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21ST CENTURY TECHNOLOGY FOR 21ST CENTURY 

CURES 

JOINT HEARING 

BEFORE THE

SUBCOMMITTEE ON COMMUNICATIONS AND 

TECHNOLOGY 

AND THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

JULY 17, 2014 

Serial No. 113–162 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

JOHN A. YARMUTH, Kentucky 

(II) 

(III) 

SUBCOMMITTEE ON COMMUNICATIONS AND TECHNOLOGY

GREG WALDEN, Oregon 

Chairman 

ROBERT E. LATTA, Ohio 

Vice Chairman 

JOHN SHIMKUS, Illinois 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

MARSHA BLACKBURN, Tennessee 

STEVE SCALISE, Louisiana 

LEONARD LANCE, New Jersey 

BRETT GUTHRIE, Kentucky 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

ANNA G. ESHOO, California 

Ranking Member 

MICHAEL F. DOYLE, Pennsylvania 

DORIS O. MATSUI, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

JOHN D. DINGELL, Michigan 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

DIANA DEGETTE, Colorado 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

HENRY A. WAXMAN, California (ex officio) 

SUBCOMMITTEE ON HEALTH

JOSEPH R. PITTS, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

CATHY MCMORRIS RODGERS, Washington 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

FRANK PALLONE, JR., New Jersey 

Ranking Member 

JOHN D. DINGELL, Michigan 

ELIOT L. ENGEL, New York 

LOIS CAPPS, California 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

GENE GREEN, Texas 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

HENRY A. WAXMAN, California (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Greg Walden, a Representative in Congress from the State of Oregon, 

opening statement ................................................................................................ 1 

Prepared statement .......................................................................................... 3 

Hon. Frank Pallone, Jr., a Representative in Congress from the State of 

New Jersey, opening statement .......................................................................... 3 

Hon. Joseph R. Pitts, a Representative in Congress from the Commonwealth 

of Pennsylvania, opening statement ................................................................... 5 

Prepared statement .......................................................................................... 5 

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, opening statement .................................................................................... 9 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 10 

Prepared statement .......................................................................................... 11 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 11 

WITNESSES

Dave Vockell, Chief Executive Officer, Lyfechannel, Inc. .................................... 12 

Prepared statement .......................................................................................... 15 

Answers to submitted questions 1 ................................................................... 94 

Dan Riskin, Founder, Health Fidelity ................................................................... 21 

Prepared statement .......................................................................................... 23 

Answers to submitted questions ...................................................................... 95 

Paul Misener, Vice President, Global Public Policy, Amazon .............................. 29 

Prepared statement .......................................................................................... 31 

Answers to submitted questions ...................................................................... 109 

Robert Jarrin, Senior Director, Government Affairs, Qualcomm Incorporated .. 40 

Prepared statement .......................................................................................... 42 

Answers to submitted questions ...................................................................... 114 

Jonathan M. Niloff, Vice President and Chief Medical Officer, McKesson 

Connected Care & Analytics ............................................................................... 56 

Prepared statement .......................................................................................... 58 

Answers to submitted questions ...................................................................... 120 

SUBMITTED MATERIAL

Letter of July 16, 2014, from Grant Seiffert, President, Telecommunications 

Industry Association, to subcommittee leadership, submitted by Mr. Pitts ... 7 

Article of June 17, 2014, ‘‘Coalition Calls for Action Against EHRs That 

Block Interoperability,’’ iHealthBeat, submitted by Mr. Gingrey .................... 78 

1Mr. Vockell did not answer submitted questions for the record by the time of printing. 

(1) 

21ST CENTURY TECHNOLOGY FOR 21ST 

CENTURY CURES 

THURSDAY, JULY 17, 2014 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON COMMUNICATIONS AND TECHNOLOGY, JOINT WITH THE

SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittees met, pursuant to notice, at 9:33 a.m., in room 

2123, Rayburn House Office Building, Hon. Greg Walden (chairman of the subcommittee of Communications and Technology) presiding. 

Members present: Representatives Walden, Upton, Barton, 

Shimkus, Pitts, Terry, Burgess, Blackburn, Gingrey, Scalise, Latta, 

Lance, Cassidy, Guthrie, Gardner, Kinzinger, Griffith, Bilirakis, 

Long, Ellmers, Waxman, Pallone, Eshoo, Green, DeGette, 

Butterfield, Barrow, Matsui, and Braley. 

Staff present: Clay Alspach, Chief Counsel, Health; Gary Andres, 

Staff Director; Ray Baum, Senior Policy Advisor/Director of Coalitions; Sean Bonyun, Communications Director; Matt Bravo, Professional Staff Member; Leighton Brown, Press Assistant; Noelle 

Clemente, Press Secretary; Andy Duberstein, Deputy Press Secretary; Paul Edattel, Professional Staff Member, Health; Gene 

Fullano, FCC Detailee; Kelsey Guyselman, Counsel, Communications and Technology; Sydne Harwick, Legislative Clerk; Robert 

Horne, Professional Staff Member, Health; Grace Koh, Counsel, 

Communications and Technology; Carly McWilliams, Professional 

Staff Member, Health; David Redl, Chief Counsel, Communications 

and Technology; Charlotte Savercool, Executive Assistant, Legislative Clerk; Heidi Stirrup, Policy Coordinator, Health; John Stone, 

Counsel, Health; Jean Woodrow, Director of Information Technology; Ziky Ababiya, Democratic Staff Assistant; Eric Flamm, 

Democratic FDA Detailee; Karen Lightfoot, Democratic Communications Director and Senior Policy Advisor; Margaret McCarthy, 

Democratic Professional Staff Member; Rachel Sher, Democratic 

Senior Counsel; Matt Siegler, Democratic Counsel; and Ryan 

Skukowski, Democratic Policy Analyst. 

OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Mr. WALDEN. We are going to call the hearing to order. Thank 

you all for being here this morning. Good morning and welcome. 

Today, the Subcommittee on Communications and Technology and 

2 

Subcommittee on Health joint hearing on the ‘‘21st Century Technologies for 21st Century Cures.’’ I would like to thank all of our 

witnesses for testifying today. Your testimony is extraordinary and 

most helpful in our endeavors. 

When Chairman Upton and I announced that we would begin the 

process in updating the Communications Act, we knew it would be 

a difficult but much-needed process. So I am pleased today to be 

joining the Communications Act update with another important 

Energy and Commerce Committee initiative, 21st century cures, 

the communications and technology sectors that are an enormous 

boost to our Nation’s struggling economy due in part to the high 

investment and innovation in wireless technology and other devices. 

As we craft the legislation to update our laws, it is essential to 

hear from a wide variety of people who are on the front lines of 

developing and using these types of technologies in all spaces. 

Their unique viewpoints and expertise will help inform our consideration as we move forward, as well as underscore exactly why we 

have undertaken these challenging efforts to revamp existing laws. 

It makes sense to unite these two initiatives, as they are both 

critically important not only to industries that are crucial to the 

economy, but also for every person here. This is an opportunity to 

recognize the benefits wireless smartphones and devices can provide to improve an individual’s health and the healthcare community. 

We have seen examples of this intersection already from wearable devices that track activity, to the use of mobile apps reminding users of their individual health needs, to a patient’s ability to 

easily and remotely communicate with their doctor through a telehealth device. The growth in this area has been remarkable. There 

is a technological revolution happening in the healthcare space. 

In the communications and technology world, there has been a 

good deal of focus on the so-called virtuous cycle of technology; that 

is, the investment in devices and networks creates opportunities for 

app developers to create new and innovative uses for these devices, 

driving demand for consumers, which then spurs further investment. The healthcare technology field the perfect setting for this 

engine of invention and development. 

As healthcare technologies proliferate, patients, doctors and researchers will realize the potential for the technology, and as a result, demand will increase. Increased demand means even greater 

incentive for investors to place their bets on the technology, which, 

in turn, spurs the cycle even further. 

In reading the testimony submitted by our witnesses in advance 

of today’s hearing, I was impressed by what they can already do 

in the healthcare field using technology that exists and what the 

potential is as we develop. In Mr. Misener’s written testimony, he 

describes how leveraging cloud technology allowed scientists to conduct an experiment at a cost that was orders of magnitude less 

than it would have been using traditional data center and infrastructure. And I believe it was 39 years compressed into 9 hours. 

This is exactly what we are hoping to learn about today in more 

detail and how we can take advantage of these opportunities. 

With that, again, thank you for being here. 

3 

[The prepared statement of Mr. Walden follows:] 

PREPARED STATEMENT OF HON. GREG WALDEN

Good morning and welcome to today’s Subcommittee on Communications and 

Technology and Subcommittee on Health joint hearing, ‘‘21st Century Technology 

for 21st Century Cures.’’ I would like to thank all of our witnesses for testifying 

today on this timely topic. 

When Chairman Upton and I announced that we would begin the process of updating the Communications Act, we knew it would be a difficult, but much-needed, 

process. I am pleased today to be joining the Communications Act Update with another important Energy and Commerce Committee initiative, 21st Century Cures. 

The communications and technology sector has been an enormous boost to our Nation’s struggling economy, due in part to the high investment and innovation in 

wireless technology and other devices. As we craft the legislation to update our 

laws, it is essential to hear from a wide variety of people who are on the front lines 

of developing and using these types of technologies in all spaces. Their unique viewpoints and expertise will help inform our consideration as we move forward, as well 

as underscore exactly why we have undertaken these challenging efforts to revamp 

existing laws. 

It makes sense to unite these two initiatives, as they are both critically important 

not only to industries that are crucial to the economy, but also for every person 

here. This is an opportunity to recognize the benefits wireless smartphones and devices can provide to improve an individual’s health and the health care community. 

We have seen examples of this intersection already, from wearable devices that 

track activity, to the use of mobile apps reminding users of their individual health 

needs, to a patient’s ability to easily and remotely communicate with their doctor 

through a telehealth device. The growth in this area has been remarkable; there is 

a technological revolution happening in the health space. 

In the communications and technology world, there has been a good deal of focus 

on the so-called virtuous cycle of technology; investment in devices and networks 

creates opportunities for app developers to create new and innovative uses for those 

services, driving demand from consumers, which then spurs further investment. The 

health technology field is the perfect setting for this engine of invention and development. As health care technologies proliferate, patients, doctors, and researchers 

will realize the potential for the technology, and as a result, demand will increase. 

Increased demand means even greater incentive for investors to place their bets on 

the technology, which in turn spurs the cycle even further. 

In reading the testimony submitted by our witnesses in advance of today’s hearing, I was impressed by what can already be done in the healthcare field using the 

technology that exists, and what the potential is as we developed. In Mr. Misener’s 

written testimony, he describes how leveraging cloud technology allowed scientists 

to conduct an experiment at a cost that was orders of magnitude less than it would 

have been using traditional datacenters and infrastructure. This is exactly what we 

are hoping to learn more about today—how we can take advantage of what these 

companies are already experts at doing, be it technology or healthcare, and benefit 

everyone. 

I hope that our diverse panel of witnesses today will take this opportunity to expand on the specific ways in which their particular organizations are contributing 

to this space and what opportunities they see for the future. While there are undoubtedly obstacles that remain before some of these technologies come to bear, this 

conversation is a good starting point and a way to highlight why it’s worth working 

through the issues that arise. I would like to thank you all for being here today and 

I look forward to your testimony. 

Mr. WALDEN. And I now recognize Mr. Pallone for 3 minutes. 

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY 

Mr. PALLONE. Thank you. Thank you, Chairman Pitts and Chairman Walden. 

We are here today to discuss the ways in which promising new 

technologies may be harnessed by the healthcare industry to provide better quality care, inform healthcare research, and empower 

4 

Americans to better maintain their own health. The Subcommittee 

on Health has explored this issue in a number of different hearings 

this Congress, most recently in April, when we examined how 21st 

century technology can benefit patients. And what we have learned 

today and what I hope we will hear more about today is that these 

technologies may not just improve patient outcomes, but also have 

the potential to bring down the cost of care for everyday Americans 

and for the Nation. 

Many health systems are responding to the Affordable Care Act’s 

call to reduce costs and improve quality by adopting the use of 

technologies like electronic health records, health analytics, telemedicine and mobile health applications. By monitoring patient 

progress in real time, providers will limit costly readmissions and 

prevent the onset of advanced stages of disease. In fact, declining 

readmission rates played a significant role in slowing the growth 

of our Nation’s health spending in the years following passage of 

the ACA, and in the long-term budget outlook published Tuesday, 

the CBO found that the decline in our health spending will allow 

the Medicare trust fund to remain solvent for an additional 6 

years. 

And this testifies to how the law is pushing providers to improve 

the quality of care, but also to the potential of health technology 

like telemedicine and patient tracking systems to relieve the financial burden of preventable conditions on the entire healthcare system. 

In keeping with the ACA’s embrace of preventive care, many of 

these technologies will help keep people healthy and enable patients with chronic disease to better manage their conditions on 

their own. The CDC estimates that 133 million Americans live with 

at least one chronic illness disease like diabetes, heart disease and 

cancer, and the treatment of chronic illness accounts for more than 

75 percent of all health spending, so it should be clear that keeping 

Americans healthy must be a national priority. Additionally, with 

access to quality data, health researchers at the NIH and throughout the country will be better able to study the range of conditions 

which afflict Americans, research that can be used to develop more 

effective treatments and inform the practice of evidence-based medicine. 

Meanwhile, health analytics will allow insurers to design valuebased benefit plans which will reimburse providers for the quality 

and not the quantity of care they render. And with this monetary 

incentive, providers will more often invest in an ounce of prevention than wait to deliver a pound of care. 

Many of the technologies discussed today can improve Americans’ 

health, yet we must remember that the adoption of technology for 

its own sake does little good and can contribute to the escalating 

cost of medicine. We have to work to ensure that advances in 

health technologies serve to improve all Americans’ health, stopping the onset of preventable conditions while not exacerbating 

health disparities along socioeconomic lines. And further, we must 

make certain that the transfer of these data and doctor-patient 

communications complies with Federal regulations and that Federal law ensures the confidentiality of patient data. 

5 

Our witnesses today represent firms developing these technologies, and I thank them for their testimony as well as their efforts to improve Americans’ health. 

And Mr. Chairman, I am looking forward to hearing what is now 

in the field and how this further contributes to the past work of 

our committee. Thank you. 

Mr. WALDEN. Thank you, Mr. Pallone. Appreciate that. 

Now we go to the chairman of the Health Subcommittee, Mr. 

Pitts, for an opening statement. 

OPENING STATEMENT OF HON. JOSEPH R. PITTS, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH 

OF PENNSYLVANIA 

Mr. PITTS. Thank the chairman for this joint hearing of the Subcommittees on Communications and Technology and Health, and 

welcome all of our witnesses here this morning. 

As part of our committee’s 21st Century Cures Initiative, we are 

examining the discovery, development and delivery process to 

speed new treatments and cures to patients. One of the most promising avenues to facilitate this goal is new technology, and we are 

witnessing the impact of that technological innovation that it has 

played in every aspect of our economy. Technology has the potential to transform health care as well, and in doing so, address many 

of the challenges that we currently face. The question before us is, 

How do we ensure that our healthcare system can take advantage 

of the innovation going on in the tech world? 

We now have mobile medical apps that can make health care 

more personalized, if we don’t over regulate them. We have electronic health records that can be shared among various providers 

to help better coordinate the care we receive, if we can ensure they 

are interoperable. These and other technologies hold great potential for the future of health care and personalized medicine. In 

order to realize this potential, however, we are going to have to address barriers that currently make full integration difficult. 

Our witnesses are here today to help us think through these 

technologies and the role they can play in a 21st century 

healthcare system. So I thank all of the witnesses for being here 

today. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

As part of our committee’s 21st Century Cures Initiative, we are examining the 

discovery, development, and delivery process to speed new treatments and cures to 

patients. 

One of the most promising avenues to facilitate this goal is new technology. We 

are witnessing the impact that technological innovation has played in every aspect 

of our economy. 

Technology has the potential to transform health care as well, and in doing so address many of the challenges that we currently face. 

The question before us: How do we ensure that our health care system can take 

advantage of the innovation going on in the tech world? 

We now have mobile medical apps that can make health care more personalized 

if we don’t overregulate them. 

We have electronic health records that can be shared among various providers to 

help better coordinate the care we receive, if we can ensure they are interoperable. 

6 

These and other technologies hold great potential for the future of health care and 

personalized medicine. In order to realize this potential, however, we are going to 

have to address barriers that currently make full integration difficult. 

Our witnesses are here today to help us think through these technologies and the 

role they can play in a 21st century health care system. 

Mr. PITTS. And as I yield back, I ask for unanimous consent to 

submit for the record a letter from the Telecommunications Industry Association. 

Mr. WALDEN. Without objection, so ordered. 

[The letter follows:] 

7 

8 

9 

Mr. WALDEN. We now turn to the gentlelady, my friend from 

California, Ms. Eshoo, for opening comments. 

OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Ms. ESHOO. Thank you, Mr. Chairman. And welcome to the witnesses. And I want to thank the leaders of the two subcommittees 

for having this joint hearing. I think it is a terrific idea and an important one, to talk about the combination, the intersection of technology and medicine. And I think that in both areas, it represents 

American genius, and that is why I find it so exciting. 

My Silicon Valley District is the home of modern-day innovation. 

It really is the innovation capital of our country, of the world. It 

embodies an entrepreneurial spirit, and it attracts those who identify challenges and turn them into opportunities. They drive new 

technologies, expand education, and find creative ways to build a 

better world and to improve humankind. 

The valley has a long history of pioneering technological advancements. After World War II, the development of the semiconductor 

industry, which is really the foundation of Silicon Valley, led the 

way to the desktop computer and then to the explosion of the Internet, which continues to flourish. And I could tick off a whole list 

of honor roll names of companies that are identified with the Valley. 

What is equally important, in my view, in Silicon Valley, and it 

is not always widely recognized, are the parallel advancements in 

health care. My district is the birthplace of biotechnology in our 

country, and we have more biotechnology companies there than 

any other place in the country and in the world. So it is an eloquent statement about the region and what takes place. 

There are hundreds of young companies developing the latest 

therapeutics, medical devices, diagnostics, genomic tests and wireless healthcare technologies. And the ability for these two industries, high technology and health care, to mature side by side has 

really yielded, I think, unparalleled advancements for patients and 

dramatically improved healthcare outcomes. So that the whole 

issue of the power of broadband and wireless connectivity, it is the 

intersection of technology and health care, I think is more dynamic 

than ever. 

In Mountain View in my district, iHealth’s blood pressure monitor is empowering individuals to take charge of their health care 

by wirelessly connecting this data to a smart phone. That used to 

be for James Bond. Now it is for the average person. 

Similarly, Proteus, a Redwood City-based company is improving 

patient health care through an ingestible sensor which wirelessly 

sends information using blue tooth technology. I mean, this—it 

really is—it is not only cutting-edge, it is exciting and it is important. 

I am very proud to have Dr. Dan Riskin here today from my district testifying. Thank you for coming across the country to do so. 

He is a serial entrepreneur. He is the founder of Health Fidelity 

and consulting faculty at Stanford University School of Medicine. 

So thank you, Dr. Riskin. And he serves on the eHealth Initiative 

10 

Leadership Council and collaborated with the Bipartisan Policy 

Center on their oversight framework for assuring patient safety 

and health information technology. Jeez, I thought only in Government did we have long titles like this, but I guess it is in academia 

as well. 

So want to welcome all the distinguished witnesses here today. 

And, again, I thank the leadership of both of the subcommittees for 

putting this important hearing together. 

Mr. WALDEN. Thank you. 

Ms. ESHOO. And I yield back. 

Mr. WALDEN. Thank the gentlelady. 

We now turn to the chairman of the full committee, the gentleman from Michigan, Mr. Upton, for opening comments. 

OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF MICHIGAN 

Mr. UPTON. Well, thank you, Mr. Chairman. 

With this hearing, we are going to continue our commitment to 

modernizing laws and regulations to keep pace with the breakneck 

speed of the innovation era. Two leading initiatives have been our 

Comm Act update, which seeks to update the 80-year-old laws governing the communications and technology sectors, and obviously 

21st Century Cures, which aims to accelerate the pace of cures in 

treatments. 

Today we have the unique opportunity to bring together two of 

our subcommittees and look at the intersection of these efforts and 

the ways in which new technology is enabling remarkable advances 

in medical care and treatment and research. 

Our witnesses include established tech companies that are hoping to bring their expertise to bear on the challenges of modern 

health care as well as startups that are focused solely on tech solutions for patients and clinicians, from electronic health records, to 

cloud storage of genome research and apps that identify preventative health strategies, we are looking at the future of medicine. 

Technology is supporting proactive solutions, collaborative research, and improved communications between patients and their 

physicians. 

Our committee has gone great lengths to encourage investment 

in innovation in the U.S. Tech sector, and there are few applications of that work more important than the health of all Americans. We have the opportunity to not only enable new cures, but 

accelerate the pace at which they are realized. By taking full advantage of available technology, the possibilities for the future of 

health care indeed gives us hope. 

In June we held a round table to explore the opportunities and 

obstacles surrounding digital health care, and I look forward to 

continuing that conversation. It is my hope that this hearing, like 

the round table, will help us identify ways in which this committee 

and the Congress can support the adoption of lifesaving technologies in the healthcare sector. I thank you all for being here, 

and I yield back the balance of my time. 

[The prepared statement of Mr. Upton follows:] 

11 

PREPARED STATEMENT OF HON. FRED UPTON

With this hearing we continue our commitment to modernizing laws and regulations to keep pace with thebreakneck speed of the innovation era. Two leading initiatives have been our CommActUpdate, which seeks to update the 80-year-old laws 

governing the communications and technology sectors, and 21st Century Cures, 

which aims to accelerate the pace of cures and treatments. Today, we have the 

unique opportunity to bring together two of our subcommittees and look at the 

intersection of these efforts and the ways in which new technology is enabling remarkable advances in medical care and research. 

Our witnesses include established tech companies that are bringing their expertise to bear on the challenges of modern health care as well as startups that are 

focused solely on tech solutions for patients and clinicians. From electronic health 

records to cloud storage of genome research and apps that identify preventive health 

strategies, we are looking at the future of medicine. Technology is supporting 

proactive solutions, collaborative research, and improved communications between 

patients and their doctors. 

Our committee has gone great lengths to encourage investment and innovation in 

the U.S. technology sector, and there are few applications of that work more important than the health of all Americans. We have the opportunity to not only enable 

new cures, but accelerate the pace at which they are realized. By taking full advantage of available technology, the possibilities for the future of health care gives us 

hope. In June, we held a roundtable to explore the opportunities and obstacles surrounding digital health care, and I look forward to continuing that conversation 

today. It is my hope that this hearing, like the roundtable, will help us identify 

ways in which this committee and Congress can support the adoption of life-saving 

technologies in the health care sector. 

I thank the witnesses for being here with us today and sharing their experiences 

as health tech innovators. 

Mr. WALDEN. The gentleman yields back the balance of his time. 

The Chair now recognizes the distinguished gentleman and 

former chairman of the committee, Mr. Waxman, for 3 minutes. 

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA 

Mr. WAXMAN. Thank you very much, Mr. Chairman. 

This joint subcommittee hearing is a chance for members to 

learn more about the technological innovation taking place in our 

healthcare system. Technology can play an important role in expanding access to care, improving the quality of care, improving 

health outcomes, and reducing costs. 

In recent years, we have witnessed incredible innovation in our 

healthcare system, venture capital funding for digital health companies is at a record level, new innovators are entering the industry every day. And it is not a coincidence that all of this innovation 

has occurred in the years since we passed the Affordable Care Act. 

As a managing director of a major startup incubator put it, ‘‘We are 

seeing a lot of tailwinds from the healthcare reform. It has put a 

lot of pressure on existing stakeholders to reduce costs.’’ 

It is also not a coincidence that this innovation is occurring following our unprecedented investment in expanding the use of 

health information technology through the Recovery Act. The number of doctors using these technologies has quadrupled in just 3 

years. The percentage of hospitals using them has grown from 16 

percent to 94 percent. 

It is not a coincidence that we have seen all of this innovation 

with FDA and the FCC offering important guidance and using 

their enforcement discretion wisely. And it is not a coincidence that 

12 

we have seen this innovation at the same time that HHS has 

opened up vast amounts of data to the public while recognizing innovation with awards and grants to help startups shake up the 

health system. 

I mention these important ways the Federal Government has 

helped foster a climate of innovation, because this hearing and the 

committee’s 21st century cures initiative should focus on these successes. 

I look forward to hearing from today’s witnesses about what 

needs to be done to continue these trends that are improving our 

healthcare system every day. We should legislate only where appropriate and necessary, otherwise, we risk jeopardizing the integrity of a system that is already functioning quite well. 

Thank you, Mr. Chairman. I yield back the balance of my time. 

Mr. WALDEN. Thank the gentleman for his opening comments. 

And now we go directly to the witnesses. 

Thank you all again for submitting your testimony in advance. 

We appreciate that. And we will open up with Mr. Dave Vockell. 

Is that right? Did I say that correctly? 

Mr. VOCKELL. Close enough. 

Mr. WALDEN. And turn on that microphone. 

Chief executive officer of Lyfechannel. We are delighted to have 

you here. Please proceed. 

STATEMENTS OF DAVE VOCKELL, CHIEF EXECUTIVE OFFICER, LYFECHANNEL, INC.; DAN RISKIN, FOUNDER, HEALTH 

FIDELITY; PAUL MISENER, VICE PRESIDENT, GLOBAL PUBLIC POLICY, AMAZON; ROBERT JARRIN, SENIOR DIRECTOR, 

GOVERNMENT AFFAIRS, QUALCOMM INCORPORATED; AND 

JONATHAN M. NILOFF, VICE PRESIDENT AND CHIEF MEDICAL OFFICER, MCKESSON CONNECTED CARE & ANALYTICS 

STATEMENT OF DAVE VOCKELL 

Mr. VOCKELL. Good morning, Chairman Walden and Pitts. I am 

Dave Vockell, the CEO and founder of Lyfechannel, Inc. It is a 

great honor for me to be here today, and I want to thank you for 

the opportunity to testify on this very important topic of innovative 

technology and the current and potential impacts to population 

health. 

I would like to briefly cover three topics today: first, a short overview of Lyfechannel to give you some context as to the role that 

startups can play in the rapidly evolving healthcare delivery landscape; second. I will cover three lessons learned and the ‘‘so what’’ 

that might inform how you evaluate health technology opportunities; and third, I am going to share a list of large insiders who I 

think are forward thinkers and innovators in working with new 

technology, and to try to discover what is next for healthcare delivery. 

Lyfechannel, Inc., builds mobile patient programs that translate 

physician instruction into patient action, which help patients new 

to diabetes, pre-diabetes, COPD, heart health and smoking cessation begin to build basic good habits to support their chronic conditions. We also operate a preventive health program targeting the 

chief health officer of a household. We create programs that conVerDate Mar 15 2010 13:37 Aug 05, 2015 Jkt 037690 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113162X21CTECHJKTREQ073115\113162X21CTECHPENDING W
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nect the patient and their personal support team and their care 

providers through integration across mobile experiences and the 

provider’s electronic health record. 

Over the past 3 years, we have worked closely with patients, 

pharma companies, Government agencies, payers, EHR’s, providers 

and other technology companies to translate changes in technology 

and consumer behavior into opportunities to impact long-term 

health. We have learned three important lessons relevant to consumer facing health. First, if you are not integrated into the existing patient flow, whether it would be the physician or the provider 

or payer, it is almost impossible to become part of a patient’s 

health journey. Consumer health actions are not only the behaviors 

that new technology companies need to engage, but they are also 

hospital procedures, billing protocols, prescribing habits, hundreds 

of habits within the system that we need to be a part of. 

Number two, technology doesn’t change behavior, it just potentially creates a new access point to things that do change patient 

behavior. A cool app on your phone doesn’t make you take your 

meds by reminding you or making a game out of it. You don’t skip 

your Lipitor because it wasn’t fun or because you forgot; you skip 

it for the basic human behavior that you feel great and you are not 

connecting your current health behavior to long-term health. Technology experiences that reinforce the drivers of good health behavior create patient-led, not technology-led solutions. 

And finally, there remains a strong economic incentive not to release the data that will drive patient insights and recommendations for the next 10 years. Many payers do not release claims data 

that could fuel incredible insights into pinpointing health intervention opportunities, because they have a large business selling that 

data to pharma companies. Electronic health record companies 

don’t make it simple to exchange data with other EHR’s, because 

it reduces switching costs of moving to a different HR for a hospital. 

There are a handful of innovative large institutions that unleashed great innovative momentum through aggressive piloting 

and partnership with third parties, and the pattern of their innovation is similar. They make public a problem they are trying to 

solve, they make data available to support solving that problem, 

and then they find a pathway to engaging technology innovators to 

solve that problem. 

Here are a couple examples of those leading innovators. The Office of Disease Prevention and Health Promotion, under the guidance of Linda Harris, Ellen Langhans and Silje Lier of the ODPHP 

are pioneers in co-design of digital experiences incorporating health 

literacy principles. They not only engaged third-party technology 

companies against the goal of the ODPHP, but also systematically 

share their learnings with other Government and public sector 

groups to advance best practices and patient literacy around preventive health. Their Myfamily mobile program has been a pilot for 

the past 10 months and is about to release version 2, which includes EHR integration and connectivity with the new Apple 

Healthkit platform. 

Boehringer-Ingelheim, under the guidance of Jon Doniger in 

their new business model group, aggressively engages new techVerDate Mar 15 2010 13:37 Aug 05, 2015 Jkt 037690 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113162X21CTECHJKTREQ073115\113162X21CTECHPENDING W
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nology companies to help his organization understand the role that 

pharma could play in healthcare delivery in 10 years. 

The Allscripts EHR platform under the leadership of Tina Joros 

has also embraced third-party developers and platform openness to 

tap into the power of technology innovators. 

Johnson & Johnson, Robert J. Wood Hospital System, Box and 

CMS have also been aggressive in identifying problems, making 

data available to entrepreneurs and helping them try to solve their 

hardest problems. 

In summary, we believe that technology companies that partner 

with large insiders and lead with patient behavior versus cool technology have the greatest opportunity to impact health outcomes in 

the next 10 years. There are some great innovators that should 

serve as a model, and no shortage of technology innovators with 

limitless energy and caffeine to try to impact population health. 

Thank you again to the chairpersons and members of the subcommittee for your time today and the opportunity to participate 

in this hearing. I would love to answer any questions you have. 

Thank you. 

[The prepared statement of Mr. Vockell follows:] 

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Mr. WALDEN. Thank you very much, Mr. Vockell. We appreciate 

your testimony as well. 

And now we are going to go to Mr. Riskin. We appreciate your 

being here. And founder of Health Fidelity. Thank you for being 

here, Dan. And turn that microphone on, pull it close. And we look 

forward to your comments. 

STATEMENT OF DAN RISKIN 

Mr. RISKIN. Good morning, Chairman Walden, Chairman Pitts, 

Ranking Member Eshoo, Ranking Member Pallone and members of 

the subcommittees. It is an honor to testify. 

I am a serial entrepreneur, founder of Health Fidelity, a leading 

big data analytics company, and consulting faculty at Stanford University School of Medicine. In addition, I am a practicing physician, 

board certified in surgery, critical care, palliative care, and clinical 

informatics. I serve on eHealth Initiative Leadership Council and 

collaborated with Bipartisan Policy Center on their efforts toward 

patient safety and healthcare IT. 

I have been fortunate to succeed as an entrepreneur, educator 

and surgeon, and I am grateful to the Federal Government for contributing to my success. I have been awarded multiple grants from 

the NIH and National Science Foundation, each grant resulting in 

creation of multiple longstanding, long-term, high-paying skilled 

jobs. Every Federal dollar received has resulted in $15 of follow-on 

private sector investment. These efforts have led to companies and 

products used at Harvard, Stanford and other leading institutions 

to benefit patients and enhance medical knowledge. My background 

has afforded me unique insight into healthcare innovation and 

practice. 

21st century technology in health care includes devices, data, information-enabled work flow. This newly emerging data-driven 

health care not only offers the right information at the right time 

for the right patient, but also provides a needed pathway for population health, analytics and patient engagement. The goal is a more 

efficient, effective and approachable healthcare system. Collaboration and innovation are required, and Government has a critical 

role to play. 

Today I will focus on three actionable recommendations to promote safe and meaningful innovation in health care. These include 

re-defining interoperability to share the information that is needed 

for clinical analytics and population health; revising our approach 

to quality to better align with improved outcomes and reduced 

costs, and research to better understand safety and healthcare IT. 

I recently cared for a very nice woman who was failed by our 

healthcare system. A heart murmur had been noted during physical exam years earlier. Unfortunately, on changing her insurance, 

the information was buried and lost in medical documentation. Her 

failing heart valve was only discovered years later when she presented to the emergency department unable to breathe. She required an emergency operation, leading to an extended ICU stay 

and millions of dollars at taxpayer expense. If her condition had 

been recognized early and treated electively, the likely costs would 

have been far lower, and she and her family would have been 

22 

spared a month-long stay in the hospital. I will discuss recommendations in the context of her case. 

The first actionable recommendation is a better definition of 

interoperability. Current efforts and proposed regulations focus on 

sharing patient’s summaries only. Unfortunately, there is simply 

not enough information in these summaries for innovative analytics companies like mine to promote data-driven health care. In 

this clinical case, an exam finding was documented in the physician narrative, but did not show up on the problem list and would 

not be present in an interoperable summary. To support interoperability of summaries only, as is proposed in current regulation is 

to ignore critically important information such as home environment, medication compliance, exam findings and hospital course. 

Innovation and care improvement will be hobbled for years to come 

by this arbitrary limitation. 

Through the Meaningful Use program, our country has subsidized electronic capture of clinical data. Why wouldn’t we require 

that all data we paid to capture be available for use by innovative 

companies and technologies to actually improve care. 

The second actionable recommendation is an enhanced definition 

of quality. This patient’s care met all process measures required, 

she had routine tests, documented counseling, weight documented, 

but did she receive great care? Quality measures and increasingly 

selected for feasibility, meaning we often select for what is easy to 

measure rather than what really influences outcomes. In this case, 

a relevant measure of quality would be whether the patient received appropriate follow-up for her heart murmur. If quality measures are our national target, this is the time to refine our approach 

and require accurate and meaningful quality measures in health 

care. 

Finally, my patient’s information was exposed to many 

healthcare software systems. Were these systems safe and effective? While the country defines a first-pass approach to healthcare 

IT safety, we must acknowledge these IT systems are new, innovative and rapidly evolving. To refine our regulatory approach over 

time, we will need information on how and when healthcare software is safe versus potentially dangerous. Supportive academic and 

clinical research in healthcare IT benefits and risks would go a 

long way to help us refine regulation over time. 

We are going in the right direction. Health systems, payers and 

vendors are collaborating through new financing models and newly 

available data with new enthusiasm, but there is a great deal of 

work left to do if we are to bridge the gap from electronic information to better and more efficient care. 

I look forward to continuing to work with you to leverage our national HIT investment to create data-driven health care. The U.S. 

is well poised to revolutionize health care and to benefit our people 

and economy at home while showing global leadership in this critical industry. 

[The prepared statement of Mr. Riskin follows:] 

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Mr. WALDEN. Thank you very much, Mr. Riskin. We appreciate 

your testimony. 

We will go now to Mr. Misener, vice president, Global Public Policy at Amazon. Paul, please go ahead. Thanks for being here. 

STATEMENT OF PAUL MISENER 

Mr. MISENER. Thank you, Chairman. Good morning, Chairman 

Walden, Chairman Pitts, and Ranking Members Eshoo and 

Pallone. My name is Paul Misener, and I am the vice president of 

Global Public Policy at Amazon.com. On behalf of Amazon and our 

customers, thank you for inviting me to testify today on how 21st 

century technology enables 21st century cures. 

After briefly describing cloud computing technology, my testimony will illustrate how innovative healthcare organizations, both 

large and small, established and startup, public and private already use cloud computing to foster the innovation cycle of discovery, development and delivery of new biomedical treatments and 

cures. I will conclude by suggesting three ways that Congress could 

help accelerate this cycle by adopting policies to facilitate use of 

cloud computing for health care. 

With cloud computing, information technology users, including 

healthcare enterprises now can acquire technology resources such 

as compute power and storage on an as-needed basis instead of 

buying, owning and maintaining their own data centers and servers. 

In 2006, Amazon’s cloud computing business, Amazon Web Services, or AWS, began offering developer customers access to in-thecloud infrastructure services. AWS now has hundreds of thousands 

of customers, including over 3,000 academic institutions and 800 

Government agencies. 

In the healthcare sector, enterprises of all sizes and types are beginning to use cloud computing technology for the discovery of new 

biomedical treatment and cures. As the chairman mentioned earlier, in 2013, Novartis scientists discovered a large molecule involved in the disease mechanism for a particular type of cancer. 

The scientists wanted to virtually screen 10 million compounds 

against the large molecule. Such a large number of screenings is 

extremely computationally intensive. Novartis did not have the capacity in their existing data center to do this type of test, and 

building new infrastructure would have cost an estimated $40 million. Instead, using AWS, they built a virtual high performance 

computing center in the cloud and were able to perform the equivalent of 39 years of science in less than half a day and for under 

$5,000. 

Enterprises are also beginning to use cloud computing for the development of new biomedical treatments and cures. For example, 

in the summer of 2012, Merck was noticing higher than usual discard rates for certain vaccines. The high discard rates could result 

from many factors. Evaluating these factors for every vaccine produced was extremely challenging using a traditional spreadsheet 

approach, so instead, Merck worked with a partner to implement 

a cloud-based solution using AWS, and over a 3-month period, they 

were able to combine all of their data sources and perform over 15 

billion calculations and more than 5.5 million vaccine batch-toVerDate Mar 15 2010 13:37 Aug 05, 2015 Jkt 037690 PO 00000 Frm 00035 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113162X21CTECHJKTREQ073115\113162X21CTECHPENDING W
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batch comparisons, and thus they were able to precisely identify 

how characteristics of fermentation had direct impact on vaccine 

discard rates. 

Lastly, enterprises are beginning to use cloud computing for the 

delivery of new biomedical treatments and cures. For example, the 

USFDA, which receives 900,000 handwritten reports of adverse 

drug effects each year, needed a way to make the data entry process more efficient and reduce costs. Using AWS cloud computing, 

the FDA and Captricity quickly turned manual reports into machine readable information, reducing costs from $29 per page to 

$0.25 per page. 

Chairman Walden and Chairman Pitts, please allow me to suggest three ways that Congress could help accelerate the innovation 

cycle of discovery, development and delivery of new biomedical 

treatments and cures by facilitating the use of cloud computing for 

health care. First, to help accelerate the discovery of new biomedical treatments and cures, Congress could work with NIH to 

establish and operate cloud-based data management platforms to 

which federally funded researchers could upload their research 

data along with any relevant software resources required to reproduce their analysis of the data. Other researchers in the field could 

then access the data in software in order to reproduce the results, 

re-analyze previously collected data in novel ways, or even automate the analysis of new data using the same approach as the 

original experiment. 

Second, to accelerate the discovery and development of new biomedical treatments and cures, Congress could enact both H.R. 967 

and H.R. 1232. These are bills that would assess and facilitate the 

use of cloud computing by Federal science agencies. 

And third, to help accelerate the delivery of new biomedical 

treatments and cures, Congress could work with HHS to modernize 

implementation of HIPAA so that healthcare providers could readily employ the benefits of cloud computing. By narrowing the application of HIPAA to situations where cloud services providers have 

access to and knowledge of health information, time and money 

won’t be wasted on contracts that are mostly inapplicable, and 

cloud services providers can more reasonably comply with HIPAA 

by focusing on areas where they actually have access and knowledge of health information. 

Chairman Walden and Chairman Pitts, thank you again for holding today’s hearing and for inviting me to testify. I look forward to 

your questions. 

[The prepared statement of Mr. Misener follows:] 

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Mr. WALDEN. Those are wonderful recommendations. Thanks for 

your testimony. It is always impressive to see what is happening 

out there. 

For the members’ benefit, we have about 10 minutes to go in the 

first vote, but we always know that takes a little longer, so we will 

try and get through the witnesses if we can. 

We will go now to Mr. Robert Jarrin, Senior Director, Government Affairs, Qualcomm Incorporated. Thank you for being here. 

We look forward to your testimony. 

STATEMENT OF ROBERT JARRIN 

Mr. JARRIN. Thank you, Chairman. Good morning, Chairman 

Walden and Chairman Pitts, Ranking Members Eshoo and Pallone, 

and members of the subcommittees. On behalf of Qualcomm, an 

American company and the world’s largest wireless chipset supplier and largest licensor of mobile technology, it is an honor to be 

here again. Thank you for inviting me. 

Mobile technology, Qualcomm’s specialty, has become the largest 

communications platform in the history of the world, and it continues to grow. Currently, there are 355 million connections in the 

U.S. and over 7 billion globally. 

We forget how quickly mobile technology has proliferated. The 

Android OS and Apple’s iPhone were launched in 2007, the iPad 

in 2010. You wouldn’t know it, the way consumers rely upon these 

services and devices. Qualcomm can’t make this happen by itself, 

which is why we work with many partners. I am pleased to be here 

today with one of them, Amazon.com. Their leading-edge Kindle 

Fire HDX tablet, Fire smartphone and Fire TV media player all incorporate Qualcomm’s innovative Snapdragon chipsets. 

Qualcomm’s technologies are found in products that touch every 

aspect of society, including health care, which is why in 2011, we 

launched Qualcomm Life, a wholly owned subsidiary focused on 

medical device connectivity and management of health data. At 

Qualcomm, we understand that nothing can transform a sector like 

mobile 3G and 4G technologies. Health care is a good example, one 

in which I have personal experience. 

On August 16th, 2006, my mother was diagnosed with Stage III– 

C late term ovarian cancer. She was 65, a widow, with limited 

English proficiency. From the start of her odyssey, I discovered 

that doctors, clinics and hospitals were not sharing her healthcare 

information. I was struck by the lack of continuity of care. When 

she left the care provider or facility, there was no mechanism to 

remotely monitor her basic physiological status. This seemed dangerous in light of countless doses of chemotherapy, protein inhibitors, and toxic serums she endured, which caused horrible side-effects, including extreme high blood pressure and edema. 

In the years since my mom’s initial diagnosis, mobile computing 

devices have helped personalize health care. Remote patient monitoring is now helping drive systemic changes in healthcare networks. Platforms, such as Qualcomm Life’s HealthyCircles, facilitate the management and sharing of medical information between 

stakeholders across the patient’s healthcare community. 

Qualcomm Life and its partners produce novel commercially 

available 21st century mobile medical solutions, such as mobile 

41 

ECG recorders, wireless telemetry sensors, mobile glucose monitors, software systems that deliver live patient data to a doctor’s 

smartphone, smart inhalers, and radiological imaging viewers for 

mobile devices, and implantable pulmonary sensors that communicate wirelessly with bedside monitors. 

The future is even more exciting. The X PRIZE Foundation and 

Qualcomm developed a $10 million competition, the Qualcomm 

Tricorder X PRIZE, to produce a device that diagnose 15 distinct 

diseases in a group of 15 to 30 people within 3 days by a consumer, 

independently of a healthcare worker or facility. 

If investments are any sign of the future, the first half of this 

year shows 143 companies having raised $2.3 billion year to date, 

thus eclipsing the 2013 total of $2 billion. Those investments include some by the Qualcomm Life Fund, which was formed in 2011 

and is now considered one of the most prolific investors in wireless 

health. 

However, challenges do persist. Lack of reimbursement is a 

major barrier to telehealth and remote patient monitoring technologies. Medicare telehealth provisions in the Social Security Act 

are overly restrictive and exclude the majority of these technological innovations, and that needs to be changed. Another is the 

Center for Medicare and Medicaid Services EHR incentive payment 

program, popularly referred to Meaningful Use rules, which do not 

include the ability to upload patient-generated health data into certified EHRs. Future stages of the program should specify the incorporation of patient-generated health data from home use medical 

devices into EHRs. 

Another important issue is spectrum, the lifeblood of our wireless 

networks. Qualcomm commends this committee and Congress for 

all the work it is doing to make additional mobile broadband spectrum available. This work is critically important. 

In closing, the speed of innovation should never come at the expense of patient safety. Health IT software and mobile medical 

apps developers should support data collection and quality mechanisms to foster patient safety and create a learning environment. 

Nearly 8 years after my mom’s diagnosis, I am thankful to her 

healthcare team that she is continuing to live an enjoyable life. I 

am also grateful for the advancements in 21st century medical 

technologies are helping society as a whole. Qualcomm has played 

a significant role in mobilizing health care, to improve lives and advance digital medicine, and it will continue to do so. 

Thank you. I look forward to your questions. 

[The prepared statement of Mr. Jarrin follows:] 

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Mr. WALDEN. Mr. Jarrin, thank you. And that is good news on 

your mother. Having lost a mother to ovarian cancer, I know how 

awful that—— 

Mr. JARRIN. I am sorry to hear that. 

Mr. WALDEN [continuing]. Diagnosis is and the treatments can 

be. So I am glad to hear your mother is doing well. 

We will now go to Dr. Jonathan Niloff, Chief Medical Officer and 

Vice President, McKesson Connected Care & Analytics, McKesson 

Corporation. 

And for our members, the Whip’s office will keep the vote open 

until we get there, so we can conclude with our final witness this 

morning. 

So Mr. Niloff, thank you. 

STATEMENT OF JONATHAN M. NILOFF 

Mr. NILOFF. Thank you. Good morning, Chairman Walden and 

Pitts, Ranking Members Pallone and Eshoo, and distinguished 

members of the subcommittees. I appreciate the opportunity to appear before you today. 

Throughout my career as a gynecologic oncologist in Boston, faculty member at Harvard Medical School, and founder of a small 

health IT company, I have seen firsthand the power of IT to improve outcomes, reduce costs, and accelerate the pace of change in 

our healthcare system. 

As the largest health IT company in the world, McKesson is focused on the transformation of health care from a system burdened 

by paper to one empowered by interoperable electronic solutions. 

There is a significant opportunity to improve our healthcare system, but to do so, we must fundamentally transform how care is 

delivered. We need to move from a fragmented model of care, 

where each patient visit is disconnected, to a model where care is 

coordinated across the entire continuum. Interoperable health IT is 

foundational to this transformation. 

I would like to share today two recommendations which will advance health care in the 21st century. First, we must align payment and coordinated care models in order to create an environment that fosters interoperability; and second, we need a new riskbased regulatory framework that is specific to health IT. 

We don’t today have an easy, uniform way to move patient data 

between care settings. The interoperability we need requires collaboration among all stakeholders to develop uniform standards, 

coordinated policies, and the necessary infrastructure to promote 

interoperability and assure coordination of care. 

ONC has provided an important role in providing common guardrails for the exchange of health information. It is important that 

we maintain flexibility within those guardrails to allow for industry 

innovation. One example of innovation and interoperability is the 

CommonWell Health Alliance. CommonWell was founded by 

McKesson in partnership with our competitors to develop a software solution that will share patients’ data, with their consent, 

across multiple settings of care. We have made significant progress 

in endeavor over the last 18 months. It is essential that we are 

able to share the right patient data in the right place and the right 

57 

time. This solution is imperative to creating a new model of coordinating care. 

Fostering innovation in the private sector is critical, but there is 

also a role for Congress to play. Policy changes are needed to reflect current advances in technology and promote ongoing innovation. A 21st century health system demands 21st century policies. 

We support a new regulatory framework that would establish three 

categories of health IT. Oversight of each category would vary according to potential risk to patients and the role of the clinician. 

The FDA should continue its important role in regulating software with the highest potential risk; however, we believe Congress 

should amend the Food, Drug and Cosmetic Act to define each of 

these categories of health IT and provide clarity that clinical and 

administrative software should not be regulated as medical devices. 

To realize a true 21st century healthcare system, we need fundamental change in our healthcare delivery model. We need to replace our fragmented system with patient-centric coordinated care. 

This transformation has begun, but we need to accelerate the pace 

of change, and to do this, we must harness the power of technology. 

Specifically, we must align reimbursement and payment models to 

promote the adoption and also the interoperability of health IT, 

and Congress must update the law to codify how health IT is regulated in a way that, while assuring patient safety, is predictable 

and fosters innovation. The result will be better outcomes, better 

access, better cost efficiency, and better experiences for patients 

and their families. 

Thank you for the opportunity to testify today. 

[The prepared statement of Mr. Niloff follows:] 

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Mr. WALDEN. Dr. Niloff, thank you for your testimony. Thanks 

to all our witnesses. 

We will go vote and then members will come back and ask questions. We are probably going to be gone at least a half an hour, I 

would assume, so if you need to take a break, it is a good time. 

We will reconvene immediately after votes. Thank you very much. 

We stand in recess. 

[Recess.] 

Mr. WALDEN. I will call the subcommittee back to order and appreciate again the testimony of our extraordinarily distinguished 

panel of witnesses. Thank you very much. 

And don’t think you are off the hook because I think what you 

have given us here is very important, and we will be following up, 

I am sure, over the months and years ahead to dive deeper with 

you on how we can all get this right. 

I am going to start off with questions, and the first one goes to 

Mr. Misener. Are there any laws or regulations that have impacted 

the development of the cloud that we should take a look at deeply, 

change that hinder what we are trying to accomplish here, what 

you are trying to accomplish here? 

And obviously we have got to protect data and privacy and security and all that, but are there other things we should be aware 

of that would facilitate advancements in the sectors we are talking 

about today? 

Mr. MISENER. First of all, thank you for the question, Mr. Chairman. There are areas in which Government could lead, provide an 

example to private industry, and one particular roadblock we have 

run up against over the years trying to serve Government institutions including the U.S. Federal Government and its agencies, is 

that there is oftentimes money set aside for agencies to buy computers, to buy software, to invest capital essentially which is highly 

inefficient when instead money could be allocated for purchasing 

service, making it an operational cost rather than a capital investment. 

And the Government could not only be able to be much more 

flexible that way, in other words, only purchase what is needed and 

then discard it if it is not needed, but also it allows Government 

to scale up and scale down as necessary. But we have also often 

run into problems where agencies are only given authority to buy 

specific things like hardware or software when actually they should 

be able to have the freedom to obtain services instead. 

Mr. WALDEN. Got it. So on another issue, and back to you, Mr. 

Misener, and if others want to weigh in on these subjects, please 

feel free to do so. But, how can we modernize HIPAA to ensure 

that patient information is protected but that we can still utilize 

data? There are other countries that have laws that protect patients but also facilitate data sharing and leveraging the research 

being done. 

I know in our round table that Chairman Upton convened recently, Dr. Brian Druker who heads the Knight Cancer Research 

Center in Oregon, talked about I think it is 65 petabytes—did I say 

that right?—of data, just involving cancer patients that could be 

harnessed to do an analytic work and all and research. Are there 

67 

some issues with HIPAA; are there things we should be looking at 

in that respect? 

Mr. MISENER. There are, Mr. Chairman. It is not a huge barrier 

at this point, but what we would like to be able do is recognize that 

there are sometimes when information is stored in the cloud where 

it is known to be health information and it is accessible to the 

cloud service provider. But most of the time that is not the case. 

We don’t know what information is stored there, and it is also 

encrypted, so we can’t get at it; and yet we still have to go through 

HIPAA hoops as if we had access to the information. 

Mr. WALDEN. So what would that mean in real laymen’s terms? 

Mr. MISENER. It means the health care enterprise that is storing 

data on our servers, has HIPAA requirements placed upon it, but 

those requirements are also placed on a cloud services provider, 

even though it is entirely unnecessary. We can’t see that data, and 

usually we don’t even know it is there. 

Mr. WALDEN. But from a practical standpoint, what does that 

mean in your company you have to do? 

Mr. MISENER. I think it means asking NIH not to interpret the 

rules so broadly as to require a cloud services provider to comply 

with HIPAA where it is not necessary. But of course we do comply 

with HIPAA, Amazon Web Services does, when it is necessary. 

Mr. WALDEN. OK. 

Dr. Niloff, what are the technical challenges your company is facing as you work to innovate in health care that we might need to 

take a look at, besides what you outlined in your testimony? 

Mr. NILOFF. Sure. So, I think the major technical challenges involve interoperability, and the typical environment in the health 

care system is very heterogeneous with multiple different EMRs 

and multiple different other systems that we need to connect to. 

Mr. WALDEN. EMRs being electronic medical records? 

Mr. NILOFF. That is correct, sir. And solving that challenge, the 

technical challenge of connecting such heterogeneous environments, 

is a big barrier today. 

Mr. WALDEN. All right, anybody else want to weigh in on these 

topics. 

Mr. VOCKELL. I would say the HIPAA question initially, the inability of patients to give up their right to privacy, like the HIPAA 

requirements are kind of universal whether it is I have a cold or 

whether I have HIV. And there are some conditions where let’s say 

I had celiac disease, I would love to tell everyone on earth that I 

have it because most likely that is how I am going to find out better ways to take care of myself. But because of HIPAA, I can’t even 

email my doctor. 

And so I think if there were additionalopportunities, let’s make 

it super simple. I want to email my doctor; he wants to email me 

back, but we don’t because it is against HIPAA for him to send me 

health information, but both of us would agree that it is OK for me 

to talk about my kid’s fever through email. So I think what that 

kind of example we have around regulation is that when the FDA 

kind of took their very vague some mobile stuff might be good, 

some mobile stuff might not be good and made it we are all hanging around. 

68 

And they said, all right, you guys can leave the room; you guys 

come in, we want to talk some more, and you guys stay close, that 

changing very gray to more black and white allowed a lot of people 

to innovate and build something and do stuff. 

Mr. WALDEN. Yes. We did an oversight hearing on that very 

issue about a year ago because nobody was getting clarity whether 

your iPad was a medical device or not, and we got them to admit 

some of those things. 

Mr. VOCKELL. I would have stood up and applauded. But I think 

similarly with HIPAA, if there could be another layer of, this is 

what is covered, and this is what isn’t; it is OK to email your doctor about your kid’s flu, that would do a lot to create innovation 

points for better care. 

Mr. WALDEN. All right. Thank you. 

I have overextended my time. I will now turn to the gentleman 

from New Jersey, the ranking member on the Health Subcommittee, Mr. Pallone, for 5 minutes. 

Mr. PALLONE. Thank you. 

Reading the testimony today, I was impressed by how much 

progress we are making towards a more technologically advanced 

health care system, and one important step the Federal Government is taking to encourage this innovation is to open up much of 

the data it collects to the public. That allows developers, programmers, and academics to dig into this data and develop new tools to 

help improve our system. 

I wanted to ask Mr. Vockell, can you talk more about how you 

have put this open data to use and the potential benefits of this 

increased transparency over the long-term? 

Mr. VOCKELL. Yes, thank you very much. Lyfechannel—about six 

months ago, CMS released the big data set around exactly what 

every provider for Medicare charges for every protocol. And a couple weeks ago at the Health Datapalooza, which is a lovely name 

that I think Todd Park came up with, that Government and public 

agencies come together to talk about the incredibly exciting topic 

of health data. They had a competition to say for this big data set, 

who can make it into something super interesting. 

And Lyfechannel 1, largely based on some research that we did 

at the International House of Pancakes, the good example that 

CMS sets is they release data before it is totally perfect. The CMS 

data was 50 percent actionable. But we said early and they give 

entrepreneurs or any great data analytics house a chance to churn 

through it and pull out what they can and then make recommendations on what the next version of the data should look like. 

I think the more that holders of that health data are encouraged 

to kind of release it when it is excellent, not when it is perfect, will 

allow entrepreneurs to get up on it like a shark and reveal if there 

is something inside or help identify what the next round of it 

should look like. 

Mr. PALLONE. Thank you. I think the steps that CMS and the 

other Federal agencies have taken in this area are really important. I wanted to ask Dr. Riskin, in your testimony you state that 

health quality measures are often selected because they are easy 

to track. Could you elaborate on your recommendation that we 

69 

need more accurate and meaningful quality measures in health 

care? 

Mr. RISKIN. Yes. Thank you for your question, Mr. Pallone. 

The challenge is whether we try to develop measures for what is 

easy to do today or whether we create a target for what we need 

to do to improve health care. If we create a target for what we need 

to do to improve health care, we won’t be able to hit it today. The 

technology doesn’t exist. If we don’t, if we pick what is easy, then 

we won’t actually meaningfully reduce costs in health care in a 

short term. 

So to give an example, an easy quality measure would be, are 

you counseling people for smoking cessation, and a hospital might 

meet that measure by on every discharge summary writing, you 

should not smoke. That doesn’t do a lot of good if it is buried five 

pages down and mostly put in for non-smokers anyway. 

On the other hand if the measure is, do you smoke and that ties 

to an outcome like reduced costs and improved quality of care, that 

is the kind of measure that is meaningful. We don’t do a lot of that 

because it is so hard to measure, but over time the really robust 

analytics companies will figure out a way to hit that target if the 

Government makes that known that that is the target to hit. 

Mr. PALLONE. Thanks. And, Mr. Jarrin, in September last year, 

FDA issued a final guidance on mobile medical applications. It provides a long list of applications that FDA does not intend to regulate at all. Basically I just wanted to get your views on this guidance. I mean, do you think that the FDA struck a proper balance 

between protecting patients safety on the one hand and allowing 

innovation to flourish on the other? And do you see any risks in 

trying to legislate in this area? 

Mr. JARRIN. I think FDA did a good job by issuing the final guidance on mobile medical applications. It was definitely very different 

from the original draft. The original draft basically just restated 

the law without any clarity and without any vivid example. 

In the final draft guidance, they provided numerous examples of 

what they were putting under enforcement discretion, enforcement 

discretion being the ability for the agency to state publicly we are 

not going to obligate regulatory requirements on certain medical 

devices. Even though by definition they are medical devices, we are 

not going to require regulatory obligations. So I think that was 

very helpful to the industry. 

Mr. PALLONE. What about the risk though in trying to legislate 

in this area? 

Mr. JARRIN. I am not sure I would say that there is a risk in legislating the area. I think that that was the next evolution to what 

Congress had originally intended through FDAISA. Through 

FDAISA they had asked for a risk-based regulatory framework. 

The agencies then came out with that through the FDAISA draft 

report that they are contemplating currently. I think it is now the 

next step for Congress to decide whether it would like to go in and 

make those recommendations, you know, codify them. That is a 

higher pay grade than me. 

Mr. PALLONE. Thank you. 

Thank you, Mr. Chairman. 

Mr. PITTS. [presiding]. The Chair thanks the gentleman. 

70 

I will recognize myself 5 minutes for questions. 

Mr. Misener, in your testimony you suggest that Congress work 

with NIH to establish and support the cloud-based management 

platforms. Can you expound a little bit more on why you think this 

is so important? What are some of the benefits cloud-based platforms might lend to 21st century cures? 

Mr. MISENER. Thank you, Chairman Pitts. 

Modern biomedical research is a highly collaborative process. All 

scientific research these days is collaborative. The days of a major 

breakthrough coming from a sole, an individual working with a 

Bunsen burner and a test tube, it is over. You only need to look 

at some of the scientific journals and see the lists of authors. It is 

no longer unusual to see hundreds of authors listed in a major scientific paper, even over a thousand. 

And so that kind of co-research requires collaboration. And if the 

Federal Government can establish a way for federally funded researchers to share their information, even outside their normal 

channels of collaboration, it will become far more efficient and 

more productive. 

Mr. PITTS. And you mentioned one other concrete step that you 

recommended as we decide, if we decide to support this endeavor. 

List some other concrete steps that Congress can take. One was 

clarifying HIPAA. What are others? 

Mr. MISENER. Well, there are two bills that the House has already addressed—and hopefully they will be addressed in the Senate, as well—that actually would assess the Government’s provision or accommodation of cloud computing for scientific agencies, 

and another would clarify Government agency’s ability to obtain 

cloud services in lieu of hardware and software. Both of those are 

important pieces of legislation, not only on their own merits or on 

their own rights of what is going on within the U.S. Federal Government, but as setting an example to State and local Governments, to private industry, to Governments in other countries, that 

there is a great deal of efficiency that can be gleaned from the 

cloud in dealing with collaboration that I mentioned and also just 

the massive amounts of data that now go into any form of scientific 

research, including biomedical research. 

So Government setting an example, I think, is something that 

Congress can be part of right now. 

Mr. PITTS. You mentioned Amazon worked with FDA to turn 

900,000 handwritten reports of adverse drug effects each year into 

machine-readable information with 99.7 percent accuracy, reducing 

the cost from $29 per page to 25 cents per page. This Cures Initiative is in part focused on using technology to relieve administrative 

burdens for agencies such as FDA, so they can use the resources 

to invest in more researchers and new development methods such 

as biomarkers. Do you have other suggestions for other ways we 

can increase efficiency at FDA or other agencies? 

Mr. MISENER. Yes, Mr. Chairman. There is a model of scientists 

doing things that they don’t need to be doing. 

One would be for example, I don’t know, producing their own 

electricity for their laboratories. You don’t want them out in the 

back of the laboratory working on a diesel generator just so their 

labs have lights. Likewise, you don’t want them to have to be tinVerDate Mar 15 2010 13:37 Aug 05, 2015 Jkt 037690 PO 00000 Frm 00076 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113162X21CTECHJKTREQ073115\113162X21CTECHPENDING W
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kering with computing equipment, either for storage or for computation, in a way that that could easily be provided like a utility, 

like electricity. So let’s figure out ways to allow our scientists to be 

scientists, our doctors to be doctors, and not have to have them be 

information technologists at the same time, even though as part of 

the collaboration and the data-intensive work that they are doing, 

computation is absolutely necessary. It is just that they don’t need 

to be the ones doing it. 

Mr. PITTS. Now, we talked a little bit about HIPAA. Are there 

other countries that have laws that protect patients but also facilitate data sharing, leveraging the research being done? Any of you 

who would like to—— 

Mr. VOCKELL. Yes, I am not familiar with other countries’ details. 

Mr. PITTS. Anyone familiar with other models? 

All right, let me just go finally—one common recommendation 

was for fully harnessing the potential of interoperable technology. 

Are we talking about just electronic health records, or do you think 

that medical devices, other health care sources of data should be 

interoperable, if you will elaborate on that any of you? 

Dr. Niloff? 

Mr. NILOFF. Yes. Thank you. I think that the interoperability has 

to extend beyond just electronic health records. There are multiple 

sources of both clinical and non-clinical data that are important to 

aggregate together with the clinical data in electronic health 

records, and that interoperability should exist. 

There are also a variety of an analytic solutions which are important to improving population health. So solutions that identify patients that are likely to be hospitalized, patients who have progressing illnesses, and the ability to link clinical and claims data 

with those type of systems to allow the early proactive intervention 

in the care of those patients, is a very valuable intervention to 

driving improved health, decreasing hospitalizations, and decreasing emergency room visits. 

Mr. PITTS. Chair thanks the gentleman. 

Now recognize the gentlelady from California, Ms. Eshoo, 5 minutes for questions. 

Ms. ESHOO. Thank you, Mr. Chairman. 

I want to say to each of you, ‘‘Bravo.’’ I think every single one 

of you have been terrific witnesses, and you have given us—which 

is so important in a hearing, instead of starting with Adam and 

Eve, you have gone right into the meat of the subject matter to 

make recommendations for us, and that really is so helpful. So 

thank you to you. 

On this issue of interoperability, obviously there is more than 

one part of it, and what I wanted to ask you, Dr. Niloff is, is there 

anything that the Government is doing today that stands in the 

way of interoperability, as you just described it; i.e., in patient’s 

record, is a physician prohibited from putting in the last line these 

are the most important things to track with this patient? I am not 

a doctor, so I am probably not stating it, you know, as beautifully 

as I should. 

But I am trying to figure out where we have regulations that 

need to be written, where we have regulations that don’t make any 

72 

sense anymore, or what we need to write and put on the books, and 

all of these areas are really important. So can you answer my question? 

Mr. NILOFF. Sure. Thank you. So, electronic medical records typically have a lot of flexibility but we are—— 

Ms. ESHOO. Thank you. I helped write the legislation on it, so it 

is nice to hear. 

Mr. NILOFF. But, you know, I think that with electronic health 

records and the rest of healthcare technology, we are at the beginning of a journey, and it is a journey that is going to take us many 

years to get to both to the level of sophistication in the solutions 

and in the level—— 

Ms. ESHOO. But specifically, though, when it comes to interoperability and electronic health records, are there regulations that you 

think don’t make sense, or are you calling for something that will 

help advance interoperability? We deal with interoperability all the 

time at communications and technology relative to the telecommunications industry. This is a different deal. That is why I am 

probing here. 

Mr. NILOFF. Sure. I think that the thing that will drive interoperability the most and where the Government can have the 

greatest influence, is in making the business case for interoperability for those who are going to pay for it and what that means 

is that we need to align the payment models. 

Ms. ESHOO. I think that for the most part now is private sector 

though, because there were initial grants or whatever to get the 

electronic records going. I think that money has been spent. So I 

don’t think we are players in it. 

Mr. NILOFF. If I may, I am not talking about direct incentives. 

What I am referring to is that—— 

Ms. ESHOO. We need to speed it up. I have 1 minute and 20 seconds left. You have had 4 of my minutes almost. 

Mr. NILOFF. OK. I apologize. 

Ms. ESHOO. That is all right. Go ahead. 

Mr. NILOFF. How we pay for medicine and what I mean by that 

is if we are doing global payments, if we incent the delivery model 

to do a coordinated care model and the payment is aligned with the 

delivery model—— 

Ms. ESHOO. I understand that part of it. 

Mr. NILOFF. We will drive the adoption of this type of technology. 

Ms. ESHOO. Well, thank you very much. 

To Dr. Riskin, I see you nodding, and I think you want to say 

something. 

Mr. RISKIN. So to the same question, there are choices that are 

being made right now that could be better. So the choice for interoperability right now is we only share information out of the electronic health record that is perfectly structured, meaning only information—— 

Ms. ESHOO. So how do we make this more robust and meaningful 

so that the right information is extracted because that feeds 

through the whole system? 

Mr. RISKIN. Sure. So if a doctor wrote right now what is really 

important here is these three things, that would be ignored and 

never shared. What is needed is—— 

73 

Ms. ESHOO. But the Federal Government shouldn’t be instructing 

doctors how to write something. 

Mr. RISKIN. It doesn’t matter how—the doctors will write what 

they write, but the Federal Government is instructing what needs 

to be shared in interoperability format. 

Ms. ESHOO. So share is the operative word? 

Mr. RISKIN. That is right. And if we share all of the information, 

then the analytics companies can pick up the useful information. 

Ms. ESHOO. I just have so many questions, but my time has run 

out. I think what I will do is to submit questions to you both about 

the cloud, software, hardware; that is another whole thing. I am so 

thrilled that your mother, that you told a beautiful story, and it 

means a lot, I think, to all of us. Certainly to you. 

Thank you, Mr. Chairman. 

Mr. PITTS. The Chair thanks the gentlelady. 

Now recognize the gentleman from Illinois, Mr. Shimkus, for 5 

minutes of questions. 

Mr. SHIMKUS. Thank you, Mr. Chairman. It is great to have you 

all here, and I am going to try to be quick, too. 

But I am going to just segue right after my colleague Congresswoman Eshoo’s question, is getting out of order the way I wanted 

to go. 

But, Mr. Riskin, this data information is really the crux, and so 

I am concerned that, or the question is, if you are going into the 

genomics debate and personalized medicine, the data, are we in the 

way because of HIPAA or some other rules and regs that we are 

afraid to put the data available to a larger field because of the 

rules and regs we have in place? 

Mr. RISKIN. Yes. Thank you for the question. Yes, certainly the 

privacy and security policies make it tougher to share data. With 

that said, I am one of the biggest proponents of keeping data safe. 

We are asked as a big data company to use genomic data and combine that with phenotypic data, the clinical information, and figure 

out what it means. Keeping it safe is critically important. That 

doesn’t mean that you shouldn’t share it safely. So if the private 

sector can keep it safe and follow regulations to do that but there 

is also a requirement that the information come out in certain formats so it can actually be used, that is a very powerful setup, so 

all of the data we have paid to collect can be used to do meaningful 

things. 

Mr. SHIMKUS. So let me move to Mr. Misener on kind of the 

same talk. A lot of folks are afraid to go into this field because they 

have done a business analysis. They don’t know if there is a return 

on investment. You guys have decided to try and move in this, and 

so data storage and computation is the area that you think obviously can get you a business model plus improve. 

You know, I am a market capitalist, so we don’t get these investments unless there is a return on investment. We don’t get that 

unless there is improved health access and the like. So is that the 

model, the business model that you think that you all can do is this 

big data storage and computation while keeping that data safe and 

secure. 

Mr. MISENER. Yes, Mr. Shimkus. We very much believe in this 

business. We are very passionate about it as well. We kind of 

74 

backed into it as a retail company online. We figured out at one 

point that, gee, we have a business in keeping data safe and organizing it and storing it and being very efficient about it. So we 

started making it just kind of a service available to developer customers. We think in the medical field, the medical sector, there are 

many opportunities for the storage and sharing of data in a way 

that is highly secure. 

We not only believe that security is incredibly important to our 

business, but it is actually much easier to do at scale. We have the 

ability to provide security measures in the cloud that just aren’t 

available for local storage of information and so we are passionate 

about it, and I think we are an enabler of the genius that you see 

at the table here. 

Mr. SHIMKUS. Just because I want to get the last two in. In the 

mid 1970’s, Congress defined medical devices, which I think for the 

most part people thought at that time was good and helpful. The 

question is, is it time for us to look at codifying terminologies to 

help us through these processes? I mean a lot of us talk about FDA 

and how do we expedite, but don’t you think it might be time to 

look at some new words and definitions and define them in the law 

so that we can get some application speedily and I just kind of 

throw that up as a comment. Anyone want to jump in real quick? 

I got one more question so if you can be brief. 

Dr. Niloff? 

Mr. NILOFF. Yes, so I believe that, that is very important. You 

know, when I went to medical school, we didn’t have computers. 

This is all new stuff, and that is the era the law was developed, 

and I think that we need sort of new law that conforms with the 

state of the world as it exists today. I think that is really essential 

to driving investment. 

Mr. SHIMKUS. Let me follow up because your testimony, you really talk about developing a new risk-based regulatory framework 

that is specific to health information technology. With my remaining time do you want to talk about that a little bit? 

Mr. NILOFF. Sure. So you know, I think it is essential. I go back 

to you know, when I started my company. I raised four rounds of 

venture capital, and the process was very similar every time. Once 

you figured out the business model with the investors, they wanted 

to know two things. What’s the IP issues or the patent problems, 

and what is the regulatory environment and how is that going to 

affect their investment and the risk of their investment, and it happened every time. 

And also predictability, a stable environment where everything is 

codified and predictable is critical, and it has to be over the longterm. I thought one round was going to do it, and I was all set, 

but we ended up with four rounds. And it is a long process, you 

need a stable environment for it to drive technology and innovation. 

Mr. SHIMKUS. Thank you. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognize the gentleman from Texas, Mr. Green. Five minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman. Again, thank you for calling the hearing on joint telecomm and health care. 

75 

In a July 4th article in Forbes the co-founders of Google were 

asked if they would imagine Google becoming a health company. 

Their response was no. To quote Mr. Page, ‘‘generally health is so 

heavily regulated, it is a painful business to be in. Even though we 

do have some health projects, we will be doing that in a certain extent, but I think the regulatory burden of the U.S. is so high I 

think it would dissuade a lot of entrepreneurs. In my experience 

this is not an isolated sentiment from the tech community.’’ 

Doctor, now in your experience, is Google’s view of innovation in 

the health care sector a common one? 

Mr. NILOFF. Yes, sir. You know, I think as I have had you know, 

sort of lots of opportunities over the years when I was running my 

company to meet with other entrepreneurs and largely through forums through our investors, and this was a common topic of discussion. You know, overregulation is an inhibition to investment and 

an inhibition to innovation. 

So having, as I just stated, a stable environment that is predictable and where we are not prohibiting investment and therefore innovation is important and I believe widespread. 

Mr. GREEN. Well, just from what some of us know, and this is 

such a good coordination of these two subcommittees because of 

what we can do with the combination of the high tech and the 

health care, it literally could open up so many avenues for folks. 

I know there are some supporters of the current regulatory approach of health care that suggest that the regulatory uncertainty 

under the FDA is a proper approach, which I don’t obviously agree 

with that. 

However, my constituents are concerned when leaders in the tech 

space like Google suggest health sector is an unwelcome place for 

innovators. Frankly if that is true, millions of patients will be 

harmed, and this is a huge problem. 

Dr. Niloff, what can we do to attract more tech innovators into 

the health care space, and can Congress play a role in helping to 

create more certainty for innovators in the health care space? 

Mr. NILOFF. Yes, thank you. So, I think that there are two 

things. I think that the first thing reflects on my previous comment, is we need an environment that from a regulatory point of 

view that drives investment, and that is all around certainty about 

the future so that that doesn’t become a barrier, we don’t have, if 

you will, a risk premium on investments related to health IT. 

I think the second area is certainty or greater certainty about 

what the environment is going to be, the delivery environment is 

going to be, and how we are going to pay for health care in that 

environment, so that there is greater certainty around what the 

market is going to be for these innovations. 

And specifically I am referring to, from a congressional perspective, is that CMS with respect to the various programs that it promulgates defines the payment model, and the private sector commonly follows what is promulgated by CMS. Providers are challenged when they have to work in part fee for service world and 

part accountable care world, and you need to reach a tipping point 

where enough of your business is in the accountable care world, 

and I called it the coordinated care world, so it is worth making 

the investments in the technology to support that care model. 

76 

To the extent that collaboratively between the private sector and 

the public sector we can drive past a tipping point, where investments in technology make sense and are economically sound, we 

will both help our healthcare delivery systems be more viable and 

successful while at the same time driving better access, better 

quality, better patient safety, and more cost effective care. 

Mr. GREEN. Thank you. 

My colleagues, we have legislation called the Software Act to establish a commonsense approach to regulating mobile apps and 

other health information technologies under the FDA and our work 

is a work in progress, and our office has worked with Ms. 

Blackburn, Mr. Butterfield, Chairman Walden and others that 

takes into account the feedback we have received from various 

stakeholders over the last few months. 

And I would commend my colleagues on their leadership but also 

the important issue we could urge the chairman to address this in 

the 21st Century Cures, and that is what you just said is something I keep hearing. We need to have a payment system that reflects, are we going to go to the outcomes-based, or are we just 

going to continuing with the same pay for procedure, and maybe 

we need to provide leadership from that. 

Mr. Chairman, thank you for having this hearing. 

Mr. PITTS. The Chair thanks the gentleman. 

Now recognizes the gentleman from Georgia, Dr. Gingrey, 5 minutes for questions. 

Mr. GINGREY. Mr. Chairman, thank you, Chairmen Walden and 

Pitts, and thank you for holding today’s joint hearing on an important nexus within the jurisdiction of the full committee. 

I would like to focus my line of questioning on a topic that has 

been the focus of the committee for a long time. Ms. Eshoo was getting to that point as well. Innovation and health information technology, HIT. Dr. Niloff, you state in your testimony, and I quote, 

interoperable health IT is foundational to health care transformation. We cannot change the health care delivery model without it. Do you believe that we are on the path to interoperability, 

or are there changes to the law that we should consider as part of 

the 21st Century Cures Initiative? 

Mr. NILOFF. Thank you, sir. I believe that we are on the path. 

I think it is a challenging and long journey. I think we can help 

accelerate that path with some of the suggestions I made in the response to my last question. 

I think a good example of that is the work that we have accomplished with the Commonwealth Alliance where we have brought 

together essentially competitors to collaborate and work together to 

be able to move patients’ health information with their consent 

around a health care system. We have pilots in place today. It is 

working. We have tremendously positive feedback from both patients and providers, so I think, sir, that we are, indeed, on the 

path. 

Mr. GINGREY. Well, I agree with what you said, and I hope we 

are, but I am very concerned, the Rand Corporation report that 

was published last month found that the main electronic health 

record vendor, with over half of the stimulus dollars paid out to 

77 

medical providers going to their customers, was operating a closed 

platform which in essence means that they cannot be interoperable. 

And Congress has spent, as we all know, something like $24 billion over the past 6 years buying products to facilitate interoperability only to have the main vendor under the program, Epic, sell 

closed platforms. Do you believe that the Federal Government and 

the taxpayers are getting their money’s worth subsidizing products 

that are supposed to be interoperable but they are not? And I will 

ask any of the panel if they want to weigh in on that. Yes, Mr. 

Jarrin. 

Mr. JARRIN. If I may Congressman, thank you. 

One of the aspects that we have been pushing for when we discuss interoperability is medical device interoperability, and I mean 

very specifically home use medical devices because interoperability 

can be many things. Health information data exchange between 

electronic health records, that is one aspect, systems-wide within a 

hospital, and that would include high acute medical devices. That 

is another kind of interoperability. 

But when you leave a care facility, the electric health records incentive payment program right now that is run by CMS and the 

ONC which you have quoted, the $24 billion, I believe it goes all 

the way up to $27 billion, not really much of that really engages 

patients and families in their care. 

As part of the meaningful use stages, stage one, stage two, and 

stage three, in stage one they described that they were looking at 

potentially including uploading patient-generated health data into 

the electronic health record. That would be a way of interoperability. That happens right now because there are many companies 

that are actually doing that and allowing medical device that is are 

used at home, like wireless glucometers for example, wireless sensors on inhalers, et cetera. That information can go straight into 

a portal. It can easily go into an electronic health record, but that 

is not something that is happening at all and part of that is because the meaningful use stages have not actually stated that very 

directly. They should. 

Mr. GINGREY. Well Mr. Chairman, this committee has primary 

jurisdiction over the Office of the National Coordinator, ONC, and 

the HITECH Act that is responsible for the tens of billions of dollars being spent on non-interoperable products, if the June 2014 

Rand report is true, we have been subsidizing systems that block 

information instead of allowing for information transfers, which 

was never the intent of the statute. It may be time that this committee take a closer look at the practices of vendor companies in 

this space, given the possibility that fraud may be perpetrated on 

the American taxpayer. 

Furthermore, Mr. Chairman, as I see my time is elapsed, I would 

like to ask unanimous consent to include in the record an article 

from June 17, 2014, from iHealthBeat entitled, ‘‘Coalition Calls for 

Action Against EHRs That Block Interoperability.’’ That gets, I 

think, Mr. Chairman, to the very point I am talking about. With 

that I yield back, Mr. Chairman. 

Mr. PITTS. Without objection, so ordered. 

[The information follows:] 

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79 

Mr. GINGREY. And with that I yield back. Mr. Chairman, thank 

you. 

Mr. PITTS. The Chair thanks the gentleman. 

I now recognize the gentlelady from California, Mrs. Matsui, for 

5 minutes for questions. 

Ms. MATSUI. Thank you, Mr. Chairman. Thank you for holding 

today’s hearing. It is been very, very interesting listening to all of 

you. 

American innovation is transforming health care, integrating 

science, medicine and technology, to provide individuals with realtime access to vital health information, much of which was previously unavailable outside of a hospital or a doctor’s office. Smart 

phones are really creating pathways for virtual interactions between doctors and patients. Texting between doctors and patients 

is becoming more common. 

Now, telehealth is really at a critical juncture and increasingly 

becoming an integral component of the country’s healthcare system. But one of the challenges of implementing telehealth is that 

there is no consistent standard. What we have is an inconsistent 

and often dated patchwork of State laws. States are currently considering passing legislation addressing telehealth policies which 

means there is a wide variation in how telehealth is defined and 

this inconsistency hinders the national deployment of telehealth, 

hurting those who need care the most. 

And that is why I along with my colleague here on the committee, Representative Bill Johnson, introduced the Telehealth 

Modernization Act to create a workable definition for telehealth 

services. It provides a strong incentive for States to adopt consistent standards to remove the regulatory barriers to telehealth. 

Now, you know, we move forward with all this, too, I am listening to all of this, and I want to ask the question here of Mr. 

Misener. You talked about some of the ways that cloud computing 

is enabling medical research, and I think that cloud technologies 

are useful to foster innovation and research. 

And if we think really broadly, and I think about Amazon and 

all the data you have and all the information that you have and 

what you are doing now in the cloud, how can big data impact the 

healthcare sector and be expansive? And I would like to hear comments from the others, too. 

Mr. MISENER. Thank you, Ms. Matsui. I think there are a dozen 

or so examples that I offered in my written testimony, but generally I think you are right on point that cloud services are an enabler of the biomedical field both in discovery and development but 

also in delivery, so I have tried to give you examples in each. But 

one way to think about this is a researcher today is typically constrained to thinking about questions that he or she may address 

only with the computing power that they have available in their 

laboratory, and so they can’t think about big questions because 

they don’t have much computing capacity. 

But, if all of a sudden available to them on a temporary basis, 

however much or little they need, is computing power, they now 

can think about questions that are far beyond what their laboratory constraints impose upon them today. And so it really is an enabler of that discovery side of things, and it does again enable reVerDate Mar 15 2010 13:37 Aug 05, 2015 Jkt 037690 PO 00000 Frm 00085 Fmt 6633 Sfmt 6633 F:\113THCONGRESS\113162X21CTECHJKTREQ073115\113162X21CTECHPENDING W
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searchers, scientists, doctors, to focus on what they are best at and 

not have to worry about the technology that enables them. 

Ms. MATSUI. OK. 

And Dr. Riskin, I would like your comments, too. 

Mr. RISKIN. Sure. We are a big data company, so we see a lot 

of data. 

Ms. MATSUI. Right. 

Mr. RISKIN. One of our partners, a large health system sent us 

a million longitudinal records at one point recently and said we 

want to understand the association of concepts. 

If you have a disease, diabetes, and you take a drug, is there any 

correlation with an adverse event there. We didn’t have the processing power locally certainly to do that kind of effort. Fortunately 

we do work with Amazon and we have a good relationship with 

them, and we asked them can you spin up 100 servers and 20 

threads per server, and can we have massive processing power, and 

we crunched away at the numbers for a day. 

Ms. MATSUI. For a day. 

Mr. RISKIN. Cross referencing every concept with every other 

concept. There is a challenge here, it is powerful. You get information that you may not want to have, and we work closely with the 

large academic centers to understand what information is useful 

and what information is not and put useful information out into 

the community. But there is a great responsibility behind that kind 

of work. 

Ms. MATSUI. Absolutely. And would you be analyzing a lot of this 

data yourself, or are you going to, as you contract out with the 

other institutions, have them take that responsibility? 

Mr. RISKIN. In terms of what gets published, we think it is best 

for the health systems, the large academic centers, to create protocols and publish, so we can crunch numbers and support them in 

their protocol. In terms of internal development, we certainly use 

information to develop the next products to influence patient care. 

Ms. MATSUI. Do you see big data assisting in as far as the implementation as you get into the healthcare practices themselves 

down to the very ground level? 

Mr. RISKIN. I hope so. I don’t see that happening in the short 

term, a year or two, but I sure hope that happens in the long-term. 

It is one of the best approaches to reduce costs and improve outcomes in health care. 

Ms. MATSUI. OK. I thank you, and I went over my time. 

Thank you. I yield back. 

Mr. PITTS. The Chair thanks the gentlelady. 

Now recognize the gentleman from Ohio, Mr. Latta, 5 minutes 

for questions. 

Mr. LATTA. Well thank you, Mr. Chairman, and thanks so much 

to the panel for being here. It is been a very enlightening discussion that you have all given us today. 

And if I could start with Mr. Jarrin, in your written testimony, 

you stated that another important component of any 21st century 

technology for 21st century cures is spectrum, which is the lifeblood 

of our wireless networks. Mobile health solutions are part and parcel of an enormous surge in wireless data usage which is causing 

the spectrum crunch we are all now facing. 

81 

Now in this committee we have had many hearings, we have 

heard about the spectrum side and what is happening out there. 

One was that worldwide, by 2017, there would be 1.4 mobile devices per person across the globe. Well, that is not really going to 

happen because we know that in some areas of the globe of the 

technological challenges. 

But I was also in another meeting the other day where they 

thought by 2017 in the United States alone there would be seven 

per person. So when you look at the numbers that are happening 

out there and also what you want to be doing with this whole technology, what can Congress be doing to help on this whole spectrum 

crunch to make sure that the technologies can advance in the future on your end? 

Mr. JARRIN. Thank you. More spectrum is the lifeblood—spectrum is the lifeblood of mobile technologies and modern communications, modern wireless communications, and this committee 

and Congress in particular have actually shown a lot of leadership 

in trying to make more spectrum available. And when I mean spectrum, I mean licensed spectrum, shared spectrum, and unlicensed 

spectrum. 

I believe recently there was a bill introduced to help make more 

sense of the five gigahertz spectrum. We welcome that. M health 

is not unique to any particular band of spectrum. It is just going 

to add to the spectrum crunch. There was a task force that was put 

together by the former chairman of the FCC a few years ago which 

I helped be a part of, and one of the findings of the task force was 

that through radiological imaging and videoconferencing, spectrum 

is going to be really even taxed more within the next couple of 

years because this is what is expected out of some of the systems 

and some of the services that we are discussing. 

So the more that we have available spectrum, the better it is for 

the user because we are face a spectrum crunch. The FCC has been 

very honest about that. So it is something that we at Qualcomm 

take very seriously. We actually have an internal challenge where 

we are trying to maximize the use of spectrum 1,000-fold what we 

can today. Called the 1,000 X challenge, so I believe that Congress 

is really taking steps to do that, and thank you. 

Mr. LATTA. Thank you. 

Dr. Niloff, in the 21st Century Cures Initiative, the clinical trials 

process is one of the main focuses for the area, and, in my home 

State of Ohio, I have toured many of the premier research institutions across the State, and I have seen firsthand the important 

work that these individuals are doing to find cures for many different life-threatening diseases. Can you give us some examples of 

how these new technologies will assist with the clinical trial process and make it more effective and efficient? 

Mr. NILOFF. Sure. So I think that the first thing that is sort of 

the lifeblood of any trial is the identification of appropriate patients 

who would meet the criteria, specifically have the disease that is 

to be studied, and by having patient registries, having patients’ diseases codified as structured data in these electronic systems allows 

for the easy or more facile and rapid identification of the large populations of patients that you need as candidates for these trials. So 

82 

I think having that data available will expedite and increase the 

number of patients available for clinical trials. 

The second part in clinical trials, is the ability to follow patients 

longitudinally and have good reliable structured data about the 

course of their disease and the different parameters of their disease 

to understand if the treatment under study is effective or not effective and by having an electronic source of that data that captures 

the patients clinical status and the response to the treatment 

under study in a repeatable, standard way, is very helpful in assessing the outcomes of the study and the conduct of the trials. 

Mr. LATTA. Well thank you very much. 

And, Mr. Chairman, I see my time is about to expire, and I yield 

back. 

Mr. PITTS. The Chair thanks the gentleman. 

I now recognize the gentlelady from California, Ms. DeGette, 5 

minutes for questions. 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

I really want to thank the panel for this excellent presentation 

this morning. 

You might know that I am co-chairing this initiative with Chairman Upton, and oftentimes we have people come in and sort of talk 

vaguely about how great it would be to have a revision of the system, but you really came in with some specific suggestions, and we 

appreciate that as we look later this fall towards actually drafting 

legislation. 

I just want to follow-up with whoever wants to answer this on 

some discussion we have been having about interoperability. Everybody agrees interoperability is important, and we are striving for 

that even now under the system that we have. We are making 

some progress, but I frequently meet with smaller companies as 

well as individual physicians who are talking about electronic medical records, and the concern that smaller companies have is that 

they really don’t have the resources to work with patient data and 

to get that interoperability. 

And I am wondering, Dr. Niloff, Dr. Riskin, and also Mr. Vockell, 

if you can sort of address what we can do to incentivize this kind 

of interoperability throughout the system, not just with the larger 

players who can afford to do it? 

Mr. NILOFF. So I think that the solution to that is through collaboration, and it is not necessary for each individual company to 

reinvent the wheel multiple times, but through for instance the 

Commonwealth Collaboration that I referred to earlier is a mechanism where companies who might otherwise compete, be they large 

or small, can collaborate together and pool resources to develop 

technologies for interoperability that can then be broadly adopted. 

Ms. DEGETTE. Do you think there is any governmental role in 

making those things happen, Doctor? 

Mr. NILOFF. I think the Government role, again, at the end these 

solutions need to be paid for, and it all harkens back, if you will, 

to creating the economic environment and payment environment 

where the ultimate purchasers of the technology and the interoperability have a business case for purchasing it, which means aligning around a payment model, where having that technology makes 

83 

the providers successful in the payment model or care delivery 

model that they are operating under. 

Ms. DEGETTE. Dr. Riskin, do you have a perspective on this? 

Mr. RISKIN. Yes. Thank you. The question is a great one. There 

is a boundary between the electronic health record and the analytics system. 

Ms. DEGETTE. Right. 

Mr. RISKIN. When I work in the venture community in Silicon 

Valley, we look at opportunities, and there is very little coming 

through of new electronic health records. It is not where the new 

value is. The new value is in analytics and population health and 

patient engagement and we say for those companies to be successful, they need the data, so we will see company after company come 

in and say we are just going to have the data, and here is what 

we are going to do and we say that is not fundable because you 

can’t get the data. It is too expensive. 

So today, very expensive to get the data out. People are building 

custom interfaces into these electronic health records that is stifling innovation. There is a Government role here to say we paid 

for the data in the electronic health record, and here is the information we want out. Today’s approaches have very limited information for analytics and population health, ignoring the compliance issues and social issues and other things, so actually requiring 

broad data to be brought out would be powerful to promoting innovation. 

Ms. DEGETTE. Thank you. And Mr. Vockell, what about you? Do 

you have a view on this? 

Mr. VOCKELL. Yes. Earlier Mr. Gingrey talked about Epic and 

their slow path to making their information available and at the 

other end of the spectrum is Allscripts which has made a lot of 

their data available to third-party developers and the challenge has 

been that I believe Allscripts and some of the other providers have 

been told here is the format and the type of data you need to make 

available. 

And they look at their own system and they built it in an era 

that didn’t anticipate making that data available and so it is hard 

work for them to build to this outside set standard, and it makes 

them not include stuff that Dr. Riskin would find very valuable. 

A different approach could be you have to make your data in 

whatever format you currently have it available, and if you do, entrepreneurs will be all over building Rosetta Stones to translate it 

between the services. But since you are telling the slowest moving, 

ingrained, less hungry technology group to build to something, it 

is slow, and you know, Epic started a year and a half ago to build 

a public API, and it is barely out the door. 

Ms. DEGETTE. Thank you. 

Thank you, Mr. Chairman. 

Mr. PITTS. The Chair thanks the gentlelady. 

And I now recognize the vice chair of the full committee, Ms. 

Blackburn, 5 minutes for questions. 

Mrs. BLACKBURN. Thank you, Mr. Chairman. 

And thank you all for being here. We do appreciate the panel. 

The 21st Century Cures Initiative, the impact of technology in 

that is something that is incredibly important to our committee 

84 

and as you have seen from the questioning, we are working in a 

bipartisan way to address the needs that you all have, that patients have, and that the industry also needs. 

And being from Tennessee, we have appreciated the convergence 

and the impact of technology on health care delivery and do feel 

like that some of the answers for not only health care delivery, but 

patient quality of life, are going to be achieved through these devices. And I know Mr. Green mentioned to you all the software act 

that he and I are working on. Ms. DeGette has joined us in this 

effort, and we feel is part of the backbone and that is necessary. 

We are short on time. Votes are going to come up soon, so Dr. 

Niloff, I want to come to you and just have a couple of questions 

for you. The April 2014 FDAISA health IT report, are you familiar 

with that? 

Mr. NILOFF. Yes, I am. 

Mrs. BLACKBURN. OK. They have a framework that the ONC 

would among other things create a health IT safety working center. 

Are you familiar with that plan for regulating some forms of software and health IT? 

Mr. NILOFF. Yes, I am. 

Mrs. BLACKBURN. OK. All right, recently Chairman Upton and a 

couple of our colleagues and I wrote over to ONC to see where they 

think they are going to get this authority. And, have you seen that 

letter? Are you familiar with that? 

Mr. NILOFF. I am familiar with it—— 

Mrs. BLACKBURN. We got a response recently, and we felt like 

that they really don’t know where they have that authority, and 

like so many times agencies get into mission creep, and it concerns 

us. 

We feel like the FDA wants to regulate our medical app products 

as medical devices, and they are not. And Congress in its infinite 

wisdom decided in 1996 to update the FDA statute by creating the 

definition of a medical device in order to differentiate it from drugs. 

Before that time there was no statutory difference between the two. 

So just like drugs, software is not a medical device. Medical devices 

are not drugs, and we think it is necessary to put some clarity in 

this structure. 

So do you believe that Congress needs to get involved in the fix? 

Should we leave it to the FDA? Should we leave it to the ONC? 

Because it is beginning to us to look like a misguided system of 

regulation, and we don’t want this to run off the rails. So I would 

like to know what your guidance and your thoughts would be on 

this. 

Mr. NILOFF. So, when the Act was last updated, if you will, technology as we know it today did not exist, and I think could not 

even have been contemplated, so we live in a completely different 

technology environment today than when that Act was written. 

And I believe that the Act should be updated with the framework 

as described, a risk-based framework, so that we have clarity for 

the community, both today and clarity for the development community and the investment community going forward so we are in a 

stable environment that will allow for innovation and us to make 

good progress. 

Ms. BLACKBURN. I thank you for that. 

85 

Mr. Chairman, I think it is just vitally important that the FDA 

and the ONC work with Congressman Green and I as we work 

with the committee to come up with what a structure is going to 

be so that all of our low and moderate risk items can proceed to 

the marketplace, and things that are invasive and high risk have 

the oversight of the FDA, and that clarity is provided for this Nation’s innovators. 

With that, I yield back my time. 

Mr. PITTS. The Chair thanks the gentlelady. Now recognizes the 

gentleman from Louisiana, Dr. Cassidy, 5 minutes for questions. 

Mr. CASSIDY. Dr. Riskin, I have got some weird experiences here, 

man. I go to a banker’s office or a lawyer’s office, and they have 

fewer clerical workers because of computers. I go to a physician’s 

office, and they are hiring a data enterer and someone to train the 

data enterer because of computers. Clearly this is socking productivity. 

Now, both of you, Mr. Vockell and Dr. Riskin, suggested that 

there is minimal investment and little incentive on the interface 

side of it, whereas there is a heck of a lot on the back side. That 

is wrong. 

Now, when I speak to people, they wonder if the High Tech Act 

is not the problem; that by defining standards, we have stuck in 

amber certain systems, but as a doc, and I speak to docs whose 

productivity is down 25 percent, some of whom are taking the penalty. They are tired of looking at a computer screen instead of looking in a patient’s eyes. 

Do you agree with that assessment, that how the High Tech Act 

has been implemented is the—so to speak, we have met the enemy, 

it is us? 

Mr. RISKIN. Thank you, Dr. Cassidy. I appreciate the question. 

Mixed agreement, in that the—— 

Mr. CASSIDY. Speak quickly, please, because I have only got 3 

minutes now. 

Mr. RISKIN. The High Tech Act was powerful in terms of getting 

initial information in electronically, that is definitely needed, but 

the current processes of requiring information in certain ways has 

been excruciating for doctors. 

Mr. CASSIDY. So how do we unravel that? 

Mr. RISKIN. Probably the way to unravel is through usability. 

Mr. CASSIDY. Now, that is a little bit code for me. 

Mr. RISKIN. Yes. 

Mr. CASSIDY. When you say ‘‘usability,’’ what do you mean? 

Mr. RISKIN. The challenges, the doctor who is entering data right 

now, or their proxy, finds they are putting in information that isn’t 

that useful, or they are being forced to put in information around 

billing that isn’t clinically relevant. More of a focus on how can the 

systems be useable and how can we get the information—— 

Mr. CASSIDY. I get that. So there is an incentive apparently right 

now, I spoke of I am told it is stuck in amber. Entrepreneurs don’t 

have any incentive to go in this space. Mr. Vockell just kind of suggested that. So what I am really asking is how do we once more 

incentivize these entrepreneurs to begin to do this as oppose—you 

know, get rid of the amber, so to speak. 

86 

Mr. RISKIN. So to solve the data usability problem, the data entry 

problem, the incentive would require that EHR’s be usable and the 

EHR’s would then need to work with companies to create usability. 

Right now there is—— 

Mr. CASSIDY. I accept that, but you can’t just mandate from on 

high, Washington likes to think it can do so, make it useable. 

There has to be some penalty not doing so and there has to be 

some reward for doing so, not upon the doc, because the doc’s already being penalized. 

Mr. RISKIN. Agreed. And the physician community is less and 

less capable to push for useable systems. 

Mr. CASSIDY. So, Mr. Vockell, what would you say to that, because you are nodding your head you are in agreement, but I am 

not sure I have understood yet how we get back to the entrepreneur in caring about this area. 

Mr. VOCKELL. I think you have hit on what is the economic incentive. And right now there is no way for a doctor to translate, 

I could free up 25 percent of my time and see more patients or deliver a higher quality of care. And so if the payments that the physician were able to receive or the way that they were compensated 

was linked to the quality outcomes like—— 

Mr. CASSIDY. No. But, see, I am not making my point. The doc 

is willing to do this. The doc has taken the 25 percent hit. The doc 

is hiring the scribe at $12 an hour plus benefits. So I actually don’t 

think it is the doc’s problem; I think it is the vendor, if you will, 

who is not creating the interface, because they are either not required to or there is no reward. Why not just foist it off upon the 

doc as opposed to us taking the lumps. I mean, do you see my 

point? 

Mr. VOCKELL. Yep. And I think they don’t have the incentive, because there is such high switching costs to go from one system to 

another that—— 

Mr. CASSIDY. So how do we create that incentive? 

Mr. VOCKELL. I think it is—I don’t know how you will get an 

EHR to require to make their data interoperable, because that is 

the barrier to switching. 

Mr. CASSIDY. Do you agree with the critic that says the way that 

ONR has instituted this program does stick in amber so that the 

companies like Epic can get high market share, but they have little 

incentive in order to create that better user interface? 

Mr. VOCKELL. Yes. It makes them work towards the data center, 

yes. 

Mr. CASSIDY. You agree with that? 

Mr. VOCKELL. Yes. 

Mr. CASSIDY. Let me ask one more thing. I read your testimony 

and didn’t quite gather. You said there are strong economic disincentives for people to share data, but I didn’t see you amplify 

that. What are those economic disincentives? 

Mr. VOCKELL. So if you ask Humana to give you a data set around linked co-morbidities or protocols, it will cost you $500,000, 

because that is what they charged Pfizer for it. And so if you are 

a startup, or even a data analytics company who is trying to add 

a relevant data set that only payers have, you can only do it if you 

have got a half a million bucks. 

87 

Mr. CASSIDY. Gotcha. Thank you. I am out of time. I appreciate 

it. 

Mr. PITTS. The Chair thanks the gentleman. Now recognizes the 

gentlelady from North Carolina, Mrs. Ellmers, 5 minutes for questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman. And thank you to our 

panel. 

Dr. Niloff, I am going to direct my question to you in the interest 

of time. We were just discussing—you know, kind of following up 

on some of the discussion, we were talking—I certainly see all the 

benefits to patients on health IT. You know, this really is an area 

that—of obviously much needed into the future, but there again, 

keeping in mind that we know that there are all the positives, 

what are the barriers? And I think we were just talking about 

some cost issues here for integrating the systems. Do you see this 

as an issue too, and are there other barriers that we need to be 

aware of? 

Mr. NILOFF. Sure. So I think that the main barrier and the main 

challenge today as we have discussed is interoperability and continued innovation. And I think that we need to have the right payment model in place to drive the purchase of these systems. We 

need our delivery systems to have sufficient alignment of their different contracts that they are operating under so they are doing 

population health, coordinating care on a significant portion of 

their population, that they can make the investment both programmatically and technologically in these type of things, because that 

will drive innovation as the market grows. 

Mrs. ELLMERS. And when you say ‘‘they,’’ are you talking about 

the physician themselves or are you talking about—— 

Mr. NILOFF. I am really talking about at the health system level. 

Mrs. ELLMERS. OK. 

Mr. NILOFF. I think much of this technology, because physicians 

are now working in organized systems of care where they are part 

of an integrated network, and we are really driving to coordinate 

care from the in-patient arena to the outpatient arena, to long-term 

care, that really what we are talking about is health systems making purchases of technology, and not just electronic medical record 

technology, but enterprise registries to drive preventive care and 

manage patients with chronic illnesses, care management systems, 

where they use technology to identify high-risk patients and then 

have skilled nurses manage those patients, that those are the types 

of technologies and related programs that are ultimately really 

going to drive us to a delivery system which is going to drive real 

improvements in health. 

Mrs. ELLMERS. So that would be, too—you know, just actually 

playing into another question, so I am just assuming that that is 

kind of the path that you see us taking as we are looking for the 

21st century cures, and how we as legislators and here how we in 

Congress can help that effort, obviously you see that as an effort, 

too, when we are moving towards advancements in medical technology and curing disease and moving forward that way? Is 

that—— 

Mr. NILOFF. Yes. You know, I think that it would be helpful if, 

as Congress considers sort of health care for the 21st century, that 

88 

they think about health care in the context of not how we are delivering care today, but in a framework that thinks about the context 

of how we are going to deliver care in the future in a more optimal 

model; think about how we are going to have systems of care where 

everybody talks to each other, where when a patient moves from 

the hospital to a skilled nursing facility, their record moves with 

them, and it is not, you know—it is not—I am thinking about a 

family instance, but where, you know, an 80-some-year-old mother 

ends up having to be the major coordinator of care for her 93-yearold husband, because it is not happening electronically and the 

health system can’t manage it. 

And I think that what we have to think to is what sort of care 

model system of care that we are going to move to that makes it 

not just better care, but better experience for patients and families, 

and how Congress can modify the law to drive that type of system 

of care, which will benefit all Americans. 

Mrs. ELLMERS. Thank you, Dr. Niloff. 

And thank you, Mr. Chairman. I yield back the remainder of my 

time. 

Mr. PITTS. The Chair thanks the gentlelady. And now recognizes 

Mr. Butterfield, 5 minutes for questions. 

Mr. BUTTERFIELD. Thank you very much, Mr. Chairman. And 

thank all of the witnesses for their testimony today. I want to commend you, Mr. Chairman, for the subject for the hearing today, 

21st century technology for 21st century cures. I like that, and I 

hope that as the session that moves along this year, we can continue to develop some ideas. 

To all of the witnesses, and I can’t call on each one of you, but 

whoever feels the most comfortable, I would ask that you respond. 

We know that certain population segments, including seniors and 

Americans with disabilities, are less likely, less likely to adopt 

broadband at home. Do the broadband enabled innovations that we 

have discussed today help these Americans get online and receive 

all the benefits of the applications we are discussing today? 

That is not fair to you. I guess I should have called on one or 

two, but let’s do it this way, and then I will call on someone next. 

Mr. JARRIN. Sure. So the answer to big data, you know, when we 

are talking about big data, and I hear the theme coming up quite 

a bit today, part of that is connectivity. Without connectivity, there 

is no real big data, whether it is wired, wireless or mobile. Increasingly, it is becoming mobile, and that is obviously represented in 

the figures I gave at the beginning, 355 million users in the U.S., 

7 billion in the world. 

So I believe that through, you know, products like those of Amazon, products like the chipsets that Qualcomm produces and go into 

those products, those consumer facing devices, et cetera, they are 

getting out there. I believe the FCC quoted that over 95 percent 

of the country is now covered by at least one mobile broadband provider. More needs to be done, both on spectrum. Also I know that 

the FCC is working hard towards reaching disparate populations 

through their rollup broadband program, but I believe that we are 

getting there. We are getting there. 

Mr. BUTTERFIELD. All right. We have a buzzer to go to the floor, 

so I will just ask one more, Mr. Chairman. 

89 

Telehealth programs are critical to communities in rural areas 

like my district in eastern North Carolina. East Carolina University, for example, has set up a telehealth opportunity at clinics 

throughout many rural communities that enable constituents to receive specialized medical care without traveling long distances. And 

I know all of you are familiar with this and you are looking forward to the next generation of technology. 

What are the major challenges, such as broadband access, that 

rural communities face in fully utilizing telehealth opportunities? 

If each one of you could just do a couple of sentences, starting with 

Mr. Vockell. 

Mr. VOCKELL. Well, I think probably they are more qualified 

down there, but I think mobile devices are beginning to take over 

what that capacity is. It is less, you know, cables into the home 

and it is what used to be wired is now wireless. So as the 

Qualcomm guys continue to do their good work and 1000X the 

bandwidth. 

Mr. MISENER. If you wanted me to answer, Mr. Butterfield. 

Mr. BUTTERFIELD. Sure. 

Mr. MISENER. Mr. Jarrin is exactly right. Connectivity is the key. 

And we have always heard, at least for the past two decades, that 

telehealth was going to be a major driver of the need for 

connectivity in rural areas, and now it is here. So I think the concept of ensuring broadband deployment nationwide, including in 

rural areas is extremely important, not just for telehealth, but especially for it. 

Mr. RISKIN. The answer, from my perspective, I actually have an 

appointment in a safety net hospital. I am very familiar with the 

access issues that occur. And I would say connectivity is critical, 

but patient engagement is just as difficult. Whatever modality you 

are using to reach your provider, if the patient isn’t engaged in 

their care, and typically rural or safety net communities are more 

difficult to engage, they won’t be able to work with that modality. 

Mr. JARRIN. And I know that we are almost out of time, but one 

thing that I would like to mention: So Qualcomm sponsors many 

things. We have a program called Wireless Reach. One of our recent projects was delivering care in a Native American area near 

Flagstaff, Arizona. And there were issues with being able to get 

mobile broadband in those areas. There was no connectivity whatsoever, but there were—there was one operator in particular that 

actually was able to reach this population. And what we did was 

we provided telephones, mobile, smart phones that connected with 

home use medical devices such as medical grade weight scales and 

blood pressure cuff monitors. And what happened was that a person with congestive heart failure would use these devices, it would 

connect with the smartphone, go into the hospital, and then a series of nurses and other care providers would actually develop a 

work flow and be able to inform the patient of when things were 

going badly. We were able to reduce hospital readmissions through 

that very well. 

Mr. BUTTERFIELD. The chairman is tapping on his microphone. 

That is our—— 

Mr. JARRIN. Unlimited broadband is a very important thing 

for—— 

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Mr. BUTTERFIELD. I get it. Thank you. 

Mr. PITTS. The gentleman has time expired. We are in the middle of a vote. We have got 10 minutes left. We are going to try to 

finish here. Mr. Griffith, you are recognized 5 minutes for questions. 

Mr. GRIFFITH. Thank you very much, Mr. Chairman. 

Thank you all. This have been a very educational hearing. As 

you can hear, there is bipartisan support for trying to figure out 

how we go forward. I have heard all kinds of things. You know, figuring out the payment model when we are using new devices that 

you may not even have to go in to see the doctor on and electronic 

health records. 

My concerns parallel those of Ms. Blackburn when she talked 

about devices. It was sometime a year, a little over a year ago, we 

had an FDA representative in here, and I asked them about this 

$8 hack that had been used in Africa to send photographs to a hospital in the United States. You had a team of Canadian and I think 

Swiss doctors working on it, and they were able to identify a parasite out of the stool of children and get a diagnostic fix figuring out 

which parasite it was and do the treatment the next day. I said, 

would this be a medical device? And the answer was, yes. If it is 

diagnostic, it is a medical device, even though all they were doing 

was taking a picture on a smartphone with an $8 hack. Because 

it was being used diagnostically, the FDA thinks it is a medical device. 

So I think it is very important that we pass language that we 

can approve in a bipartisan way that clears that up so that, as she 

said in her statement earlier today, if it is a truly—you know, 

something that is invasive, we want FDA making sure it is safe, 

if it is just diagnostic, we want to make sure that we get it to the 

market. 

And, Mr. Jarrin, I noticed, and it is in your written testimony 

and in your oral testimony, you mentioned like 15 devices that you 

could use that would give you some diagnostic capabilities without 

the healthcare provider being present. Are you all finding that 

FDA’s worried about that or spending a lot of time on that? 

Mr. JARRIN. Well, actually the X PRIZE included the FDA originally, so that way we wouldn’t land into those issues and lack that 

clarity, because that was definitely an issue that we were considering, whether or not this would be obviously a medical device. So 

the FDA joined the project early on. I believe that Dr. Shuran, who 

may have been the person that you were referring to, actually even 

put a video on the FDA Web site about their involvement with the 

X PRIZE. So I am hoping that when everything is said and done, 

you know, we will all be on the same page. 

One thing that I would mention, you have an excellent example 

of the kind of clarity that was needed and still needs—there is 

never enough, right? 

Mr. GRIFFITH. Right. 

Mr. JARRIN. Because that exact example is something that they 

actually ended up putting into the draft—the final guidance by saying that those mobile apps that can be used to visually augment, 

you know, whatever a provider is dealing with in a diagnosis would 

not be regulated under their enforcement discretion. So, you know, 

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it was very helpful. Again, Congress was very helpful, because 

when you ask those questions, I believe the agencies really do pay 

attention and listen, and the FDA in that very specific instance did 

exactly that. You know, they did release the mobile medical apps 

guidance document. I believe that FDASIA tries to deregulate 95 

percent of what they—what they say very specifically, most CDS 

products and mobile medical apps and health IT software, but now 

it needs to be codified. 

Mr. GRIFFITH. I might need to cut you short, because I have got 

to leave a little bit of time for Mr. Bilirakis to get a question or 

two in. 

I would say that not only is that important, I am glad that they 

were listening, but the telemedicine is going to be very important. 

I represent a rural district, and it is going to be extremely important in the rural parts of this country. 

Thank you so much. With that, Mr. Chairman, I yield back. 

Mr. PITTS. The Chair thanks the gentleman. Now recognize Mr. 

Bilirakis. 5 minutes for questions. 

Mr. BILIRAKIS. Thank you. I appreciate it, Mr. Chairman. And 

thank you, Mr. Griffith, for keeping it short. I really appreciate it. 

I want to go quickly, too. 

With regard to the cloud, unfortunately, 10 percent of the agencies who adopt the cloud in the Federal Government, so it hasn’t 

really been a success on the Federal level, unfortunately, but in the 

private sector, the private sector has rapidly adopted cloud-based 

solutions. And I know Representative Matsui actually touched 

upon this, but I have a couple questions. 

What are some of the barriers to the adoption and expanded use 

of cloud-based computing and cloud-based storage in the medical 

space, and how can we facilitate the expanded use of cloud? What 

are some of the laws that need to be examined, because of the way 

they interact with the cloud computing? 

And anyone on the panel can respond. Doctor? 

Mr. VOCKELL. The cloud expert to start, probably. 

Mr. MISENER. Well, thank you, Mr. Bilirakis. I appreciate that. 

In our experience with Amazon Web Services, the take rate isn’t 

as great as we would like it to be with Government agencies, but 

it is changing, and as I mentioned in my testimony, we already 

serve many around the world, but in the Federal Government, 

there are areas where Congress could lead by example, either 

through legislation or working in their oversight role over agencies 

to ensure that agencies do use cloud when it makes sense to. 

Right now, sometimes agencies feel constrained to buy only traditional hardware and software and pay their own in-house people to 

run it, and that turns out to be highly inefficient, and so hopefully 

Congress, through the two acts that I mentioned in my testimony, 

including FITARA, could encourage the Government use of cloud, 

to the benefit of our taxpayers, of course. Thank you. 

Mr. BILIRAKIS. Anyone else on the panel? OK. I will get on to the 

next question. 

With regard to the medical devices in the dialysis world, they 

have remained largely unchanged, you will agree with that. If you 

were to need kidney dialysis, you would basically be using the 

same devices your parents were using. There have not been any 

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large innovations in that space. However, in the world of consumer 

electronics, there have been continued innovations in this space. 

Televisions today are radically different from televisions in the 

1990s, cell phones today are different than they were, the ones in 

the 1990s, tablet PCs are different than the laptops and notebooks 

from the past decade. 

So my question is, How is it that we can have rapid innovation 

in consumer electronics with lower costs for consumers, but slower 

innovation with higher costs in the medical space? Is it the cost of 

the excessive regulation? Is it the higher barrier to entry? How do 

we encourage shaking up the status quo? 

And whoever would like to begin, please. 

Mr. JARRIN. I actually will take it only because I am aware of 

a pilot project that is actually part of the Center for Medicare and 

Medicaid innovation challenge grants which is being conducted at 

the George Washington University Hospital in consult with a company named DeLier and a company named Baxter and a number 

of other partners, and it deals with kidney dialysis in one way or 

another. So I believe that that community is definitely listening. 

They are really looking into things like remote patient monitoring, 

et cetera. 

But if I step back for a moment, I think one of the largest barriers to adoption for this entire field are the outdated rules that we 

have governing reimbursement for services, particularly when we 

talk about remote patient monitoring, it automatically gets lumped 

into something called telehealth reimbursement, and it is not necessarily the same thing. Under the telehealth rules, you have to 

start off from an originating set of care that CMS stipulates; it has 

to be a specific disease condition, there is only about 20 or 25 of 

them; and it can’t happen in a metropolitan statistical area, it has 

to happen in a health shortage area; it has to be live voice and 

video, which removes automatically all the stuff that we are working on. It is incredibly restrictive. 

So according to the American Telemedicine Association, doctors 

are only able to access between 5 and $8 million—with an M— 

worth of reimbursements for telehealth consults. You know, the 

CMS budget is near $800 billion, so I would pause to think that 

some of that could by targeted towards incentivizing the uses of 

these types of equipment and services, because the issue is this: If 

I am a hospital or I am a health plan, if I am not being reimbursed 

by my largest population, which happens to be Medicare, I am not 

going to be incentivized to adopt those technologies that I am not 

being paid to use, or to provide services that I am not going to be 

paid to provide. 

So I think that is a real huge barrier to adoption. And then that 

folds into, of course, the incentive payment program, which has 

done a good job of incentivizing the use of electronic health records, 

but there is no aspect that actually allows for patient-generated 

health data to go into that electronic health record, so the patient 

is really literally cut out, except when he walks into the facility, 

and then you have got the situation that your colleague was mentioning where we have the scribe, you know, typing stuff in while 

the doctor and the patient discuss their care. So it is a real complex 

issue, but I think that I those are barriers to adoption. 

93 

Mr. BILIRAKIS. Thank you very much. Thank you, gentlemen, for 

your testimony. 

I yield back, Mr. Chairman. 

Mr. PITTS. Thank you. 

Thank you again to the witnesses for sharing your expertise. 

This has been a very informative hearing. I am sure members will 

have a lot of follow-up questions. We will submit those to you in 

writing. We ask that you please respond promptly. 

I remind members that they have 10 business days to submit 

questions for the record. Members should submit their questions by 

the close of business on Thursday, July 31st. 

Another very important, informative hearing. Thank you very 

much. Without objection, this subcommittee is adjourned. 

[Whereupon, at 12:21 p.m., the subcommittee was adjourned.] 

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