[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.

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                               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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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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