification on the
agency's policy of regulating certain mobile medical apps as
medical devices. I was pleased to see the FDA respond to
attempts to clarify the ``gray area'' of the guidance it issued
in July 2011. Moving forward, the FDA should immediately
release the Final Mobile Medical Applications Guidance Document
and take the following patient safety issues into
consideration:
All mobile medical device applications displaying
near and real time medical device waveforms and parameters data
need careful regulation - Traditionally, the FDA has focused on
regulating hardware devices, but companies producing software-
only medical device apps or even websites need to be regulated
as well. Today, many websites or apps have crept into FDA-
regulatory territory without scrutiny by adding features or
functionality that position them as clinical decision support
systems. For example, a website where vital signs, demographic
data or physiological observations are used to power a decision
flowchart that guides diagnoses can easily extend out to a
mobile platform. That, in essence, creates a medical device
that is conducting clinical support, and should be regulated.
``Accessories'' to primary devices should also be
evaluated - Currently, software ``accessories'' (as the FDA
terms them) to primary devices do not require separate
clearance by FDA. Not only could the network go down, but the
mobile medical device itself could be overloaded or failing in
other ways. The FDA needs to also consider these accessories
and potential failure points to ensure that manufacturers have
addressed those issues in their testing.
Mobile applications capable of displaying mission-
critical patient data should obtain security certification
levels that go beyond the existing HIPAA requirements and FCC
security regulations (Open SSL). Patients privacy and security
are also important to ensure FDA's goal of safety and efficacy
of medical devices. The DoD's security certification process
should be used as an example and cross-pollinate to the private
sector.
The industry is greatly benefiting from mobile
applications, but not all applications are created equal in
terms of risk. Given the number of applications claiming to
exchange or display patient data, the FDA should include many
more mobile medical device apps under its jurisdiction.
Our approach to address interoperability has been around
complying with interoperability standards - HL-7, Continuity of
Care Document CCD and others.
Interoperability of health information has been heralded
for decades as a way to make medicine more effective,
efficient, and safer. However, the interoperability challenge
has plagued hospitals and health systems for longer than any of
us care to admit. The industry has largely over-promised and
under-delivered when it comes to vendors ``playing nice in the
sandbox,'' integrating systems, medical device interoperability
and making data across the continuum available in a simple and
cost-effective way.
The answer to this challenge is mobility. With today's
changing models of care, mobility enables coordination across
multiple facilities and geographics, as clinicians increasingly
need to make or discuss real-time decisions beyond the bedside.
Mobility also overcomes what we've always known as the
traditional barriers to interoperability - disparate data
sources on the back end and conflicting and varied user
preferences on the front end. In the race to accountable care,
where health care organizations are being forced to figure out
how to reduce costs and improve outcomes in record time,
mobility is the first and fastest enabler of clinical
integration and transformation. Without it, accountable care
cannot be achieved.
However, even mobility vendors haven't gone far enough in
addressing interoperability. We've attacked different pieces of
the puzzle, understanding that we need to prove value and
return on investment, but we are ready for the next step. When
CEOs and CIOs of major hospitals witness the unifying power of
mobility in areas like cardiology and obstetrics, beyond
enabling them to make strides around specific quality metrics
like door-to-balloon time or patient satisfaction, they are
recognizing its potential to achieve clinical transformation
throughout the entire health system. I've already seen this
start to happen in the health systems I visit every day. This
signals to me that mobility has been proven, and the industry
is ready to take an enterprise-wide approach. We are entering
an era in which health systems view mobility as a necessity for
the entire care continuum.
A world where interoperability is achieved through mobility
should not only provide secure, near-real-time data about a
patient from any source across the care continuum - from admit
to discharge and beyond - but it should also offer the ``big
picture'' data health systems need to make broader decisions
about their operations and ultimately, their financial future.
This will mean that health systems can finally make the shift
from focusing on incremental or departmental operational
changes to true transformational change that enables them to
meet the broader demands of the new healthcare environment -
improving population health and addressing pressing issues such
as reducing readmissions.
Clinicians no longer work in stationary environments, but
rather are frequently required to move across facilities and
departments. To provide care to patients regardless of
location, physicians need the data available whether they are
at the bedside, down the hall or at a different hospital. For
now, interoperability will continue to be a challenge in the
future of HIT, but it is clear to me where the industry is
headed. Mobility is the lynchpin, and we are not far from every
hospital and health system's ``a-ha moment.''
I am often asked by hospitals CEOs and CIOs how they should
prioritize mobility when it comes to different care areas. My
first answer is to look at your current challenges and
strategic initiatives, and then ask how mobility can help you
to get there. While I always emphasize the benefit of mobility
across all departments, cardiology is where I see the potential
for mobility to make the most immediate impact - especially
when it comes to improving outcomes and reducing readmissions.
Door-to-balloon time is one of the most significant metrics
regarding cardiology. Today, the average in the U.S. is about
90 minutes. But when you equip cardiologists with diagnostic-
quality ECGs coming right from the ambulance, they are able to
make decisions immediately, saving valuable minutes and giving
them the option to bypass the emergency department to send
patients directly to the cath lab. I've seen hospitals drive
door-to-balloon time down to 35 minutes. On the flip side, a
hospital loses $7,500 every time they unnecessarily put
together a cath lab team. Thus, the sooner clinicians can
identify and communicate a false STEMI, the more savings the
health system will see.
More importantly, reducing event-to-balloon time also puts
patients in the ICU with less damage to their hearts and who
are ultimately ``healthier' on their road to recovery. I've
seen hospitals shave nearly a day from their post-STEMI ICU
stays, which saves anywhere from $1,400 to $2,500 per patient.
Over the course of a year, a hospital that cares for 200 post-
STEMI ICU patients could see a savings of at least $280,000.
This leads me to cardiology-related readmissions, which are
under the most scrutiny with the CMS penalties enacted by the
Affordable Care Act (ACA) where hospitals can be docked up to 1
percent of Medicare DRG payments around acute myocardial
infarction (AMI) and heart failure (HF). In general, patients
who experienced a shorter event-to-balloon time and shorter ICU
stay are much less likely to return with complications within
30 days. But there is even more to that story. For one
hospital, we looked at 100 ECGs of discharged patients and
noticed that a significant percentage of those patients had
difficult-to-detect conditions when discharged, and therefore
ended up coming back within 30 days. This was because those
patients had a heart condition or weakness that was not
detected by the physicians on the floor - because not all of
them were cardiologists. Electro-physiologists and
cardiologists need to be able to review patient data from
anywhere to identify issues and prevent patients from leaving
the hospital without proper care.
Mobility also plays a key role in the critical post-
discharge period for heart failure patients. They can be sent
home with sensors that are constantly uploading ECGs and other
data that can be accessed by a group of electro-physiologists
and cardiologists, who in turn identify and ideally prevent
potential causes for readmission. A two-year study of patients
with congestive heart failure (CHF) showed a 44% drop in
readmissions through the use of home telemonitoring. If a
patient can go directly to the cath lab rather than the ED
because a physician is able to remotely diagnose the condition,
then the hospital is not penalized for a readmission under the
ACA. And the physician doesn't need to be at a desktop in the
hospital to make that happen. Not only that, when an electro-
physiologist needs to consult with a cardiologist about a
patient, the two can review the same ECG in virtually real-time
on an iPad or other mobile device in two different locations.
The benefits of a mobility platform in every department
across a health system are too significant to ignore, but with
its time-sensitive and care-intensive environment, cardiology
represents the most immediate opportunity for mobility to make
a positive impact on both patient care and a hospital's bottom
line. The management of other chronic diseases (i.e. diabetes,
COPD, etc.) via mobile devices should be placed in the same
category in order to quickly impact the quality of care.
I am honored to have the opportunity to be a part of the
mobile healthcare industry, a partner with the federal
government and even more so to be part of the exciting
innovations which will deliver better patient care and better
patient outcomes, now and in the future.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
METRIX
Testimony of Christopher R. Burrow, M.D.
Before the
Subcommittee on Health and Technology
Small Business Committee
U.S. House of Representatives
Hearing on
``Mobile Medical App Entrepreneurs: Changing the Face of Health Care''
June 27, 2013
Chairman Collins, Ranking Member Hahn, and distinguished
subcommittee members, thank you for the opportunity to appear
before you today to discuss mobile medical applications and
their impact on the U.S. health care system. My name is Dr.
Christopher Burrow, and I am the Executive Vice President for
Medical Affairs at Humetrix, a small, woman-owned business in
Del Mar, California. Prior to my current role at Humetrix, I
was an executive and founder, respectively, of two California
start up biotechnology companies that developed new
cardiovascular disease diagnostic tests. As a physician-
scientist, I have two decades of experience both as an
attending physician in Nephrology/Internal Medicine and as a
molecular biologist. Humetrix's CEO, Founder and President is
Dr. Bettina Experton, a former California Public Health Officer
who conducted groundbreaking health services research on the
impact of managed care on the frail elderly in the Medicare and
Medicaid programs. Humetrix is a member of the App Developers
Alliance, an industry association dedicated to meeting the
needs of developers as creators, innovators and entrepreneurs,
and we appear here today on their behalf.
Leveraging Patient-Facing Technology to Improve Health Care
Founded in 1998, Humetrix has been a pioneer in the
development of mobile technology. At Humetrix, we believe that
tools and mechanisms that enable increased engagement by
patients and their caregivers have the potential to transform
the delivery of health care. Indeed, over the last fifteen
years, we have developed numerous mobile applications that
enable consumers to engage with the world around them in new
and innovative ways.
Despite the significant progress in electronic health
record (EHR) adoption made as a result of the Health
Information Technology Economic and Clinical (HITECH) Act
(included as part of the American Recovery and Reinvestment Act
(ARRA) of 2009), essential health information is not readily
accessible by patients in today's provider-centric health care
system. In 2011, only 31 percent of physicians were capable of
exchanging a patient's health information with another
provider.\1\ Given that the average Medicare beneficiary sees
seven providers a year, the odds that all of a given Medicare
patient's providers are able to exchange records could be as
low as 2 in 10,000. A typical physician treating a Medicare
patient must coordinate care with an average of 229 physicians
in 117 practices.\2\
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\1\ Federal Register, Volume 78, Number 45 (March 7, 2013), pages
14793-14797 http://www.gpo.gov/fdsys/pkg/FR-2013-03-07/html/2013-
05266.htm
\2\ Pham HH et al. 2009 Primary care physicians' link to other
physicians through Medicare Patients Annals of Internal Medicine 150:
236-242 and Pham HH et al. 2007 Care patterns in Medicare and their
implication for pay for performance NEJM 356: 1130-1139
The gaps and limitations of provider-based health
information exchange solutions - through which one EHR system
connects to another EHR system, either directly or using
supporting tools and technical infrastructure - present a
particularly critical challenge for the Medicare population
because these patients often transition between care settings
and may see multiple providers to address their chronic care
needs. Recent data shows that one in three Medicare patients
are discharged from a hospital to a long-term or post-acute
care setting.\3\ In many cases, little to no information
follows the patient to their new care setting, as the vast
majority of these facilities do not use EHRs and have no means
of electronic exchange, EHR-based or otherwise.
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\3\ Federal Register, Volume 78, Number 45 (March 7, 2013), pages
14793-14797 http://www.gpo.gov/fdsys/pkg/FR-2013-03-07/html/2013-
05266.htm
A lack of appropriate information at the point of care may
also negatively impact health care outcomes and increase health
care costs. Experts estimate that, in any given year, a lack of
accurate, comprehensive information about a patient's health
status and treatment results in the needless duplication of
laboratory tests, imaging studies and avoidable medical errors.
In its September 2012 report, Best Care at Lower Cost: The Path
to Continuously Learning Health Care in America, the Institute
of Medicine (IOM) recommended equipping patients with tools
that deliver ``reliable clinical knowledge'' so that they are
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able to fully participate in their own care, stating:
``Health providers should place a higher premium on
fully involving patients in their own health care to
the extent that patients choose. Clinicians should
employ high-quality, reliable tools and skills for
sharing decision making with patients, tailored to
clinical needs, patient goals, social circumstances,
and the degree of control that patients prefer . . .
CMS and other payers should promote and measure
patient-centered care through payments models,
contracting policies, and public reporting programs.
And digital technology developers and health product
innovators should develop tools to assist individuals
in managing their health and health care.'' \4\
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\4\ Institute of Medicine, Best Care at Lower Cost The Path to
Continuously Learning Health Care in America (September 6, 2012); Mark
Smith et al., editors. National Academies Press.
My testimony today will demonstrate how Humetrix is using a
federal initiative called ``Blue Button'' to realize the IOM's
vision of consumer-centric care. By enabling patients to access
to their own health information at the point of care with an
easy-to-use mobile application, Humetrix's solution is free
many of the challenges encountered by current provide-centric,
system-to-system health information exchange initiatives. We
believe that leveraging consumer-driven mobile technology at a
large scale could transform health care by serving as a
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powerful care coordination tool and improving patient safety.
iBlueButton as a Case Study
The Federal Blue Button initiative was launched by
President Obama in 2010. The idea was simple: given patients
access to their own health information using an easy-to-
identify symbol that could be adopted and used by any
organization holding valuable patient date - a blue button. The
initiative saw results quickly. Just three months after its
launch at the Department of Veterans Affairs (VA), more than
60,000 veterans had already used it to download their personal
health information. Today, more than 100 million Americans have
access to Blue Button data through the VA, the Department of
Defense (DoD), the Centers for Medicare & Medicaid Services
(CMS), or a private health plan.
Humetrix recognized the transformative potential of Blue
Button data early on and saw an opportunity to build on Federal
initiatives by leveraging the extraordinary power of mobile
devices, particularly smart phones and tablets. Current data
shows that 61 percent of American mobile phone users, or 139
million individuals, have a smart phone.\5\ Increases in
smartphone usage for health care management have been seen in
all demographic and ethnic groups, including the 55+ age
bracket.\6\
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\5\ Available here: http://www.nielsen.com/us/en/newswire/2013/
mobile-majority--u-s--smartphone-ownership-tops-60-.html
\6\ Available here: http://www.pewinternet.org/Reports/2012/Mobile-
Health.aspx
As greater numbers of consumers become increasingly
comfortable using their mobile devices to securely conduct
sensitive transactions (e.g., online banking and other e-
commerce transactions), health care will need to adapt to meet
consumer expectations. Humetrix believes that the most
efficient, cost-effective mechanism of health information
exchange relies on mobile technology to ensure that patients
and their providers are able to securely access their medical
records whenever and wherever they need to. As such, we have
created the iBlueButton iOS and Android apps to provide
patients and caregivers with easy, reliable and secure access
to their health record, as maintained by both private and
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public payers.
Humetrix began its development of the smart phone
iBlueButton app series in Spring 2011; we have been
continuously upgrading our apps since that time to provide ever
increasing utility to our end users. In June 2012, Humetrix
entered the Investing in Innovation (i2) ``Blue Button Mash Up
Challenge'' sponsored by the U.S. Department of Health and
Human Services' Office of the National Coordinator for Health
Information Technology (ONC). The goal of this challenge was to
inspire developers to create an easy-to-use, patient-friendly
application that combined Blue Button personal health record
data with other data sources designed to improve care, improve
health and reduce costs.
After a rigorous peer-review process by a panel of
patients, vendors, and developers, ONC announced that Humetrix
was the winner of the i2 Blue Button Mash Up Challenge.
Humetrix's iBlueButton application transforms the beneficiary-
level claims data currently produced by CMS into a secure, user
friendly, longitudinal health record that can be accessed on a
mobile device and exchanged by patients and providers at the
point of care.
Because CMS makes up to three years of claims information
available to each of its beneficiaries, the Medicare Blue
Button record is often unwieldy and of limited utility to a
patient or their physician; for even simple cases, the record
can easily reach dozens or even hundreds of pages in length for
a single patient.
However, once a record has been generated, iBlueButton
transforms the hard-to-understand list of coded claims in the
Medicare Blue Button record into a patient friendly, 3-year
longitudinal clinical record. This comprehensive health record
can be viewed directly on a smart phone or tablet, and contains
a patient's key health information such as problem and
medication lists, as well as a detailed history of all the
patient's health care encounters, including inpatient
admissions, outpatient visits, imaging services, labs, and
procedures. Medicare beneficiaries can review their
information, annotate their records with additional details,
and look up information about medications and potential adverse
reactions or medical problems using MedlinePlus, an online
reference resource maintained by the National Library of
Medicine. Medical records are stored on the smart phone using
state of the art encryption, and cannot be accessed by others
in the event that the smart phone is lost or stolen.
In addition, the iBlueButton app also enables the patient,
or their caregiver, to securely transfer the Blue Button record
to a physician's tablet running the companion iBlueButton
Professional app. Using the iBlueButton Professional app, the
provider is able to view the patient's records, as well as any
annotations made by the patient about their medications,
potential side effects they may be experiencing, and their
medical conditions.
The iBlueButton app is currently available to consumers
directly from the iTunes or Google Play stores, providing
millions of fee-for-service Medicare beneficiaries and/or their
caregivers the ability to have mobile, secure, immediate access
to critical medical information.
Realizing the Potential to Change the Face of Health Care.
Humetrix believes that existing mobile infrastructure and
increasingly ubiquitous mobile consumer devices must be
leveraged to provide patients and their caregivers access to
essential health information at the point of care. Indeed,
tremendous benefits could result from strategies that enable
better exchange of health information in the health care system
using the Blue Button record. Providers could use the record to
identify previous misdiagnoses and medications prescribed in
error, as well as other misinformation. They may also use the
comprehensive information contained in the record to eliminate
unnecessary tests and prevent adverse drug reactions, which
result today when a new prescription interferes with an unknown
existing medication. Patients may even use the Blue Button
record to detect fraudulent or erroneous claims, and break down
existing language or health literacy barriers.
The real-world impact of this technology was highlighted by
Christine Bechtel, former Vice President at the National
Partnership for Women & Families, during her March 20, 2013
testimony before the House Energy and Commerce Committee's
Health Subcommittee. She relayed a story told by a woman who
experienced the true value of Blue Button, and iBlueButton in
particular, when caring for her father, a Medicare beneficiary:
``The hospital had an old record showing he had a
diagnosis that required him to take Coumadin, which is
a blood thinner. And because I had the [Blue Button]
data in my hands, I could show them that he was no
longer on that medication, and that truly was
instrumental in saving his life. Within hours of his
discharge he fell and suffered severe head and arm
lacerations that would have been life threatening had
he been on Coumadin and would have resulted in a
readmission within just five hours of discharge.'' \7\
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\7\ Available here: http://www.nationalpartnership.org/site/
News2?page=NewesArticle&id=38627
To ensure that these benefits are realized on a large-scale
by patients and caregivers across the country, policies and
regulations should be structured to support continued
innovation in mobile health technology. Many organizations,
including the App Developers Alliance, have established
principles and policy recommendations for the fair regulation
of mobile medical apps. These principles may be informative as
policymakers continue to consider how to support mobile access
to health information as a key component of improving the
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safety and cost-effectiveness of health care.
Furthermore, additional work must be done to educate
consumers and providers alike about the value of consumer-
driven health information exchange using the Blue Button
record. Although significant progress has been made in certain
patient populations, including veterans, intensive outreach and
education efforts are needed by Federal and private payers
alike to ensure that their beneficiaries have access to and
understand how to use technologies like iBlueButton. Likewise,
large-scale provider outreach is needed to train providers on
the value of using these technologies at the point of care and
to provide them with the information needed to educate their
patients on the use of mobile apps for management of their own
health and health care.
In closing, I would like to thank Chairman Collins, Ranking
Member Hahn, and all of the members of the subcommittee for the
invitation to testify today about this important topic. I look
forward to answering your questions.
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Chairman Collins and distinguished members of the
Subcommittee, thank you for the invitation to participate in
today's hearing. My name is Sabrina Casucci and I am a PhD
Candidate in Industrial and Systems Engineering. As a PhD
candidate my recent research has focused on modeling healthcare
processes. As an entrepreneur, I seek to apply this theoretical
learning to develop more effective healthcare delivery
solutions. I am honored to represent a talented team of fellow
graduate students from the University at Buffalo Department of
Industrial and Systems Engineering.
Our team members are: Dapeng Cao, Theresa Guarrera, David
LaVergne, Nicolette McGeorge, Judith Tiferes-Wang, and Yuan
Zhou. Dr. Li Lin, a professor in the Department of Industrial
and Systems Engineering at University at Buffalo, SUNY, is a
valued mentor in on our ongoing development activities.
Our group of young entrepreneurs are translating our
individual healthcare and technology related research into a
mobile solution that will make hospital discharge planning a
more effective and efficient process. Ultimately we seek to
reduce readmission rates by facilitating communication among
patients, their family, and clinicians, improving patient and
family preparation for post hospital care and ensuring
continuity of care with community based care providers.
I would like to briefly discuss the critical aspects of our
work, including the fundamental problem of readmissions that we
are trying to address, our mobile solution, and the
difficulties that we will face on our development journey. The
need for improved tools that fundamentally address the issues
inherent in existing healthcare processes is great. Increased
governmental and industrial support for start-up organizations
and health care researchers like us is needed, as is increased
federal support of interoperability standards that enable
communication between different Information Technology systems.
The discharge planning process is a critical step in acute
patient care. However, the inherent complexity of existing
processes and the lack of a standardized approach often result
in undesirable outcomes for the health care system and the
patient. As a result, nearly 1 in 5 Medicare patients are
readmitted to a hospital within 30 days of their initial
discharge. This negatively effects individual patient health
and places a huge financial burden on the US healthcare system.
Potentially avoidable readmissions of Medicare patients are
estimated to cost more than 17 billion dollars annually.
Despite recent efforts to reduce readmission rates and costs of
care, annual readmission rates have remained relatively
constant.
The effects of poorly executed care transitions on the
patient and their family is equally important as studies have
shown that more than 40% of high risk elderly patients have
experienced one or more problems post discharge, including
readmissions. Further, patients and their families often feel
frustrated, confused, or otherwise unable to manage their care.
Our solution connects personal mobile devices with Health
Information Technology to improve patient outcomes and reduce
healthcare expenditures by redefining the patient discharge
process. Our systemic approach provides personalized tools for
patients, their family, and clinicians that enable informed
decision making and improved continuity of care.
Solutions like ours can make a significant impact on
healthcare in the US. Mobile solutions can connect fragmented
care processes and improve continuity of care, both
contributors to improved patient outcomes and reduced care
costs.
The idea for the Discharge Roadmap app was developed, in
part, due to my own personal experiences. In the past few years
my mother has served as an informal caregiver for several
elderly relatives, most of who are older than 90 years of age.
She has had to manage her own career and health needs as well
as the complex needs of this generation. When three relatives
were recently and simultaneously hospitalized she spent
countless hours on the phone and missed several days of work to
ensure their post discharge care needs were met. Navigating
three different discharge processes was an arduous task and it
was clear that better solutions should be possible.
The opportunity to develop a tool that addresses these
difficulties came in November of 2012 when GE Healthcare
launched the Health Quest competition. Teams were challenged to
develop new mobile healthcare apps that would improve the
hospital experience for patients and their families. The
competition presented the catalyst needed to develop Discharge
Roadmap, which we believe will fundamentally redefine the
discharge planning process.
As a start-up organization we know there is a long and
difficult journey ahead of us. However, there are many groups
of talented and dedicated researchers and entrepreneurs
throughout the US working to develop solutions to these complex
healthcare problems. The opportunity to (i) positively affect
healthcare in the US, (ii) reduce readmission rates, (iii)
lower healthcare costs, and (iv) alleviate the anxiety and
burden of discharge planning for patients and their families,
compel us to overcome these challenges.
In order for technology-enabled solutions, such as
Discharge Roadmap, to succeed, the solutions must be able to
communicate with existing hospital information systems.
However, the current lack of a unified data structure and
communication protocols severely limits this communication
ability. Improving interoperability will ensure that healthcare
providers can choose a solution that best fits the needs of
their patients, and not just the needs of their current health
information technology systems.
As a start-up organization we are in the early stages of
developing our mobile solution and are eager to continue the
process. We believe our app will alleviate the burdens imposed
on patients, their families, and clinicians in this critical
process. We seek to make a meaningful contribution to reducing
readmission rates by providing patients, their families, and
hospital based clinicians with a clear communication channel
and by improving continuity of care with community based care
providers.
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