U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001

80–806 2013

HEALTH INFORMATION TECHNOLOGIES: HOW 

INNOVATION BENEFITS PATIENTS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON HEALTH 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

MARCH 20, 2013 

Serial No. 113–21 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

(II) 

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, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

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 

(III) 

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

of Pennsylvania, opening statement ................................................................... 1 

Prepared statement .......................................................................................... 2 

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

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

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 4 

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

California, opening statement ............................................................................. 6 

Hon. Phil Gingrey, a Representative in Congress from the State of Georgia, 

prepared statement .............................................................................................. 163 

WITNESSES

Joseph M. Smith, M.D., Ph.D., Chief Medical and Chief Science Officer, 

West Health Institute .......................................................................................... 8 

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

Answers to submitted questions ...................................................................... 170 

Christine Bechtel, Vice President, National Partnership for Women And Families ........................................................................................................................ 67 

Prepared statement .......................................................................................... 69 

Jim Bialick, Executive Director, Newborn Coalition ............................................ 74 

Prepared statement .......................................................................................... 76 

Answers to submitted questions ...................................................................... 173 

Jacqueline Mitus, M.D., Senior Vice President, Clinical Development and 

Strategy, McKesson Health Solutions ................................................................ 83 

Prepared statement .......................................................................................... 85 

Answers to submitted questions ...................................................................... 177 

David Classen, M.D., Chief Medical Information Officer, Pascal Metrics, and 

Associate Professor of Medicine and Consultant in Infectious Diseases, University of Utah School of Medicine ..................................................................... 130 

Prepared statement .......................................................................................... 132 

Answers to submitted questions ...................................................................... 179 

SUBMITTED MATERIAL

Letter of March 20, 2013, from Kevin McCarthy to the Committee, submitted 

by Mr. Pitts ........................................................................................................... 164 

Statement of The Bipartisan Policy Center, submitted by Mr. Pitts .................. 166 

(1) 

HEALTH INFORMATION TECHNOLOGIES: HOW 

INNOVATION BENEFITS PATIENTS 

WEDNESDAY, MARCH 20, 2013 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON HEALTH, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:00 a.m., in room 

2123 of the Rayburn House Office Building, Hon. Joe Pitts (chairman of the subcommittee) presiding. 

Present: Representatives Pitts, Burgess, Hall, Shimkus, 

Blackburn, Gingrey, Lance, Guthrie, Griffith, Bilirakis, Ellmers, 

Pallone, Green, Barrow, Christensen, Sarbanes, and Waxman (ex 

officio). 

Staff present: Clay Alspach, Chief Counsel, Health; Matt Bravo, 

Professional Staff Member; Debbee Hancock, Press Secretary; 

Sydne Harwick, Staff Assistant; Sean Hayes, Counsel, Oversight 

and Investigations; Robert Horne, Professional Staff Member, 

Health; Carly McWilliams, Legislative Clerk; Andrew Powaleny, 

Deputy Press Secretary; Chris Sarley, Policy Coordinator, Environment and the Economy; Heidi Stirrup, Health Policy Coordinator; 

Alli Corr, Democratic Policy Analyst; Eric Flamm, FDA Detailee; 

Amy Hall, Democratic Senior Professional Staff Member; Elizabeth 

Letter, Democratic Assistant Press Secretary; Karen Nelson, Democratic Deputy Committee Staff Director for Health; Rachel Sher, 

Democratic Senior Counsel; and Matt Siegler, Democratic Counsel. 

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

OF PENNSYLVANIA 

Mr. PITTS. The subcommittee will come to order. The chair will 

recognize himself for an opening statement. 

Today’s hearing is part of a series of Energy and Commerce subcommittee hearings this week that focus on health, technology and 

innovation. 

In the last few years, health information technologies, including 

mobile medical applications, electronic health records, personal 

health records, computerized health care provider order entry systems, and clinical decision support, have transformed the provision 

of health care in this country. Electronic health records hold great 

promise for the delivery of care given and the quality of care received in this country. They have also been identified as key components of future payment reforms such as those envisioned for 

medical providers under the SGR. 

2 

There are now mobile medical apps for wireless thermometers, 

apps that calculate body mass index, apps that track the number 

of miles a runner has jogged and those that can wirelessly transmit 

data to wearable insulin pumps. These apps can range from the 

complex, like mobile cardiac outpatient telemetry that uses wireless sensors, to those that allow users to count calories. 

To give you a sense of the scope of their importance, it has been 

estimated that 500 million people will be using medical apps by the 

year 2015. Therefore, it goes without saying that these technologies 

hold great potential for patients and providers. However, with the 

proliferation of these technologies have come concerns about how 

their use may negatively impact patients. Some have argued that 

federal oversight of these health information technologies is important to safeguard patients from malfunctioning technology. 

In response to these concerns, the Office of the National Coordinator in December of 2012 put out a proposal for a risk-based regulatory scheme for electronic health records that sought to address 

the needs of Americans both as consumers and patients. The Food 

and Drug Administration has also put forward a proposal, in the 

form of draft guidance issued in July 2011, indicating its intent to 

regulate certain apps as medical devices under section 201(h) of the 

Federal Food, Drug and Cosmetic Act. 

While FDA’s attention to the needs of patients is commendable, 

its action requires very close scrutiny. This subcommittee has examined in the past the negative impacts that FDA regulation, with 

its uncertainty, high costs, and long approval times, has had on the 

medical device industry. If we allow the same to happen in this 

space, such negative impacts could cripple a still evolving and 

promising industry, where the average developer is small and the 

cost of these apps is relatively inexpensive. 

Some have also raised concern that the FDA may further expand 

the definition of ‘‘medical device’’ in the future to include other 

technologies, such as smartphones or tablets, and thus the medical 

device tax passed in the Patient Protection and Affordable Care Act 

could apply to them. 

Therefore, this hearing is an appropriate place to examine the 

extent to which the FDA and other federal agencies should be involved in regulation of health information technologies and what 

such a regulatory framework might look like. 

With these thoughts in mind, I want to thank our witnesses for 

being here today and look forward to their testimony. 

[The prepared statement of Mr. Pitts follows:] 

PREPARED STATEMENT OF HON. JOSEPH R. PITTS

Today’s hearing is part of a series of Energy and Commerce subcommittee hearings this week that focus on health, technology and innovation. 

In the last few years, health information technologies, including mobile medical 

applications (apps), electronic health records, personal health records, computerized 

health care provider order entry systems, and clinical decision support, have transformed the provision of health care in this country. 

Electronic Health Records hold great promise for the delivery of care given and 

quality of care received in this country. They have also been identified as key components of future payment reforms such as those envisioned for medical providers 

under the SGR. 

There are now mobile medical apps for wireless thermometers; apps that calculate 

body mass index; apps that track the number of miles a runner has jogged and 

3 

those that can wirelessly transmit data to wearable insulin pumps. These apps can 

range from the complex, like mobile cardiac outpatient telemetry (MCOT) that uses 

wireless sensors, to those that allow users to count calories. To give you a sense of 

the scope of their importance, it has been estimated that 500 million people will be 

using medical apps by 2015. 

Therefore, it goes without saying that these technologies hold great potential for 

patients and providers. However, with the proliferation of these technologies have 

come concerns about how their use may negatively impact patients. Some have argued that federal oversight of these health information technologies is important to 

safeguard patients from malfunctioning technology. 

In response to these concerns, the Office of the National Coordinator in December 

2012 put out a proposal for a risk-based regulatory scheme for electronic health 

records that sought to address the needs of Americans both as consumers and patients. 

The Food and Drug Administration (FDA) has also put forward a proposal, in the 

form of draft guidance issued in July 2011, indicating its intent to regulate certain 

apps as medical devices under section 201(h) of the Federal Food, Drug and Cosmetic Act (FFDCA). 

While FDA’s attention to the needs of patients is commendable, its action requires 

very close scrutiny. This subcommittee has examined in the past the negative impacts that FDA regulation—with its uncertainty, high costs, and long approval 

times—has had on the medical device industry. If we allow the same to happen in 

this space, such negative impacts could cripple a still evolving and promising industry, where the average developer is small and the cost of these apps are relatively 

inexpensive. 

Some have also raised concern that the FDA may further expand the definition 

of ‘‘medical device’’ in the future to include other technologies, such as smart phones 

or tablets, and thus the medical device tax passed in the Patient Protection and Affordable Care Act could apply to them. 

Therefore, this hearing is an appropriate place to examine the extent to which the 

FDA—and other federal agencies—should be involved in regulation health information technologies and what such a regulatory framework might look like. 

With these thoughts in mind, I want to thank our witnesses for being here today 

and look forward to their testimony. 

Mr. PITTS. And no one is seeking recognition. I will close my 

statement and recognize the ranking member of the Subcommittee 

on Health, Mr. Pallone, for 5 minutes for his opening statement. 

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. 

Today is an important examination of the ways in which health 

information technologies can benefit patients, doctors, and the 

health care system as a whole. HIT is an absolutely essential underpinning to the future of delivery and payment reform. 

The notion that if we can improve the coordination of care, patient safety, disease management, and prevention efforts, we can 

save money for the entire system. It is not baseless. In fact, it has 

the utmost merit. Modernizing our health care system and moving 

into an electronic era is part of a national conversation that is occurring, and politicians of both political parties, providers, and patients all agree that HIT holds tremendous promise for improving 

the performance of our healthcare system in a way that will increase access, enhance quality, and indeed lower costs. 

That is why as chairman of this subcommittee, I worked alongside many of my colleagues, Democrat and Republican alike, and 

we passed the Health Information Technology for Economic and 

Clinical Health Act, otherwise known as HITECH or the HITECH 

Act. Together, we recognized with that bill that there was a need 

4 

for the Federal Government to commit to expanding the use of information technology in the health care sector, and that its widespread adoption would have significant long-term benefits. This 

critical law contained unprecedented funding to promote the adoption of health information technology among hospitals, doctors, and 

health care providers through initiatives by the Office of the National Coordinator of HHS and through Medicare and Medicaid incentives. This historic investment has begun to help modernize our 

Nation’s use of technology to truly ensure a high-performing 21st 

century health system, and in building an infrastructure of fundamental change. 

The truth is that we have made great progress so far, and there 

are even more opportunities that will be realized in the future 

through the implementation of this law. As a result of these programs, electronic health records, EHRs, and meaningful use of 

those records has increased dramatically in recent years, and we 

will hear today from some of the witnesses how it is working to 

make life better for patients and serving as a catalyst for innovation. 

Now I am afraid that my Republican friends are going to spend 

this day making up false stories about how the Affordable Care Act 

and FDA regulation is stifling innovation—how our smartphones 

are going to be taxed and Apple’s manufacturing plants will be inspected, but I have to say this is nonsense. The reality is the future 

of mobile health is very bright. In fact, there is an effort underway 

by the Federal Government to open up large sets of data to be used 

by developers to create these mobile applications, and many of 

these apps are designed to assist both individuals and health care 

providers in managing health care decisions and delivery. One industry analyst estimates that the total revenues of the mobile medical app market will grow to $26 billion by 2017, and because of 

the HITECH Act, this open data will be able to be networked and 

shared with providers to improve patient health and lower costs. 

But I believe, and I think all of our witnesses today will agree 

with me, that if a technology developer is going to make healthbased claims, then there must be a role for FDA to ensure it is safe 

and effective, and I hope that is what comes out of today’s hearing 

is a better understanding of how the successful adoption of health 

information technology will have a transformative effect on the 

quality of health care in the United States, as well as the economy 

of health care. 

So I thank you all, thank the chairman, and I would yield back 

the balance of my time. 

Mr. PITTS. Chair thanks the gentleman, and now recognizes the 

vice chair of the subcommittee, Dr. Burgess, for 5 minutes for an 

opening statement. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. I thank the chairman for the recognition. I am 

grateful to the chairman for holding this hearing, grateful to our 

panel for presenting to us today. 

The title of the hearing is fitting. As somebody who worked in 

health care, I recognize the benefit that innovation brings to paVerDate Nov 24 2008 13:42 Sep 13, 2013 Jkt 037690 PO 00000 Frm 00010 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-21 CHRIS
5 

tients. From the newest means to detect and diagnose conditions, 

to the cures and diseases that once were thought untreatable, innovation has led the way to bettering the lives of patients. 

Health care innovation doesn’t always lower costs, but it always 

holds the potential to improve the quality of life and therefore is 

a goal worth pursuing in and of itself. 

The tools that future doctors will have at their disposal will be 

unparalleled in the history of medicine for their ability to alleviate 

human suffering and improve lives, but we need to get the tools in 

their hands. From custom biologics to nanotechnology to the promises of the human genome, we are on the cusp of a medical revolution. The President, in an Executive order, ordered federal agencies 

to review and remove outdated regulations. I absolutely agree with 

Mr. President, but the proof really remains to be seen. 

The biggest impediment to innovation is the uncertainty of regulation. If the Federal Government thinks about regulating something, that almost always means it is planning to over-regulate. 

There is the difficultly, because the lifeblood of innovation, venture 

capital, will be drained away from the cures that might have been. 

As a doctor, first do no harm. I don’t want to do anything that 

will harm a patient. But while the FDA struggles with their core 

requirements that they propose to venture into new areas like mobile apps and research only products and health information technology, it really does require a soft touch. Instead of talking to 

stakeholders, including members of Congress, where updates may 

be needed from time to time, and significant proposed regulatory 

changes could stop innovation in their tracks, we are just not seeing it happen. Companies will build it, doctors will use it, patients 

will benefit if we could just get out of the way and ensure responsible regulation in a timely fashion. 

The reason I care about this so much is because not just today, 

this is about the future. This is about the men and women that will 

follow after us in the practice of medicine. These are about the 

ideas that somebody hasn’t even had yet. The lack of a reliable and 

consistent regulatory process signals an inability to handle the 

events for technology in the future. 

Mr. Chairman, this hearing is timely. It is in conjunction with 

other hearings being done in other subcommittees and the full committee. Technology had a hearing yesterday. We will have a hearing in Oversight and Investigations tomorrow. But it is part of a 

process. 

I would like now to yield the balance of the time available to the 

gentlelady from Tennessee, the vice chair of the full committee. 

Mrs. BLACKBURN. I thank the gentleman for yielding, and welcome to each of you. We are delighted that you are here. 

As Dr. Burgess said, we had a Telecom Subcommittee hearing 

yesterday, and looked at the impediments to innovation. It was fantastic to have a group of innovators sitting at your table and talking to us about the problems that they are seeing. 

Now, one of my colleagues said that he feared we would spend 

our time making up stories about how HHS and FDA kind of get 

in the way, but we don’t have to make them up. All we have to 

do is read the testimony from yesterday. 

6 

One of the things that came through regularly in their words 

was that the uncertainty that is there from the FDA, this big gray 

area in the center, that you don’t know if you are going to be regulated as a medical device. If you don’t know how far that arm of 

government is going to reach and how massive the overreach will 

be, or will it be contained and will there be some certainty? 

Now, I don’t think it is up to the FDA to provide that certainty. 

I think it is up to Congress to decide what FDA’s role should be. 

We are seeking your thoughts and the panel yesterday and tomorrow to make certain that we approach this in the appropriate manner. What we want to be certain that we do is allow the environment for innovation to take place. As Dr. Burgess said, these are 

tools that today’s doctors and future doctors are going to be able 

to use. I think 15 percent of apps are used by providers. That is 

something that will yield to cost savings. At the same time, patients are able to have a more active participation in their health 

care, from managing diseases and chronic conditions, by having access to an app that goes with them everywhere they go. 

So we look forward to hearing from you to setting the right path 

forward, and we thank you for your time. 

I yield back. 

Mr. PITTS. Chair thanks the gentlelady, and now recognizes the 

ranking member of the full committee, Mr. Waxman, for 5 minutes 

for an opening statement. 

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

Mr. WAXMAN. Thank you, Mr. Chairman. 

Today is our second day of hearings on this subject. This is the 

week that this committee decided that in three of its subcommittees, we would hold hearings to scare people that they won’t be 

able to develop what we want to see developed, innovative ways to 

communicate in the health space. The Energy and Commerce Committee has a history of bipartisan accomplishments, and even in 

this area, and that is one of the reasons, to me, why the partisan 

hyperbole we have heard from some on this topic is so disappointing. 

Yesterday, the Telecommunications Subcommittee examined mobile medical applications and the FDA regulation of medical devices. Both sides of the aisle agree we must promote innovation in 

the dynamic mobile medical applications market. Both sides agree 

that it is essential for the FDA to ensure the safety and effectiveness of potentially dangerous medical devices, even if they are also 

connected to a mobile platform. But we spent far too much of yesterday’s hearing debating an imaginary tax on smartphones, because in the Affordable Care Act, there is a tax on medical devices. 

So you have got two things to worry about. If you innovate, FDA 

might look at it and regulate it, and two, if it is a medical device, 

it may be taxed. Oh, you shouldn’t sleep anymore at might worrying about these problems Republicans are dreaming up. 

So they said FDA is going to regulate these iPhones, the same 

way it regulates heart valves. Well, that is a political talking point 

and it is just not real. I hope today we can focus on this commitVerDate Nov 24 2008 13:42 Sep 13, 2013 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-21 CHRIS
7 

tee’s real bipartisan accomplishments in health information technology. 

In the 111th Congress, the Congress before the last one, our committee passed what was called the Health Information Technology 

for Economic and Clinical Health Act as part of the Recovery Act. 

They called this the HITECH—that is the way we do it, so we got 

a new acronym. This law resulted in an explosion of electronic 

health records and other advanced health information technology— 

exactly what we wanted to see. Physicians, hospitals, pharmacies, 

health care providers across the country are building an infrastructure network as important to our Nation’s future as the interstate 

highway system. It is just like the construction of the interstates. 

Building this infrastructure is challenging. Hundreds of thousands 

of physicians, tens of thousands of hospitals, clinics, pharmacies 

are going to connect to this network and HHS is—made a lot of 

progress by engaging a wide variety of stakeholders and driving coordination without mandating a ‘‘one size fits all’’ solution. So we 

are trying to develop the ability technologically to communicate, 

and it is an ambitious goal. A seamlessly connected health information infrastructure protects privacy while demanding the highest 

quality, most efficient care. We haven’t reached that goal yet, but 

I believe we are on track to get there. 

So given our enormous progress, it would be rash and unwise to 

turn back now. This is worth doing. Similar to the health IT, our 

approach to mobile health applications has to strike the correct balance between innovation and patient safety. Well, we had a hearing yesterday where we made it clear that FDA wouldn’t take mobile apps and regulate mobile apps, even if they had information 

on general health and wellness, and even if it functioned as electronic health record system. I think it is wise. We shouldn’t regulate this in any way as a medical device. But if you had something 

on your iPhone that purports to help diagnose skin cancer or congenital heart defects, well, you got to have some appropriate regulatory scrutiny. You get a lot of false positives, you get false negatives, people are being confident in these devices, and we better 

know whether you can be confident in these devices, if they are 

going to tell you that a mole, don’t worry about it, it is not cancerous, when, in fact, it could be melanoma. 

We don’t believe in this country that buyer should beware. Well, 

my colleagues in Congress should act. Congress has acted, and in 

fact, when we had the Medical Devices User Fee Act in the last 

Congress, we specifically rejected in that bill a moratorium on 

FDA’s use of its authority over medical devices that happened to 

be implemented as mobile applications. 

My last point is even if it is regulated as a medical device, it is 

not going to be charged with a tax. That tax only goes to certain 

kinds of devices. So don’t be scared. Look at the law, look at the 

reality, and don’t listen to the political rhetoric which this week 

has been orchestrated very carefully by my Republican colleagues. 

Yield back the balance of my time. 

Mr. PITTS. Chair thanks the gentleman. 

That concludes our opening statements. We have one panel 

today. I would like to thank our distinguished panel of experts for 

providing testimony today, and I will introduce them at this time. 

8 

First, Dr. Joseph Smith, Chief Medical and Chief Science Officer, 

West Health Institute; secondly, Ms. Christine Bechtel, Vice President, National Partnership for Women and Families; third, Mr. Jim 

Bialick, Professor of Public Policy, Georgetown Public Policy Institute; fourth, Dr. Jacqueline Mitus, Senior Vice President, Clinical 

Development and Strategy, McKesson Health Solutions; and finally, Dr. David Classen, Chief Medical Information Officer, Pascal 

Metrics, Associate Professor of Medicine and Consultant in Infectious Diseases, University of Utah School of Medicine. 

Thank you all for coming this morning. You will each be given 

5 minutes to summarize your testimony. Your written testimony 

will be entered into the record. 

Dr. Smith, we will start with you. You are recognized for 5 minutes for your opening summary. 

STATEMENTS OF JOSEPH M. SMITH, M.D., Ph.D., CHIEF MEDICAL AND CHIEF SCIENCE OFFICER, WEST HEALTH INSTITUTE; CHRISTINE BECHTEL, VICE PRESIDENT, NATIONAL 

PARTNERSHIP FOR WOMEN AND FAMILIES; JIM BIALICK, 

EXECUTIVE DIRECTOR, NEWBORN COALITION; JACQUELINE 

MITUS, M.D., SENIOR VICE PRESIDENT, CLINICAL DEVELOPMENT AND STRATEGY, MCKESSON HEALTH SOLUTIONS; AND 

DAVID CLASSEN, M.D., CHIEF MEDICAL INFORMATION OFFICER, PASCAL METRICS, AND ASSOCIATE PROFESSOR OF 

MEDICINE AND CONSULTANT IN INFECTIOUS DISEASES, 

UNIVERSITY OF UTAH SCHOOL OF MEDICINE 

STATEMENT OF JOSEPH M. SMITH 

Dr. SMITH. Chairman Pitts, Ranking Member Pallone, and members of the subcommittee, thank you for the opportunity to testify 

today. I am Dr. Joseph Smith, Chief Medical and Science Officer 

for the West Health Institute, a nonpartisan, nonprofit, applied 

medical research organization dedicated to lowering the cost of 

health care for public good by research and development of innovative, patient-centered solutions. 

Our Nation’s health care system is in dire need of dramatic 

change as we lead the world in health care spending, lag many of 

our peer nations in critical health outcomes, and face into a growing aging population a tsunami of chronic disease, with a relative 

shortage of physicians, it is difficult to overstate our challenges, 

but suffice it to say that our health care delivery system is exceeding both our Nation’s budget and our provider’s bin without yet 

meeting our patient’s needs. 

We see an enormous opportunity to use information technology, 

device innovation, mobile and wireless technology, and smart and 

learning systems to both transform health care delivery and create 

empowered, informed consumers of health care. Health care must 

be allowed and encouraged to rapidly evolve using the same innovations that have already revolutionized banking, education, retail, 

computing, photography, and communication. We must take 

proactive steps to assure that those technologies that have enabled 

a revolution of decentralization, democratization, automation, and 

personalization, and other aspects of our lives and our economy 

have the same beneficial impact on health care. 

9 

To enable this transformation, three elements appear required. 

One, streamlined, predictable, transparent, risk-based regulation 

that fosters innovation and investment for the benefit of patients, 

as well as our ailing health care system; two, a proactive regulatory and reimbursement stance on true functional interoperability, not only EHR interoperability, but specifically, medical device interoperability to create an integrated, fully coordinated web 

of patient-centered health care technology; and three, reimbursement policy that aligns stakeholder incentives and drives adoption 

of appropriate technology to improve safety, efficiency, and cost of 

care. 

At this point in time, when health care is truly a ‘‘burning platform,’’ we need to stimulate innovation and experimentation. This 

requires a clear, consistent, and timely approach to regulation. 

Outside of health care, we have witnessed a revolution in information, communication, and device technology driven by innovation 

and investment, all encouraged by a predictable regulatory posture. 

Within health care, however, we have yet to fully exploit the potent 

intersection of these technologies. 

With respect to medical apps, while we have witnessed an explosion of innovation in the health and wellness applications, we have 

seen relatively little activity in the critically important, but more 

heavily regulated, areas of remote monitoring, diagnosis and treatment of those chronic diseases that burden patients, and make up 

the lion’s share of our health care spending. And for medical apps 

and clinical decision support, it is an open question of whether the 

existing medical device regulatory framework can be sufficiently 

modified to provide the applicability, clarity, predictability, and 

timeliness required. 

The FDA’s draft guidance on mobile medical apps offered some 

improved clarity, but still described significant areas of regulatory 

discretion, and now after lengthy delay without becoming finalized 

has left an industry in limbo. 

Going forward, considering the frequency with which both general app user interfaces and medical treatment guidelines used in 

clinical decisions support algorithms that are routinely updated, 

the prospect of having all such changes subject to the complex regulatory process for medical device revision seems more than 

daunting. Whatever the process, we must drive regulation at the 

pace of innovation, and not vice-versa. 

The second priority is to use regulatory and reimbursement policy to encourage true functional interoperability of information systems, and medical devices. Health care needs to exploit a truly connected and coordinated med app technology that can be seen as 

originating at the patient with those surrounding or even implanted medical devices with seamless sharing of relevant information among all such devices and the background EHR. The current 

lack of such true functional interoperability results in safety hazards and inefficiencies that we do not tolerate in other less critical 

areas, and it creates additional barriers for new innovative entrants. 

Standards-based interoperability allows the information required 

for commerce and banking and communication and education to 

move at the speed of innovation, and yet, when it comes to our 

10 

health care, information is stuck in multiple non-communicating 

silos as lifesaving devices are forced to work independently, despite 

being inches apart, all in service of the same critically ill patient. 

Today we released a study illustrating that true functional medical device interoperability not only brings improvements in patient 

safety and efficiency, but may also result in savings of more than 

$30 billion annually. Established labeling for medical device interoperability and inclusion of such stage three meaningful use could 

encourage adoption of such functional interoperability for patient 

benefit and health care savings. 

The third priority area is regulation of reimbursement policy that 

promotes aligned incentives. Reimbursement systems that disproportionately reward hospital-based procedures over office-based 

procedures, or face-to-face encounters over remote encounters need 

to give way to reimbursement based on outcome, not location, and 

value, not volume. Only in this way will we unleash the power of 

information communication and medical device technology. 

In closing, the West Health Institute believes that streamlined, 

predictable, transparent, risk-based regulation, a proactive regulatory and reimbursement stance on medical device interoperability, and realistic and actual policy to align stakeholder incentives can help to unleash a needed and long overdue transformation of our health care delivery system to allow it to 

sustainably address the needs of today’s patients and meet tomorrow’s challenges. 

Thank you very much. 

[The prepared statement of Dr. Smith follows:] 

11 


80806.001

Testimony of Joseph M. Smith, MD, PhD 

Chief Medical and Science Officer, West Health Institute 

Subcommittee on Health, Committee on Energy and Commerce, 

U.S. House of Representatives 

"Health Information Technologies: How Innovation Benefits Patients" 

March 20, 2013 

SUMMARY OF KEY POINTS: 

The West Health Institute (WHI) sees an enormous opportunity to use information technology and device 

innovation to transform health care delivery and create empowered, informed consumers of health care. 

We believe the three key enablers of this needed transformation are: 

1. Predictable, transparent risk-based regulation that fosters innovation and investment. Unclear, 

unpredictable, and/or heavy-handed regulation can have a chilling effect on the intersection of mobile 

technology, medical information, and clinical decision support. Stimulating innovation and 

experimentation requires a clear and consistent approach for when regulation enters the process and 

how far-reaching it should be. Our current regulatory environment favors large incumbents with domain 

expertise and financial resources necessary to navigate the ambiguity, complexity and, often, modified 

guidelines that unpredictably "move the goal posts." Clear, predictable, and appropriate risk-based 

regulation can unleash the disruptive innovation required to transform health care to a sustainable 

enterprise. 

2. A proactive regulatory and reimbursement stance to achieve true functional interoperability. A WHI 

analysis shows that true medical device interoperability could improve the delivery of quality patient 

care and result in more than $30 billion a year in savings. True system-wide functional interoperability 

exceeds the relatively narrow issue of electronic health records and specifically includes functional 

interoperability between medical devices to create seamless information exchange around the patient. 

In the absence of such interoperability information is confined in multiple non-communicating silos 

as lifesaving devices just inches away from one another are forced to work independently. 

3. Reimbursement policy that aligns stakeholder incentives and drives adoption of appropriate 

technology. The Health Insurance Portability and Accountability Act (HIPAA) and its implementing 

regulations were intended to protect consumers, but are sometimes applied as a reason not to share 

patient data. Patient care suffers when providers experience delays in receiving needed information. We 

must ensure that policies enable data sharing. In addition, systems that disproportionately reward faceto-face encounters over remote encounters must give way to reimbursement based on outcome and 

value - not process, location, and volume. Enabling technologies and disruptive care delivery models 

exist, however, until incentives are aligned, they will not be broadly embraced. 

1 
12 


80806.002

Testimony of Joseph M. Smith. MD. PhD 

Before the 

Suhcommittee on Health 

Committee on Energy and Commerce 

U.S. House of Representatives 

Hearing on: 

"Health Information Technologies: How Innovation Benefits Patients" 

March 20. 2013 

Chairman Pitts. Ranking Member Pallone and members of the Subcommittee. thank you for the 

opportunity to testify about the important topic of health information technology (IT). My name is 

Joseph Smith. and I am the Chief Medical and Science Officer of the West Health Institute, a non-partisan, 

non-profit, applied medical research organization. In addition to my current role, I have spent the last 28 

years at the intersection of medicine and innovative technology, practicing and teaching medicine and 

clinical cardiac electrophysiology in academic and private practice settings, as weI! as designing and 

developing novel medical device technology. 

Our nation's health care system is in dire need of dramatic change. The subtitle of the Institute of 

Medicine's (!OM) recent publication on U.S. health says it all: "Shorter Lives, Poorer Health:'1 The report 

illustrates that Americans are living sicker and dying quicker than citizens of peer nations that spend far 

less for higher quality outcomes. The economics are unsustainable. As we approach spending nearly 20 

1 Institute of Medicine of the National Academies, U.S. Health in International Perspective: Shorter Lives, Poorer Health Uanuary 

9, 2013). Available: http://www,iom edu/Reports/2013 /US~Health-in-lnternatjQnal-Perspective-ShQrter-Lives-PQQrer-

~. 

1 
13 


80806.003

percent of our gross domestic product [GDP]2 and our family budgets3 on health care, we risk foreclosing 

on the American Dream, hindering our international competitiveness, and potentially compromising our 

national security. The logistical challenges of extending our current model of care delivery to an aging 

population, with a growing shortage of physicians, only make the need for change more clear. Further 

evidence of the enormity of this challenge was provided in the recent 10M report as it described that the 

time required for a family physician to deliver gUideline-based care to one-day's patient panel requires 

an impossible 21.7 hours.4 Our health care delivery system is clearly exceeding our nation's budget and 

our providers' bandwidth. 

Faced with this crisis of cost and the unsustainability of our health care delivery system, the Gary and 

Mary West Foundation started the West Health Institute in 2009. The West Health Institute is an applied 

medical research organization dedicated to lowering the cost of health care by driving patient-centered 

solutions that make quality health care more affordable, more accessible, and more efficient. 

We see an enormous opportunity to use information technology, device innovation, and smart/learning 

systems to transform health care delivery and create empowered, informed consumers of health care. 

Health care must be allowed and encouraged to rapidly evolve using the same innovations that have 

already revolutionized other industries. Banking, education, retail, computing, photography, and 

communication have all been transformed in our lifetimes, lowering their complexity and cost while 

improving efficiency and ease of use. Health care has avoided this modernization, perSisting in a model of 

delivery that to our grandparents is as recognizable as it is complex and unaffordable. We must take 

2 Centers for Medicare & Medicaid Services, National Health Expenditure Data 2010·2011. Available: 

http://www .cms.gov /Research·Statistics~Data·and·Systems IStatistics-Trends-andReports/NationalHealthExpendData/NationalHealthAccQuntsProjected html 

:3 Commonwealth Fund, 2003 and 2010 Medical Expenditure Panel Survey --Insurance 

4 ld. Page 5-5 

2 
14 


80806.004

proactive steps to assure that the disruptive forces of decentralization, democratization, automation, and 

personalization - that have beneficially revolutionized other aspects of our lives and our economy - have 

the same beneficial impact on health care. 

This is about much more than electronic health records (EHRs). The conversation needs to be elevated to 

one of enabling the vision and promise of medical information and device technology to create 

integrated, interoperable learning systems to dramatically improve outcomes, lower costs, and create a 

higher-value health care system. Importantly, the technological elements required to realize this 

transformation in health care delivery are close at hand, but our regulatory and reimbursement systems 

frustrate the innovation, development, and adoption required to realize the full vision. 

We believe three key enablers of the needed transformation are: 

• Streamlined, predictable, transparent, risk-based regulation that fosters innovation and 

investment for the benefit of patients, as well as our ailing health care system; 

A proactive regulatory and reimbursement stance on true functional interoperability, not just the 

semantic interoperability of our electronic health records, but also medical device 

interoperability -- to take full advantage of the medical technology that we have to create an 

integrated, coordinated health care system; and 

Reimbursement policy that aligns stakeholder incentives and drives adoption of appropriate 

technology to improve the safety, efficiency, and cost of health care delivery. 

3 
15 


80806.005

The first priority addresses the essential need for innovation and the chilling effect that unclear, 

unpredictable, or heavy-handed regulation can and does have in this critically important intersection of 

mobile technology, medical information, and clinical decision support At this point in time, when health 

care is a true "burning platform," we need to stimulate innovation and experimentation. To do so, we 

need a clear and consistent approach for when regulation ent<;rs the process, as well as how far-reaching 

it should be. Outside of health care, we have witnessed a revolution in information and communication 

technology driven by innovation and investment, and a similar dramatic increase in the capability and 

economy of ubiquitous (non-medical) electronic devices, all encouraged by a predictable regulatory 

posture. Within health care, however, we have yet to fully exploit the potent intersection of these 

technologies. Even with respect to 'medical apps: the overwhelming majority of offerings are health and 

wellness applications" and the bulk of the available 97,000 mobile health apps are dedicated to medical 

providers as opposed to consumers or patients. Unfortunately, there is relatively little activity in the 

critically important - but more heavily regulated - areas of remote monitoring, diagnosis, and treatment 

of those chronic diseases that burden patients and make up the lion's share of our health care spending. 

Tele-dermatology represents an interesting case study. The lightly regulated smart phone with its 

integrated camera can be readily used to photograph a suspicious mole and transmit a picture to a 

dermatologist, and there is no additional regulatory burden encountered by its use. Yet, when this 

becomes packaged as a specific, user-friendly, documented, and downloadable app from the app store, 

purpose-built for use in tele-dermatology, it requires FDA approval. By 2017, more than 3.4 billion 

people will have smartphones or tablets with access to mobile applications: we must encourage 

innovation from all corners for use in solving our most pressing and burdensome health care needs. 

4 
16 


80806.006

We need to recognize that our current regulatory environment favors the large incumbents that already 

have the domain expertise and financial resources to navigate the ambiguity, complexity and, quite often, 

modified guidelines that unpredictably "move the goal posts." !fwe are to have any hope of 

democratizing and decentralizing health care, we need to encourage the disruptive innovation required 

to transform it to a sustainable enterprise. We need to "free" the innovation cycle with predictable and 

transparent risk-based regulation so that the full benefits of these emerging and rapidly evolving 

technologies can be realized. Specifically for medical apps and clinical decision support, it is an open 

question whether the existing medical device regulatory framework can be modified to provide sufficient 

applicability, clarity, and predictability, or whether we need to consider an alternative, less burdensome 

framework to spur innovation. Tbe FDA's draft guidance on mobile medical apps offered some improved 

clarity, but still described significant areas of "regulatory discretion," and now after lengthy delay without 

becoming finalized, has left an industry in limbo. And going forward, considering the frequency with 

which both apps and medical treatment guidelines used in clinical decision support algorithms are 

routinely updated, the prospect of having all such changes subject to the complex regulatory process for 

medical device revision seems more than daunting. As we address this, we must learn to move regulation 

at the pace of innovation and not vice-versa. 

The second priority is to use regulatory and reimbursement policy to encourage true functional 

interoperability of information systems and medical devices. We view interoperability as the ability of 

medical devices and health care systems to seamlessly communicate and exchange information to 

improve the delivery of care. This connected and coordinated net can be seen as originating at the 

patient and surrounding or even implanted medical devices, with seamless sharing of relevant 

information among all such devices and the background ERR. The current lack of such true, 

functional interoperability results in safety hazards and inefficiencies that we do not tolerate in 

5 
17 


80806.007

other, less critical settings and it creates additional barriers for new, innovative entrants. One 

need only consider the democratizing influence of the Internet communication protocols and the 

resulting deluge of innovation to understand the full impact of inter operability. And tOday, while 

all of our Internet-enabled devices freely and instantaneously share e-mail and information, the 

medical devices that surround our most acutely ill patients most often function completely blinded 

of the critically important information being collected by other such devices only inches away. 

Standards-based interoperability allows e-mail to work seamlessly across different servers, cars to 

fill-up their gas tanks at different filling stations, phone calls to be completed between different 

head-sets, and yet, when it comes to our health care, information is stuck in multiple noncommunicating silos as lifesaving devices are forced to work independently. We can do better. 

An analysis (attached) conducted by the West Health Institute, which was released to the public today, 

shows that the delivery of quality patient care could be enhanced and made dramatically more affordable 

by medical device interoperabiIity. Our analysis suggests that true functional medical device 

interoperability improves patient care, increases efficiency, and results in more than $30 billion a year in 

health care savings. 

To realize these benefits, providers, payers, medical device manufacturers, and the government will need 

to collaborate to promote the development, testing, certification, labeling, and adoption of seamlessly 

interoperable devices. Industry trends are already driving providers and payers to converge and share 

risk through care coordination, clinical integration, and improved population health management. 

Stakeholder collaboration will provide a strong platform for accelerating adoption of medical device 

interoperability and realizing its associated benefits. 

6 
18 


80806.008

The third priority area is policy that promotes aligned incentives. We are starting to see the unintended 

consequences of well-meaning policy. For example, the Health Insurance Portability and Accountability 

Act (HIPAA) and its implementing regulations were intended to protect consumers, but are complicated 

and sometimes mistakenly applied as a reason not to share patient data. Fear of HIPAA violations results 

in onerous requirements for sharing. Patient care suffers when providers experience delays in receiving 

needed information. We must ensure that policies enable requisite data sharing across traditional and 

emerging participants in the health care ecosystem. The financial services industry has developed secure 

approaches to privacy and security that, while imperfect, provide sufficient protection to enable a 

revolution in banking and retail services. Health care should learn from this example and allow the 

Internet, which changes everything, to change health care. 

Reimbursement systems that disproportionately reward hospital-based procedures over office-based 

procedures, or face-to-face encounters over remote encounters, need to give way to reimbursement 

based on outcome, not process, and value, not volume. Only in this way will we unleash the power of 

information, communication, and medical device teChnology. Enabling technologies and disruptive care 

delivery models exist; however, until incentives are aligned, they will not be broadly embraced. 

Telemedicine is one such example where the technology allows remote care, but reimbursement 

mechanisms frustrate full and best use as practitioners are often not paid for the care they can provide 

remotely, providing perverse incentives for unneeded patient travel and excessive costs of care. 

In closing, the West Health Institute believes the following are imperatives in order to reach our nation's 

health IT goals and create a model of health care delivery in service of the patient: 

7 
19 


80806.009

Streamlined, predictable, transparent, risk-based regulation; 

• A proactive regulatory and reimbursement stance on medical device interoperability; and 

Realistic and actionable policy to align stakeholder incentives. 

Thank you for your time. This is an important conversation and, on behalf of the West Health Institute, 

we look forward to advancing these imperatives for patients and our health care system. I am happy to 

answer any questions. 

8 
20 


80806.010

Selected references for the value of telemedicine, telehealth and remote monitoring: 

As early as 1997, Kaiser Permanente's Tele-Home Health Research Project demonstrated that the use of Remote 

Monitoring could provide a 33-50 percent decrease in the cost of care delivery and increased patient 

satisfaction.1 

A 2009 report produced by the Center for Technology and Aging identified that remote patient monitoring is 

among seven technologies with great potential to improve care of chronic conditions, reduce healthcare costs 

and maximize the independence of older adults 2 

Research performed by the New England Healthcare Institute (2009) demonstrates that remote patient 

monitoring has the potential to prevent between 460,000 and 627,000 heart failure-related hospital 

readmissions each year. Based on this reduction in hospitalization, NEHI estimates an annual national cost 

savings of up to $6.4 billion dollars' 

Centura's Health at home has demonstrated the ability oftelehealth to significantly reduce readmission rates for 

home care- based Medicare beneficiaries to 6 percent.' 

Building on its success with telehealth, Centrua Health at home (CHAH) recently completed a oneyear program 

to further decrease 30-day rehospitalization rates and increase quality of life among older adults by expanding 

its telehealth services. The project was funded by the Center for Technology and Aging as one of five grant 

projects in the Remote Patient Monitoring Diffusion Grants program. CHAH integrated two independent, 

successful home health service programs, a clinical call center staffed by registered nurses (RNs) and a remote 

patient monitoring (RPM) program. The year-long program reduced the frequency of 30-day rehospitalizations 

and home RN visits, while improving quality of life, self-management, and education among patients.' 

Remote phYSiological monitoring was implemented in the Veterans Health Administration (VHA) as part of a 

larger coordinated care program. The VHA sought to improve the quality of care and reduce overall spending by 

delivering the right care to the right patient at the right time, especially for patients with chronic conditions who 

are at high risk for hospitalization. VHA nurses used a Web-based application to review monitored patients' 

data. This coordinated care has resulted in decreased outpatient visits, lower hospital admissions, and fewer 

prescription medications. S In addition, 

Emergency room visits decreased 40%. 

Hospital admissions dropped 63%. 

Patients experienced a 60% reduction in bed days. 

Nursing home admissions decreased 63%. 

Patients reported a 95% satisfaction rate with the program. 

An update to this experience provided by its Director, Dr. Adam Darkins on March 15, 2013 includes 

In FY2012, VA specific Telehealth Applications (Clinical Video Telehealth, Home Telehealth and Store 

and Forward Telehealth (SFT) provided care from 150 VA Medical Centers (VAMCs) and 750 

Community Based Outpatient Clinics (CBOCs) to 497.342 patients: This amounted to 1.429.424 

telehealth episodes of care. Forty-nine percent (49%) of these patients lived in rural areas, and may 
21 


80806.011

For further reading: 

otherwise have had limited access to VA healthcare; The number of Veterans receiving care via VA's 

telehealth services is growing approximately 29% annually 

In FY2012, of the 119,535 Veterans enrolled for home telehealth services in VA, 42.699 patients 

were supported by HT to live independently in their own homes, patients who otherwise would 

have needed long-term institutional care. The current census (pOint prevalence) of home telehealth 

receiving care on March 14'" 2013 is 77,461. 

Since FY2003, VA has delivered over 800.000 patient telemental health encounters from 146 VA 

facilities to 531 VA community based outpatient clinics (CBOCs), an 18-fold increase in consultations 

over these years. 

In FY2012, VA delivered over 217.000 telemental health consultations to over 76,000 

patients, this activity took place between 146 VAMCs and 531 CBOCs. 

In FY201O, VA established a National Telemental Health Center. In FY2012, this center 

provided 1,251 video encounters to 427 unique patients at 24 sites that were in 13 states. 

The scope of VA's telemental health services includes all mental health conditions with a 

focus on post~traumatic stress disorder, depression, compensation and pension exams, 

bipolar disorder, behavioral pain and evidence-based psychotherapy. 

In FY2012, chronic disease management provided via home telehealth devices supported 

7.100 patients with chronic mental health conditions to live independently in their homes, 

so far in FY2013 VA has conducted over 3.632 video consultations with 912 Veterans directly 

into their homes. 

Remote Patient Management: Technology-Enabled Innovation And Evolving Business Models For Chronic Disease Care' 

Source: Health Affairs 

Date: 2/2009 

Remote patient management (RPM) is a transformative technology that improves chronic care management while 

reducing net spending for chronic disease. Broadly deployed within the Veterans Health Administration and in many 

small trials elsewhere, RPM has been shown to support patient self-management, shift responsibilities to non-clinical 

providers, and reduce the use of emergency department and hospital services. Because transformative technologies 

offer major opportunities to advance national goals of improved quality and efficiency in health care, it is important to 

understand their evolution, the experiences of early adopters, and the business models that may support their 

deployment. 

Remote patient management technologies are attracting new interest from organizations at risk for the consequences of 

poorly managed chronic disease care. 

THE MOST PRESSING TASK OF HEALTH CARE is to make care effective and affordable; this is particularly important in the 

case of chronic disease. In this paper we examine current and emerging business models in health care that use new 

technologies for the remote management of chronic care, and early evidence that these technologies may enable new 

levels of efficiency and patient self-management. 

Systematic Review of Home Telemonitoring for Chronic Diseases: The Evidence Base' 

Source: JAMIA 

Date: 2007 

Highly cited review article by Pare et al. 
22 


80806.012

Public Policy Implications for Using Remote Monitoring Technology to Treat Diabetes5 

Source: Journal of Diabetes Science & Technology 

Date: 5/2007 

Key abstract: 

Since the late 1990s, numerous studies have addressed the efficacy of remotely monitoring patients with the major 

chronic diseases and tested the feasibility of employing the Internet as a new communications tool in the 

physician/patient relationship. Vitally important questions have been asked and answered successfully by careful, 

thoughtful, and thorough investigators. Studies consistently reveal that when used to help monitor glucose levels, RPM 

lowers Ale levels, improves overall outcomes, and saves everyone time and money.1-12. 

An independent analysis of remotely monitored and nonmonitored patientslJi found that remote monitoring reduced 

hospitalization and emergency care Visits and improved patients' functional status. For diabetes care, the average 

improvement/stabilization rate in activities of daily living for patients using remote monitoring was 77.2% vs 70.4% for 

those patients not using remote monitoring. The New England Healthcare Institutell studied RPM in cardiac patients and 

found that RPM delivers value over standard care methods by reducing patient rehospitalization rates by 32%, resulting 

in a total reduction of 132 patient days per 100 patients, producing a net cost savings of 25% and yielding savings of 

$1861 per patient over a 6-month postdischarge period. 

Home Monitoring for Heart Failure Management8 

Source:NIH 

Date: 1/10/2012 

Key abstract: 

Two recent meta-analyses have suggested that telemonitoring in ambulatory HF patients can improve mortality by 17 to 

47% during six to twelve months of follow-up and reduce hospitalizations by 7 to 48% 1.6.0.£1). 

The difficulty in managing HF is manifest not only by a high rate of HF hospitalizations, currently estimated at 

approximately 1 million annually in the United States (US) (~), but also by a 30-day readmission rate of 27%, the highest 

among all medical conditions neceSSitating hospitalization (1). Acute in-hospital care is responsible for up to 70% of the 

annual cost of HF in the US and other developed countries C5J Given the aging population and growing economic 

burden, improved management of the HF patient at home and prevention of hospital admissions have become national 

priorities. Rehospitalization rates for HF are now the target of publicly reported performance measures, national 

improvement initiatives, and government incentives (§) 

References: 

1. Johnston B, Wheeler L, Deuser J, Sousa K. Outcomes of the Kaiser Permanente Tele-Home Health Research 

Project. Archives Of Family Medicine [serial on the InternetJ. (2000, Jan), [cited March 15, 2013J; 9(1): 40-45. 

Available from: http://smartlivinggzt.files.wordpress.com/2011/02/wetenschappeliik-artikel-over-telehome-care.pdf 

2. Center for Technology and Aging. Technologies to Help Older Adults Maintain Independence: Advancing 

Technology Adoption. [serial on the InternetJ. 2009 [cited 2013 Mar 14J. Available from: 

http://www.techandaging.org/briefingpaper.pdf 

3. New England Healthcare Institute. Research Update Remote Physiological Monitoring. [serial on the 

InternetJ. 2009 [cited 2013 Mar 14J. Available from: 

http://www.nehi.net/publicationsf36/remote physiological monitoring research update 
23 


80806.013

4. Broderick A, Steinmetz V. Centura Health at Home: Home Telehealth as the Standard of Care. [serial on the 

Internet]. 2013 [cited 2013 Mar 14]. Available from: 

http://www.commonwealthfund.org/-/media/Files/Publications/Case%20Study/2013/Jan/1655 Broderick 

telehealth adoption Centura case study. pdf 

5. Ubi s. Public policy implications for using remote monitoring technology to treat diabetes. Journal Of 

Diabetes Science And Technology [serial on the Internet]. (2007, May), [cited March 15, 2013]; 1(3): 436-

439. Available from: http://www.ncbi.nlm.nih.gov/pmc/articies/PMC27695 

6. Coye M, Haselkorn A, DeMello S. Remote patient management: technology-enabled innovation and evolving 

business models for chronic disease care. Health Affairs (Project Hope) [serial on the Internet]. (2009, Jan), 

[cited March 15, 2013]; 28(1): 126-135. Available from: http://content.healthaffairs.org/content/28/1I126 

7. Pare G, Sicotte C, St-Jules D, Gauthier R. Cost-minimization analysis of a telehomecare program for patients 

with chronic obstructive pulmonary disease. Telemedicine Journal And E-Health: The Official Journal OlThe 

American Telemedicine Association [serial on the Internet]. (2006, Apr), [cited March 15, 2013]; 12(2): 114-

121. Available from: http://171.67.114.118/content/14/3/269.full 

8. Bui A, Fonarow G. Home monitoring for heart failure management. Journal Of The American College Of 

Cardiology [serial on the Internet]. (2012, Jan 10), [cited March 15, 2013]; 59(2): 97-104. Available from: 

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3254025/ 
24 


80806.052

The Value of Medical Device 

Interoperability 

Improving patient care with more than $30 

billion in annual health care savings 

West Health Institute 

March 2013 

Copyright ©2013 Gary and Mary West Health Institute 
25 


80806.053

About West Health Institute 

The West Health Institute is an independent, non-profit 501(c)(3) medical research organization whose 

mission is to lower health care costs by developing innovative patient-centered solutions that deliver the right 

care at the right place at the right time. This is accomplished by conducting innovative medical research, 

educating key stakeholders and advocating on behalf of patients. Solely funded by pioneering philanthropists 

Gary and Mary West, the Institute is part of West Health, an initiative combining four separate organizationsthe West Health Institute, the West Health Policy Center, the West Health Investment Fund, and the West 

Health Incubator. The Institute is located in San Diego, California, the global center for health care innovation. 

For more information, find us at westhealth.org and follow us @westhealth. 

Acknowledgements 

The Medical Device Interoperability Coordinating Council (MDICC) is an open forum to allow collaboration 

between stakeholders that are actively engaged in aspects of promoting or creating interoperable medical 

device systems. The MDICC formed in March 2012 to advance wide adoption of medical devices that 

seamlessly interoperate with other medical devices and information systems with the goal of enabling 

improved patient care. This analysis was prompted, in part, by MDICC's efforts, which validated the need to 

better quantify the value of medical device interoperability. Several individuals within MDICC deserve thanks 

for their contributions to this work. 

The Value of Medical Device Interoperability 

West Health Institute 
26 


80806.054

Table of Contents 

Abstract 

Introduction 

Methodology 

Summary of Results 

Detailed Findings 

Conclusion 

Call to Action 

Appendix: Detailed Calculations 

The Value of Medical Device Interoperability 

West Health Institute 

4 

5 

8 

11 

13 

25 

27 

31 
27 


80806.055

Abstract 

unsustainable and ever-escalating U.s. health care costs, an estimated $700 billion in wasteful spending and 

the emerging centricity of medical information and its seamless availability in the search for solutions prompt 

investigation into the value of creating functional medical device interoperability - the ability for medical 

devices to exchange information with each other and with patient data repositories such as electronic health 

records. This report examines areas of waste in health care that can potentially be eliminated through greater 

medical device interoperability and the adoption of commonly accepted standards for interoperability. Waste 

reduction through greater medical device interoperability would lead to increased efficiency, improved quality 

and more affordable care. Commonly adopted standards can accelerate the move towards greater medical 

device interoperability and potentially reduce the cost of achieving interoperability. With all of the caveats 

associated with estimating the value of a process improvement not yet deployed, our combined top-down 

and bottom-up modeling suggests that annual savings in excess of $30 billion may be liberated by widespread 

adoption of functional interoperability for medical devices. To realize the benefits, providers, payers, medical 

device manufacturers and the government will need to collaborate and partner to promote the development 

and adoption of seamlessly interoperable devices. Industry trends are already driving providers and payers to 

converge and share risk through care coordination, clinical integration and improved population health 

management. Stakeholder collaboration is expected to provide a strong platform for accelerating adoption of 

medical device interoperability and realizing its associated benefits. 

The Value of Medical Oevice Interoperability 

West Health Institute 4 
28 


80806.056

Introduction 

Overview 

Health care costs continue to consume an ever increasing proportion of U.S. spending, significantly 

outpacing the growth of our economy for each of the last four decades, and recently reaching as high as 18 

percent of Gross Domestic Product (GOP).' 

While both the absolute level of spending and its disproportionate growth are unsustainable, evidence 

indicates that as much as a third of this spending is waste (i.e., does not contribute to quality outcomes). 

According to recent estimates, more than $700 billion of the $2.4 trillion in health care spending could 

otherwise be avoided through improvements to the health care systeml Waste takes many forms, including 

inefficiency, unnecessary services and missed prevention opportunities and is believed to be broadly 

distributed across the spectrum of health care delivery. 

This study examines the sources of waste in health care that could be eliminated with medical device 

interoperability, as well as the waste resulting from a lack of commonly adopted interoperability standards. 

The report's findings suggest that increased medical device interoperability would reduce waste, lead to 

improvements in quality and decrease the cost of care. Additionally, comprehensive adoption of 

interoperability standards has the potential to reduce waste related to developing and implementing 

interoperability and facilitate increased interoperability. 

Health IT, Medical Devices and Interoperability 

Despite a nationwide push for adoption of information 

technology throughout the health care system and the 

concurrent significant advances in the technologies 

underlying medical devices, numerous barriers continue to 

impede the realization of health information technology's 

potential. A lack of functional medical device 

interoperability is one of the most significant limitations. 

Medical device interoperability refers to information 

sharing from one device to another or between devices and 

Electronic Health Records (EHRs). Functional 

interoperability would enable clinical medical devices to 

communicate in a consistent, predictable and reliable way. 

By allowing for the exchange of data with other medical 

The Value of Medical Device Interoperability 

West Health Institute 

Waste: Any activity that does not add value 

to the health care system. 

Functional Medical Device Interoperobility: 

the ability for clinical medical devices to 

communicate in a conSistent, predictable 

and reliable way, allowing for the exchange 

of, and interaction with, data from other 

medical devices and with patient data 

sources and repositories, such as electronic 

health records (EHRs), in order to enhance 

device and system functionality. 

5 
29 


80806.057

devices and with patient data sources and repositories, such as EHRs, medical device interoperability would 

enhance the function of the systems and devices. Exchange of data between EHRs is commonly designated as 

Healthcare Information Exchange (HIE) and has been analyzed in great detail elsewhere.' The reliable and 

seamless transfer of information through medical device interoperability can facilitate a number of 

improvements in efficiency and safety that can be quantified in billions of dollars of savings to the health care 

system, yet, despite these significant benefits, medical device interoperability is limited today. 

The Current State of Medical Device Interoperability and Interoperability Standards 

According to a recent report by HIMSS Analytics: while over 90 percent of the hospitals surveyed by HIMSS 

use six or more types of devices that could be integrated with EHRs (such as defibrillators, 

electrocardiographs, vital signs monitors, ventilators and infusion pumps) only a third of hospitals actually 

integrate medical devices with EHRs today. Additionally, those that are investing in interoperability integrate 

fewer than three types of devices on average, a far cry from the six to twelve devices that may be present 

around an intensive care unit (leU) bed. This lack of interoperability creates significant sources of waste and 

risk to patient safety because of incomplete or stale information clinicians must rely on for workflow and 

decision making. 

Part of the reason for limited interoperability is the high cost and complexity of medical device integration, 

which results from the lack of incentives for medical device and HIT companies to use open interfaces to 

establish interchangeable interoperability. In contrast to the "plug and play" world of consumer electronics, 

where consumer demand for simple and seamless functionality has driven convergence on a few common 

standardized interfaces and platforms, providers have not required a consistent means for achieving 

interoperability. As a result, there is a Wide range of methods used by device vendors today. Some vendors 

use distinct proprietary and closed communication methods even among their own devices. Additionally, 

some standards are loosely specified, with a number of options for configuration, meaning that even devices 

that use similar standards may not be able to communicate without further customization. As a result, 

facilitating the exchange of data between and among medical devices and EHRs currently requires hospitals to 

invest significant resources in developing custom interfaces and paying for middleware solutions. The cost of 

medical device integration has been estimated at as much as $6,500 to $10,000 per bed in one-time costs, 

plus as much as 15 percent in annual maintenance fees.4 These investments are a substantial undertaking for 

hospital systems when compared against already squeezed operating margins of less than three percent on 

revenue of approximately $700,000 per bed (based on average length and cost of inpatient stays).'" 

Within the current system, the medical device industry lacks the imperative to offer interoperability among 

devices because providers who are integrating bearthese costs and do not require medical device companies 

to follow specific standards. Many providers continue to work without interoperability since the value 

proposition has not been adequately quantified to drive prioritization of the investments necessary to achieve 

integration over competing technology or other needs. While middleware software providers and systems 

integrators have issued white papers illustrating the impact of medical device integration at a hospitallevel,7 

there have been no studies to date attempting to quantify the value of medical device interoperability in 

The Value of Medical Device Interoperability 

West Health Institute 6 
30 


80806.058

addressing waste across the health care system as a whole. There has also been no detailed examination of 

the waste generated by the lack of commonly adopted standards. Given the efficiencies and quality assurance 

tools medical device interoperability offers, this report provides health care stakeholders a clear and 

compelling case to invest in medical device interoperability. 

This paper examines the benefits of medical device interoperability in terms of the reduction of waste in 

health care. It also estimates the costs that could potentially be eliminated in a world where medical devices 

are connected in a standardized manner as computer and communications devices do today. 

The Value of Medical Device Interoperability 

West Health Institute 7 
31 


80806.059

Methodology 

This report limited the scope of its analysis to interoperability between clinical medical devices and patient 

data repositories such as EHRs and device-to-device interoperability. It included only those clinical devices 

that are potentially interoperable today, encompassing bedside monitoring devices (e.g., ECGs and physiologic 

monitors), imaging devices, diagnostic devices, surgical devices and therapeutic devices (e.g., infusion pumps). 

It focused on acute care (encompassing emergency room and inpatient settings) and did not examine the 

benefits of interoperability between EHRs in different health care organizations since HIEs constitute a distinct 

type of interoperability and have been analyzed in detail elsewhere. 2 Finally, while it is appreciated that the 

lack of functional interoperability among consumer medical devices (e.g. glucometers, weight scales and 

blood pressure monitors) outside the hospital and between such devices and more central EHRs is a related 

significant and growing challenge with its own attendant waste, the lack of conformity around the magnitude 

and growth of this aspect of the issue precluded it being included in this analysis, making the results of this 

work a more conservative estimate of the overall impact of true, functional interoperability. 

This analysis followed a three-stage process: 

1. Identification of relevant sources of health care waste. Relying on the lean Six Sigma methodology as a 

lens to define waste as "all activity that does not add value to the health care system," the perspective of 

each stakeholder within the ecosystem was examined to identify areas where waste could potentially be 

addressed and eliminated through interoperability.8lnterviews with more than 30 stakeholders from 

across the health care ecosystem (including providers, payers, medical device manufacturers and health IT 

vendors), along with secondary research, led to identifying ten areas of waste that fell into two categories: 

those arising from the lack of interoperability and those arising from a lack of commonly adopted 

standards. Of these, some were determined to be primary sources of waste for which the impact of 

interoperability could be readily quantified, and others were identified as longer-term savings 

opportunities that were indirect (i.e., would require several additional enabling factors to address) or 

were difficult to measure and therefore not specifically quantified in this report. (Figure 1) 

The Value of Medical Device Interoperability 

West Health Institute 8 
32 


80806.060

Figure 1: Areas of Waste Identified 

1. Adverse events from drug errors/ misdiagnosis, and failure to 

prevent harm 

2. Redundant testing resu!tingfrom inaccessible information 

3. Clinician time spent manually entering information 

information transfer 

5. Device testing and development costs 

6. Provider costs to integrate devices with EHRs 

7. Limited ability to coUect and leverage data analytics to improve 

clinical decision support 

8. Sub-optimal care driven by limited adoption and efficacy of remote 

patient monitoring (RPM) 

for operational maintenance and optimization of ./ 

10, limited device choice, innovation, and competition due to 

./ 

./ 

2. Definition and quantification of the addressable buckets af waste. For each segment of waste, a reference 

market was established to set a maximum value of spending that could be impacted by interoperability. 

For example, the analysis of savings related to "Time wasted manually entering information" first 

quantified the total value of nurses' time nation-wide as a maximum, and then identified the portion of 

that time spent manually documenting information and programming devices. 

3. Definition and quantification of the share of costs addressable by interaperobility. The potential impact of 

interoperable vs. non-interoperable devices was defined based on available clinical literature. Continuing 

the example of "Time wasted manually entering information," this analysis looked at the impact of 

medical device integration on documentation and programming time in published case studies to 

The Value of Medical Device Interoperability 

West Health Institute 
33 


80806.061

estimate the reduction in waste. Where an exact case study of medical device interoperability was not 

available, a surrogate analysis was selected based on its relationship to the activities interoperability 

would address. For example, "Increased length of stay from delays in information transfer," used the 

impact of another intervention that decreased test turnaround time-point of care testing- to estimate the 

impact of medical device interoperability on emergency department (ED) length of stay. 

The Value of Medical Device Interoperability 

West Health Institute 10 
34 


80806.062

Summary of Results 

The analysis identified an estimated $36 billion in potential annual, addressable waste across segments of 

health care waste in the u.s. (Figure 2). The bulk of this waste (97percent) relates to the lack of 

interoperability itself, with the remainder coming from the lack of commonly implemented standards. While a 

lack of commonly adopted standards for medical device interoperability may result in a small amount of direct 

savings, it has the ability to facilitate a more rapid adoption of interoperability, which can achieve the benefits 

described below. 

The benefits from interoperability arise from four primary activities: 1) quality improvement through 

reduction of adverse events due to safety interlocks ($2 billion), 2) reduced cost of care secondary to 

avoidance of redundant testing ($3 billion), 3) increased clinician productivity secondary to decreased time 

spent manually entering information ($12 billion) and 4) improvements in patient throughput secondary to 

shortening length of stay ($18 billion). Benefits from common adoption of standards include reduced costs for 

medical device development and systems integration within a health system. 

Figure 2: Estimated Addressable Waste 

Estimated Waste from tack of Medical Device InteroperabiHty i$M} 

$40,000 

$30,000 

$20,000 

$10,000 

$0 

$2,000 

Adverseeventsavoidable 

wlthmteroperabiHty 

$3,000 

$12,300 

Time spent manually 

entering information 

Estimated Waste from lack of Commonly Adopted Standards (SM) 

$10,000 

$0 

$430 

Device development and testing 

costs 

Note: Numbers rounded for clarity 

The Value of Medical Device Interoperability 

West Health Institute 

$740 

Provider costs to integrate 

devices with EHRs 

$17,800 $35,100 

TOTAL 

transfer 

TOTAL 

11 
35 


80806.063

For waste due to lack of medical device interoperability, the majority of benefits (93 percent) accrue to 

providers, followed by payers (6 percent), with initially de minimis direct economic benefit to patients. 

Additionally, device manufacturers and health IT companies are expected to gain little from medical device 

interoperability (Figure 3). It is important to note that differences in reimbursement policies make it difficult 

to precisely allocate the magnitude of benefits to each stakeholder; therefore the allocation provided below 

represents a reasonable estimation and allocation of those benefits. Furthermore, as patients are being asked 

to bear greater responsibility for the entirety of their medical costs, the savings initially attributed to providers 

and payors will necessarily decrease overall costs with likely proportional patient savings. 

Figure 3: Savings by Stakeholder from Increased Medical Device Interoperability 

1. Adverse events avoidable with medical device interoperability 

2. Redundanttesting resulting from inaccessible information 

3. Clinician Time Spent Manually Entering Information 

4. Increased length of stay from delays in information transfer 

Total Savings ISM) 

Total Savings (%) 

Note: Numbers rounded jor ciarity 

Providers Payers 

$1,000 $850 

$1,500 $1,275 

$12,300 

$17,800 

$32,600 $2,125 

93% 6% 

Patients 

$150 

$225 

$375 

1% 

Device 

Vendors 

$0 

0% 

For waste related to the lack of commonly adopted standards, the allocation of costs that could be 

eliminated was based upon interviews of stakeholders, whose views varied significantly, and was therefore a 

reasonable estimate based upon various expert opinions about how those costs are borne today (Figure 4). 

Figure 4: Maximum Potential Savings by Stakeholder due to lack of Commonly Adopted Standards 

5. Device testing and development costs 

devices with EHRs 

b Note: Numbers rounded jor clarity 

The Value of Medical Device Interoperability 

West Health Institute 

Providers Payers Patients Device 

Vendors 

$430 

12 
36 


80806.064

Detailed Findings 

Note: please see the appendix for detailed calculations for each area of waste. 

lack of Medical Device Interoperability 

1. Costs Resulting from Avoidable Adverse Events: $2 billion 

Medical errors result in as many as three million 

preventable adverse events each year, driving as much 

as $17 billion in excess annual medical costs and as 

many as 98,000 deaths per year:.10 Several of the most 

common causes of medical errors can be substantially 

addressed by improved medical device interoperability, 

including drug errors (accounting for 20 percent of 

adverse events), diagnostic errors (17 percent) and 

failure to prevent injury (12 percent):,lO Errors in 

technique, accounting for 44 percent, are assumed to 

be largely unaddressable by improved interoperability.1O 

Drug errors 

With and without Medical Device Interoperobility 

Medication errors can stem from errors in drug 

ordering by the physician, order transcription by various 

clinicians, drug dispensing by the pharmacist and drug 

administration at the point of care (Figure 5). 

Figure 5: Case Study: Drug Errors 

Current State: A cancer patient's pain is managed 

with patient-controlled analgesia (PCA) and has a 

physician order for a relatively low constant infusion 

rate 01 analgesia, with an intermittently high rate 

available when requested by the patient. As the 

infusion pump is being programmed, these two 

rates are reversed, resulting in over-sedation and 

respiratory depression. The patient's monitor 

demonstrates dropping pulse oximetry, but clinical 

intervention is delayed until the nurse walks back 

into room, resulting in anoxic brain injury. 

Future State: II the PCA pump were able to 

communicate with computerized physician order 

entry, transcription and administrative errors could 

be avoided. lIthe physiological monitoring device 

communicated with the pump, drug administration 

would automatically be discontinued when 

physiological parameters move outside a 

predetermined range. 

Medical device interoperability will facilitate the push of test results and vital signs readings to clinicians 

or pharmacists and automate the integration of relevant information to inform ordering decisions, thus 

avoiding ordering errors stemming from lack of patient information or inadequate monitoring. Interoperability 

can address transcription and administrative errors by allowing EHRs, physiological monitoring devices and 

medication administration devices to communicate in a seamless manner. Automation of these activities and 

functions with medical device interoperability can 1) enable automatic population of drug orders into the 

devices that administer these drugs, 2) transfer alerts and parameters for drug delivery from an EHR into the 

device and 3) provide a physiological data feed into the device. Anyone of these interventions can reduce 

drug-related adverse events. For example, the integration of intelligent infusion devices, bar-code-assisted 

medication administration and electronic medication administration records has been found to reduce errors 

further than using these systems in a siloed manner, as it enables the automatic population of providerordered, pharmacist-validated infusion variables directly into the infusion device, which verifies the dose and 

The Value of Medical Device Interoperability 

West Health Institute 13 
37 


80806.065

rate against dosing limits defined in the drug library. (Medical device interoperability would not address any 

pharmacy dispensing errors beyond those that stem from errors in transcription or ordering.) 

Calculations 

According to a study in Health Affairs, adverse drug events result in an estimated $3.8 billion in 

incremental medical costs annually: Ordering errors account for 39 percent of all drug errors." There are few 

studies specifically examining the impact of interoperability on ordering errors, but a relevant proxy is the 

impact of closed-loop e-prescribing, automated dispensing, bar-code and eMAR systems, as such closed-loop 

systems achieve their benefits by integrating the flow of information among the subsystems which comprise 

them. A study in Quality & Safety in Healthcare found that such a closed-loop system reduced prescribing 

errors by 47 percent." 

Transcription errors account for 12 percent of all drug errors;"t hese errors can be addressed for all types 

of dosage forms, as interoperability between automated dispensing devices and computerized physician order 

entry (CPOE) systems can address errors for intravenous and non-intravenous drugs alike. There are few 

studies on the impact of interoperability between automated dispensing machines and CPOE systems 

specifically, but the impact of integrating bar-code medication verification with an electronic medication 

administration system can be used as a proxy, as the latter reduces transcription errors through a similar 

mechanism: by importing orders electronically from the physician's order entry or pharmacy system. Studies 

have found that this reduces between 5013 to 100 percent" of transcription errors, so an average value of 75 

percent is used. 

Administration errors account for 38 percent of all drug errors." Because the mechanism for error 

reduction is specific to Intravenous (IV) interoperability, the proportion of addressable errors is limited to the 

60 percent that are due to intravenously administered medications.l4 A study in the American Journal of 

Health-System Pharmacy found that IV interoperability resulted in a 32 percent reduction in reported monthly 

errors involving IV administration of heparin,15 which was used as a proxy for the impact of interoperability on 

intravenously administered drug errors as a whole, given that the mechanism by which interoperability 

addresses such errors is not specific to any particular drug. 

Based on these assumptions, potential drug error-related savings from medical device interoperability 

were estimated at more than $1.3 billion annually, or 8 percent of the $17 billion total cost of preventable 

adverse events. 

The Value of Medical Device Interoperability 

West Health Institute 14 
38 


80806.066

Diagnostic errors 

With and without Medical Device Interoperobility 

Diagnostic errors result from a variety of root 

causes, such as a failure to account for symptoms, order 

appropriate tests and consider all relevant diagnoses. 

Medical device interoperability can reduce such errors 

by making symptom readings available in real time and 

pushing test results to a care provider in a timely and 

clear manner (Figure 6). 

Calculations 

Joanne Callen and colleagues found that 16.5 

percent of missed Emergency Department (ED) 

diagnoses that harmed patients were due to a 

breakdown at the step of transmitting test results to the 

prOVider." This was applied here as a proxy for the 

improvement that could be realized by medical device 

interoperability facilitating the immediate "push" of test 

results to the EHR so that the care provider has the right 

information to make appropriate diagnoses. 

Figure 6: Case Study: Missed Diagnoses 

Current State: A 35 year-old male presents to the 

Emergency Department with weakness. A nurse 

notes an abnormal heart rhythm based on bedside 

monitoring. The printed heart rhythm strip is 

reviewed by an ER physician, who admits the patient 

for observation and cardiology consultation. The 

next day, a cardiologist sees the patient, but the 

diagnostic rhythm strip in unavailable. Repeated 

ECGs are nonMdiagnostic. Additional testing is 

undertaken to reproduce the arrhythmia, all without 

effect. The patient is discharged without 

intervention and returns in 72 hours with worsening 

symptoms. 

Future state: Automated push of Information to the 

EHR would save an electronic version of heart 

rhythm monitoring results and present it to the 

cardiologist at the appropriate time, enabling the 

correct diagnosis and treatment. 

Based on this assumption, as well as the aforementioned estimates for the costs of preventable adverse 

events ($16.6 billion) and the percentage due to diagnostic errors (17 percent), it was estimated that 

Interoperabillty could result in nearly $466 million in annual savings related to addressing diagnostic errors, 

about 3 percent of the total cost of preventable adverse events. 

Failure to prevent injury 

With and Without Medical Device Interoperability 

"Failure to prevent Injury" encompasses a variety of potentially preventable conditions. A primary 

example is ventilator-associated pneumonia; interoperabillty can reduce its incidence by automating and 

facilitating the monitoring of physiological parameters and matching the ventilator support needed by 

Individual patients (Figure 7). This is particularly important for managing ICU patients with dynamic vital signs 

and lung capacity in accordance with best practice guidelines. Interoperability supports clinicians in 

performing frequent "ready-to-wean" assessments, which leads to fewer ventilator days and thus fewer cases 

of pneumonia. 

Postoperative shock can also be addressed by improved interoperability, as integrating continuous vital 

signs monitoring with alarm systems has been shown to reduce its incidence by allowing earlier intervention 

in patients whose condition is deteriorating. 

The Value of Medical Device Interoperability 

West Health Institute 15 
39 


80806.067

Calculatians 

A study in Quality & Safety in Health Care found 

that the incidence of ventilator-associated pneumonia 

decreased by 57 percent in response to a bundle of 

interventions, which included the examination of a 

number of "trigger tools" to initiate a search for root 

causes" Based on insights from industry experts who 

have studied patient safety and device interoperability, 

interoperability was conservatively assumed to 

contribute about 25 percent of the value of these 

interventions. Applying this to the approximately $1.1 

billion in health care costs from ventilator-associated 

pneumonia" would result in total potential savings of 

more than $163 million. 

A study in Anesthesiology found that continuous 

pulse-oximetry surveillance reduced "rescue events" 

(events necessitating the activation of code blue, STAT 

airway, or HERT teams) by 65 percent.i9 The study 

indicates that having timely access to information about 

changes in a patient's clinical status allows providers to 

intervene and prevent medical injury. A similar rationale 

Figure 7: Case Study: Failure to Prevent Injury 

Current State: A patient is intubated and on a 

ventilator in the leu for brain injury. The physician 

orders a ventilator setting with specific physiological 

parameters per evidence-based guidelines. Repeat 

blood gas testing is ordered to maintain these 

specific parameters. The nurse notifies a respiratory 

therapist, who draws blood and sends it to the lab. 

The nurse receives results and calls the physician 

with findings, which requires a change in the 

ventilator settings. This cycle occurs four to six times 

a day based on the patient's dynamic clinical status. 

Future State: If blood gas measurements were 

integrated in real time into ventilator settings to 

maximize gas exchange, device interoperability 

could eliminate unnecessary steps and potential 

delays, minimizing time on a ventilator and thus 

reducing the duration of hypoxia, the impact of acidbase disturbances and the risk of ventilatorassociated pneumonia. 

can be applied to the prevention of postoperative shock through the increased accessibility of information 

created by medical device interoperability. Currently, more than $35 million is spent in excess medical costs 

due to postoperative shock annually." A predictable reduction of 65 percent in postoperative shock cases was 

implied through improved medical device interoperability, resulting in potential savings of almost $23 million. 

Together, the impact of interoperability on ventilator-associated pneumonia and postoperative shock 

totals $186 million, or about 1 percent of the total $17 billion cost of preventable adverse events. 

In total, with nearly $1.3 billion in savings related to adverse drug events, $466 million related to 

diagnostic errors and $186 million related to failure to prevent injury, the analysis suggests that medical 

device interoperability could save more than $2 billion in medical costs across all preventable adverse 

events, or more than 11 percent of the $17 billion cost of all preventable adverse events. 

Additionol Foctors to Consider 

The estimated $2 billion total savings is a conservative estimate focused only on reportedly preventable 

adverse events. Preventable adverse events, defined as adverse events resulting from medical errors,'o make 

up $17 billion in costs. There is reason to believe that some proportion of adverse events typically deemed 

unpreventable today could be prevented through greater medical device interoperability, as discussed above, 

such as timely and contextual data display and smart alarms. This could move care past current best practices. 

(Reliable estimates of the percentage of un preventable errors that could be addressed by interoperability are 

not currently available, so they were not included in the estimates for this paper.) Studies also suggest that 

The Value of Medical Device Interoperability 

West Health Institute 16 
40 


80806.068

adverse events may be susceptible to underreporting. For example, a recent study in Health Affairs even 

found that common methods of adverse event detection miss 90 percent of adverse events, suggesting the 

incidence could be as much as ten times higher than reported.21 

While interoperability can further reduce adverse events in the aforementioned ways, it also poses the 

risk that, in certain instances, an interoperable system could result in magnified systemic errors. For instance, 

an incorrect drug formulation in a clinically integrated IV system could automatically push to all related 

infusion pumps hospital-wide, though this would be mitigated by the ability to centrally identify and rapidly 

respond to and correct such errors. However, this risk is a primary reason any device-to-device interactions or 

device controls based on information from another system will need to be carefully analyzed to ensure safety 

and effectiveness. 

2. Costs Resulting from Redundant Testing: $3 billion 

Redundant laboratory and radiology testing account 

for more than $8 billion in direct health care costs per 

year, according to a study in Health Affairs: 

With and without Medical Device Interoperability 

Redundant testing stems from numerous factors, 

including "defensive medicine" driven by lack of trust in 

tests conducted in other institutions and fear of liability, 

but it is often simply the result of misplaced, delayed or 

illegible hard-copy test results (Figure 8). 

Greater interoperability would allow test results to 

flow directly into an EHR, eliminating the problem of 

misplaced or illegible results. Redundant tests due to 

liability or other hospital policy-related justifications 

would not be impacted. 

Calculations 

According to a study in Quality & Safety in 

Healthcare, errors in reporting results to the physician 

and charting or filing errors made up an estimated 39 

Figure 8: Case Study: Redundant Testing 

Current State: A SO-year-old has all preadmission 

testing completed prior to surgery in an associated 

outpatient center. Results are faxed to the preadmission testing unit and a copy is given to the 

patient. The patient loses the paperwork, and the 

fax never arrives, so the patient must have all labs 

and ECG repeated on the day of surgery. The ECG is 

abnormal, without the previous version for 

comparison. The surgery is delayed and finally 

cancelled for cardiology evaluation of the 

abnormality. 

Future State: If lab testing devices populated the 

EHR directly, information would not be lost. This 

would avoid repeat testing as well as surgical case 

cancellation by providing the previous ECG for 

comparison, allowing the provider to evaluate 

existing versus new abnormalities. 

percent of testing process errors." This was used as a proxy for the share of redundant tests, which could 

potentially be attributed to lost or illegible information (as opposed to hospital policy, potential liability or 

other reasons). Assuming 95 percent these issues could be resolved with improved medical device 

interoperability that allows for pushing data to the EHR and potentially to physicians (using picture archiving 

and communication systems (PACS) as a proxy, as it provides interoperable digital storage and transmission of 

medical images and is measured as high as 99 percent effective),"·24 medical device interoperability could 

create savings of $3 billion annually, related to avoiding redundant tests from lost information-37 percent of 

the total costs of redundant testing. 

The Value of Medical Device Interoperability 

West Health Institute 17 
41 


80806.069

3. Costs Resulting from Clinician Time Spent Manually Entering Information: $12.4 billion 

Nurse time is a valuable and scarce resource, with nurse salaries accounting for an estimated $173 billion 

in health care spending per year, 25 and various studies predict a future nursing shortage, resulting from the 

aging and retiring nurse population and the increasing health care needs of aging baby boomers.26 Through 

seamless communication between devices and EHRs, interoperability can reduce the manual verification and 

documentation activities nurses must currently perform and allow them to use their time more effectively 

caring for patients. 

With and Without Medical Device Interoperability 

Studies estimate that about 35 percent of a nurse's shift time is spent on documentation.'7 A significant 

proportion of this time is spent simply manually entering vital signs readings onto paper charts or into EHRs. 

Interoperability eliminates this time by automatically sending readings from devices to EHRs. 

Another source of inefficiency is time spent manually programming devices (e.g., infusion pumps), which 

is a complex, cumbersome process today. Interoperability significantly reduces this time by enabling the 

automatic population of prOVider-ordered and pharmacist-validated infusion variables directly into the 

infusion device. 

Ca/culations 

With regards to manually entering vital signs readings, studies on the impact of medical device 

integration find that it eliminates a significant proportion of documentation time. The literature relied on for 

this analysis suggested a conservative 20 percent reduction in documentation time.'· When extended across 

the 1,612,000 registered nurses in U.S. hospitals, '9 paid an average of $106,500 a year,'O,31 this would amount 

to more than $12 billion in annual savings. 

Regarding manual programming of devices, a study in the American Journa/ of Health-System Pharmacy 

found that IV interoperability reduced the time to program "smart" infusion pumps by 23 seconds per setup." 

Extending this over the nearly 750,000 smart pumps estimated to be in use across U,S. hospitals today 

without EHR integration," assuming two pump setups per day, and the same nurse salary used above, this 

amounted to nearly $175 million in annual savings (see the Appendix for step-by-step calculations). 

In total, widespread interoperability could save nurses' time valued at nearly $12.3 billion, or 7 percent 

of total nurse salaries, representing the cost of over 115,000 nurses. 

Studies suggest that the nursing shortage (estimated at 135,000 vacancies in 2008)33 may have 

temporarily abated due to the economic downturn, but the shortage is likely to return as the economy 

recovers and more Americans gain health insurance (with estimates predicting a shortage as high as 500,000 

nurses by 2025).34 Rather than resulting in staff reductions or avoidance of additional hires, these efficiency 

gains would likely translate into the ability to serve an increasing volume of patients with the current number 

of nurses, avoiding a future shortage. It could also allow hospitals to increase the amount of nurse time 

devoted to direct patient care, which has been shown by numerous studies to have a positive impact on 

patient outcomes and could generate potentially larger savings forthe system." 

The Value of Medical Device Interoperability 

West Health Institute 18 
42 


80806.070

Additional Factors to Consider 

The $12.4 billion value calculated above represents a conservative estimate of the clinician time saved 

through greater interoperability for several reasons. First, the calculations only examined the impact on 

nurses' time saved, as this was the impact most widely measured in the clinical literature, but Rausch and 

Judd suggest that greater interoperability could save time for support staff as well." Physicians also waste 

time collecting information from disparate sources while making rounds. Thus physician time could be saved 

by consistent and comprehensive presentation of data generated by medical devices. Both physicians and 

nurses could potentially save additional time from streamlining operating room and other patient safety 

checklists by automatically populating information from the relevant medical devices. Furthermore, the 20 

percent time savings used represents a low estimate of the time savings found in the literature, with several 

studies finding time savings of 40 percent or more.36." It is worthwhile to note that the gains associated with 

interoperability's effect on nursing time may differ greatly by region, as nurse wages show significant regional 

variation. Another conservative limitation to the estimate above is its calculations of device programming 

time looked only at smart pumps, omitting other programmable devices (e.g., ventilators), though given that 

most devices do not require nearly the same level of programming, the additional impact of this may be 

relatively small. These several factors suggest that the actual value created in this category could be two to 

three times as large as that estimated in this analysis. 

4. Costs Resulting from Increased Length of Stay: $17.8 billion 

With and Without Medical Device Interoperability 

Delays in receiving test results hinder decision making, unnecessarily extending the length of emergency 

department visits and inpatient hospital stays. Medical device interoperability, by pushing test results to the 

clinician, would accelerate decision making, reducing length of stay and providing opportunities for "rightsizing" of departments or avoidance of future staff augmentation. 

Calculatians 

Within the emergency department, the impact on length of stay of reduced test turnaround time due to 

satellite point-of-care testing was used as a proxy for the impact of greater interoperability, given that 

interoperability is expected to reduce length of stay through a similar mechanism - increased speed of test 

results. A study in the Archives of Pathalogy and Laboratory Medicine found that by decreasing test 

turnaround time by an average of 87 percent, ED point of care testing decreased length of stay by 41 

minutes!' Extending this across the more than 136 million ED visits per year, each with an average stay of 

approximately 3.5 hours,'9 would result in a total reduction in length of stay equal to more than 26 million 

additional ED visits eliminated each year. Valuing each visit at an average cost of $380'0 would yield potential 

savings of nearly $9.9 billion annually, or 19 percent of total ED spending. 

Hospitals could realize these savings in a variety of ways, such as reducing or repurposing ED resources. 

Alternatively, given that nearly 3 percent of attempted visitors currently leave without being seen,41 hospitals 

might use the additional capacity to better serve this cohort, potentially resulting in increased throughput and 

revenue of as much as $1.5 billion, but for the sake of this analysis, the impact was captured as savings. 

The Value of Medical Device Interoperability 

West Health Institute 19 
43 


80806.071

With regards to inpatient stays, the impact of reduced test turnaround time due to combining 

computerized physician order entry (CPOE) with electronic medication administration records was used as a 

proxy for the impact of greater interoperability because it looked at the impact of faster test results on length 

of stay, this time through the integration of clinical systems. A study in the Journal of the American Medical 

Informatics Association found sizeable reductions in radiology procedure completion and lab result reporting 

times which resulted in a decrease from 3.91 to 3.71 days in severity-adjusted length of stay in one hospital, 

and no significant impact in the other.42 Using this as a proxy for the impact of medical device interoperability 

yields an average impact of 0.1 day reduction in length of stay. Extending across more than 39 million annual 

inpatient stays, 6 each averaging 4.6 days· and $9,200 in cost,' yields estimated reduction in inpatient stays 

worth $7.9 billion, or 2 percent of total inpatient spending. 

In total, the value of reduced length of stay due to medical device interoperability comes to $17.8 billion, 

or 4 percent of total Emergency Department and Inpatient costs. 

Additional Factors to Consider 

In addition to reducing length of stay, the timely transfer of information provided by medical device 

interoperability would improve the quality of care by enhancing clinical decision·making through the 

presentation of comprehensive, up-to·date information to clinicians. For example, medical device integration 

at St. John's Medical Center increased its vital sign charting frequency from every 15 minutes to every five 

minutes, which helped to improve patient outcomes and overall quality of care.43 

Lack of Commonly Adopted Standards 

The preceding section discusses waste in the health care system due to the lack of interoperability - the 

inability for devices to electronically share data and information with each other and with hospital 

information systems and to enable cliniCians to act upon this information. As discussed in the introduction, 

the most common solution to addressing these issues today is the development of customized interfaces 

between devices, as the diverse implementations and limitations of currently adopted standards do not allow 

"plug-and-play" interoperability. But this lack of commonly adopted standards itself results in further waste, 

as device manufacturers must incur testing and development costs to facilitate interoperability with a diverse 

range of systems, and health care providers must, in addition, invest resources to integrate devices with EHRs 

and other information systems. These costs, in turn, inhibit a move to greater interoperability across the 

health care system. 

5. Device Development and Testing Costs 

In interviews conducted with device manufacturers, estimates of the costs of developing and testing 

devices to facilitate interoperability with EHRs varied by manufacturer, averaging $740,000 per device per 

EHR.44 An estimated 235 potentially interoperable devices are approved by the FDA each year, 45 but 

interviews with manufacturers suggested that, at most, half of the devices released each year involve 

additional investments to facilitate interoperability. These assumptions result in an estimated $87 million in 

development and testing costs across the industry to achieve interoperability with each EHR vendor. Using the 

conservative assumption that device manufacturers seek to achieve interoperability with six other systems on 

The Value of Medical Device Interoperability 

West Health Institute 20 
44 


80806.072

average (the top six EHR vendors account for 80 percent of market share,'· making them the most likely 

candidates for interfacing) yields annual industry-wide testing and development costs of more than $520 

million today. While adopting standards will include short-term increases in costs, in the longer term, overall 

industry testing and development related to interoperability would likely decline relative to the expenses 

incurred today. If vendors only had to achieve interoperability with one common set of standards, these costs 

could drop to $87 million, saving approximately $430 million in device development and testing costs 

industry-wide, or nearly 2 percent of total industry research and development (R&D) spending.47 

6. Provider Integration Costs 

It is important to note that a substantial proportion of the costs of interoperability are also passed on to 

providers, with deVice companies in some cases supporting interoperability between their device and hospital 

systems on an as-requested basis. Hospitals spend billions of dollars annually on EHR implementation" and 

hospital development and integration, a portion of which is invested in achieving medical device 

interoperability. 

Starting with one-time integration costs of $10,000 per bed per year,4 and assuming 7 percent of 

hospitals integrate devices to EHRs per year (based on the percentage of hospitals moving into advanced 

stages of EHR adoption each year49), and 15 percent annual maintenance costs for the 33 percent of hospitals 

with a level of current interoperability,' annual provider investment in interoperability is estimated at $1.1 

billion. Assuming that 66 percent of these costs could be reduced with commonly adopted standards, as 

hospitals go from using three different sets of interfaces (based on the HIMSS Analytics finding' that hospitals 

integrate an average of three types of devices today) to one set of interfaces would yield an estimate of nearly 

$740 million in potential annual savings. 

Given the substantial costs of integration, reducing these costs through convergence on common "plugand-play" standards could greatly accelerate the move to medical device interoperability among providers, 

much as convergence on the USB standard revolutionized interoperability for computer peripherals and other 

electronics, with more than six billion USB-enabled products sharing information today.'o 

The Value of Medical Device Interoperability 

West Health Institute 21 
45 


80806.073

Who Benefits? 

A high-level analysis suggests that the majority of benefits related to increased medical device 

interoperability and improved adoption of common standards for interoperability may accrue to providers (93 

percent), followed by payers (6 percent) and patients (1 percent) (Figure 9). 

Figure 9: Savings by Stakeholder 

1. Adverse events avoidable with medical device interoperability 

2. Redundanttesting resulting from inaccessible information 

3. Clinician Time Spent Manually Entering Information 

4. Increased length of stay from delays in information transfer 

Total Savings ($M) 

Total Savings (%) 

Note: Numbers rounded for ciarity 

5. Device testing and development costs 

devices with EHRs 

$1,000 $850 $150 

$1,500 $1,275 $225 

$12,300 

$17,800 

$32,600 $2,125 $375 

93% 6% 1% 

Providers Payers Patients 

$740 

$0 

0% 

Device 

Vendors 

$430 

Savings from avoidance of adverse events would accrue in part to providers, payers and patients. While 

payers and patients typically bear the costs of treatment, payers are increasingly penalizing providers for 

preventable adverse events by limiting or denying reimbursement. The extent to which each stakeholder 

bears costs and accrues benefits varies by payer and by type of event (e.g. never events), making it difficult to 

quantify the precise proportion of savings accruing to each stakeholder. To provide a directional estimate, it 

was assumed that the benefits are split in half with providers gaining roughly $500 million. The remaining 

$500 million is divided between payers and patients based on the ratio of national health expenditure for 

each, 85 percent ($425 million) and 15 percent ($75 million) respectively. 

The Value of Medical Device Interoperability 

West Health Institute 22 
46 


80806.074

As with adverse events, reimbursement for redundant testing varies based on payer contracts, and 

reimbursement trends are moving to deny payment for tests already performed. For reasons similar to those 

above, providers have been assumed to bear half the costs of such testing, and therefore capture 50 percent 

of the savings. The remaining 50 percent was again allocated to payers and patients based on the ratio of 

national health expenditure for each. 

Savings from decreased length of stay are assumed to accrue entirely to providers, who are typically paid 

a flat fee for visits regardless of length of stay. Likewise, providers bear the full costs of nurse salaries, and 

therefore capture the entirety of the savings relating to time wasted manually entering information. 

Medical device companies accrue all benefits that may result from the reductions in research and 

development resulting from common adoption of standards for interoperability, and providers accrue the 

related reductions in capital and development expenditure and maintenance created by avoiding custom 

integration solutions. 

Additional Benefits Not Quantified 

lack of Medical Device Interoperability 

The benefits discussed above form the core case for interoperability, representing benefits that could be 

realized directly. However, there are a number of additional benefits enabled by interoperability which are 

more difficult to quantify or require additional enabling factors to be realized. 

Greater medical device interoperability could enable rapid advances in clinical decision support, as the 

continuous flow of patient-specific physiologic information (e.g., vital signs) to data repositories would enable 

advanced data analytics. This combination of real-time patient data can help to achieve clinical workflow 

improvements not realizable today and result in improved affordability of medical care, the impact of which 

cannot be quantified prospectively. 

Stakeholders would also see benefits of interoperability when using remote patient monitoring systems 

with the EHRs, which would facilitate viewing of patient-generated data alongside clinically generated data. 

Remote patient monitoring has been shown to reduce costs and improve outcomes in a number of studies,51 

and by integrating data into providers' workflow, interoperability could encourage provider adoption and 

further improve efficacy. Additionally, the interoperable transfer of non-clinical device data (e.g., battery 

status, need for software updates, device location, etc.) would enable the automation of device maintenance 

currently managed manually, as well as improve inventory and utilization management. 

Patients would benefit through reduced premiums and improved care, as well as improved experiences in 

the system. First, they will spend less time on medical care, as patient time wasted due to redundant tests, 

extended length of stay and redirects from overcrowded emergency rooms to available hospitals effectively 

represents foregone wages. Additionally, preventable adverse events result in not only increased medical 

costs but also increased mortality. While these are significant sources of value, these productivity and 

mortality benefits are not typically induded in the $700 billion estimates of waste in the health care system, 

and therefore have been excluded from this analysis. 

The Value of Medical Device Interoperability 

West Health Institute 23 
47 


80806.075

Lack of Commonly Adopted Standards 

Commonly adopted standards would also create several additional sources of value beyond the savings 

estimated above. According to interviews with health system engineering experts, the custom interfaces 

required today pose the risk of a high volume of systematic medical errors if developed incorrectly, and 

writing and maintaining these interfaces to a high level of reliability is difficult and expensive for device 

manufacturers, particularly as the supply of qualified labor becomes increasingly scarce. By reducing the need 

for custom interfaces, commonly adopted standards would lessen these costs and risks. 

Furthermore, the costs of proprietary interfacing with a variety of EHRs and other hospital information 

systems limits innovation among device manufacturers, particularly smaller players, who lack the scale to 

recover these fixed interoperability costs. As has been seen in other industries with the adoption of USB and 

wireless communication standards, commonly adopted standards allow small companies to quickly and 

efficiently create and bring new technologies to market. This not only lowers the barriers to innovation for 

small device manufactures and start-up companies, but can also be a major influence in fueling the economic 

growth. 

This increase in innovation and competition WOUld, in turn, allow providers to choose from a broader 

range of devices and potentially result in reduced prices paid for devices and greater innovation in new 

devices -benefits difficult to quantify, but repeatedly mentioned by provider interviewees. These benefits 

would be further bolstered by a reduction in switching costs, compared to the current situation where 

investments in interoperability with a given vendor's devices create substantial barriers to a hospital buying 

devices from different vendors in the future. 

The Value of Medical Device Interoperability 

West Health Institute 24 
48 


80806.076

Conclusion 

Summary 

This study estimates that widespread medical device interoperability can eliminate $36 billion of waste in 

the health care system. Functional interoperability leads to increased efficiency, lower costs and better quality 

of care through four primary drivers: 1) quality improvement through reduction of adverse events due to 

safety interlocks ($1.9 billion), 2) reduced cost of care secondary to avoidance of redundant testing ($1.5 

billion), 3) increased clinician productivity secondary to decreased time spent manually entering information 

($12 billion) and 4) improvements in patient throughput secondary to shortening length of stay ($18 billion). 

Impact on Efficiency 

The reduction in clinician time spent manually entering information allows providers to improve 

workflow and optimize staffing models. Physicians and nurses can redirect time saved for value-added 

activities such as direct bedside care, patient education and care coordination. In addition, providers can 

allocate time to fulfill the requirements established by value-based purchasing and hospital readmissions 

reduction programs. With an aging population and expansion of insurance coverage leading to increased 

demand for services, providers are more prepared to respond to the call to provide better care at a lower 

cost. 

Through timely access to relevant and complete clinical information, medical device interoperability can 

shorten length of stay and create additional capacity without an increase in cost. Shorter length of stay is 

attained by improving the quality of care for existing patients. Increased capacity creates an opportunity for 

providers to right-size their departments, achieve appropriate bed utilization and management metrics and 

expand access to care for patients not currently being served in the system. 

Impact on Costs and Quality 

Interoperability drives direct cost savings by decreasing the number of procedures completed through 

avoidance of redundant testing and adverse events. The "data push" capabilities enabled by functional 

interoperability will help overcome the latency or inaccuracy of reporting test results that often result in 

redundant testing today. A reduction in adverse events driven by safety interlocks enabled by interoperability 

also results in direct savings by removing the cost of care associated with treating patients who experience 

these events. The distribution of these cost savings will depend on the contracts established between payers, 

providers and patients. 

A system-wide improvement in quality of care is achieved through automation of processes and 

reduction of the number of opportunities for human error. Adverse events decline as clinical work flow is 

simplified and the number of steps to diagnose and treat a patient is reduced. Avoiding redundant testing also 

The Value of Medical Device Interoperability 

West Health Institute 25 
49 


80806.077

improves the patient experience and overall quality of care by reducing the number of procedures a patient 

must endure and the time the patient spends in the system. 

Limitations and Areas for Further Research 

This analysis was undertaken to estimate the magnitude of potential health care delivery cost savings 

resulting from the availability and widespread adoption of true, functional medical device interoperability. As 

there are few examples of such plug-and-play interoperability, a variety of assumptions and extrapolations 

from surrogate circumstances were employed, referenced as appropriate to guide the reader. Nonetheless, 

the nature of this work does not afford absolute precision, but rather an order-of-magnitude estimate. 

Additionally, the current cost of achieving medical device interoperability and, in turn, the potential savings 

from common adoption of standards are less certain than the estimates of waste addressed by 

interoperability itself. There is limited research available on the costs of provider integration and limited 

consensus from stakeholders on the proportion of device development and testing costs and provider 

integration costs that would be eliminated with commonly adopted standards. This remains an important area 

for further research, as the substantial costs of achieving interoperability represent a significant barrier to 

realizing the efficiency, cost and quality benefits detailed above. Experience in other industries suggests that 

commonly adopted standards would indeed have the desired impact of accelerating adoption and potentially 

reducing costs of integration, and this should be further examined as a potential solution for medical device 

interoperability. 

The Value of Medical Device Interoperability 

West Health Institute 26 
50 


80806.078

Call to Action 

Given the opportunity to improve patient care and reduce health care spending by more than $30 billion per 

annum, the question that follows is how to drive a shift from the current state with a lack of widespread 

medical device interoperability to a fully networked health care system where the substantial benefits of 

interoperability can be realized. 

Current Efforts towards Increased Interoperability 

A number of organizations are working to further medical device interoperability in the clinical 

environment by promoting various means of standardization. However, no single effort has reached critical 

levels of adoption. One approach, developing prescribed profiles to facilitate consistent implementation of 

communication standards, is being led by Integrating the Healthcare Enterprise (IHE), a broad initiative of 

health care and health information technology stakeholders. This group creates profiles based on existing 

standards bodies such as IEEE and Hl7. The North American branch of IHE facilitates an annual connect-a-thon 

to validate profiles and hosts a number of demonstrations through an Interoperability Showcase at the HIMSS 

national meeting. Other efforts include the Medical Device "Plug-and-Play" (MD PnP) Interoperability 

Program, which has "been working to accelerate the adoption of medical device interoperability by providing 

interoperability building blocks (use cases, standards, a neutral lab environment and open research tools) and 

by changing clinical and market expectations of what can be achieved."S2 Most recently, the Association for 

the Advancement of Medical Instrumentation (AAMI) announced a partnership with the testing, certification 

and standards development organization Underwriters laboratories (Ul) to develop a suite of standards on 

medical device interoperability, aiming "not to supplant existing standards or profiles," but rather "to map 

them into a framework and address further safety issues where applicable."" 

In the consumer medical device realm, the Continua Health Alliance is promoting the adoption of 

common standards for interoperability. Meanwhile, a number of consumer-driven medical device companies 

are taking a market-wide approach to interoperability through the use of Application Programming Interfaces 

(APls), with companies such as Fitbit using APls to share data between activity sensors, smartphones, 

computers and applications. The clinical device sector has seen limited application of this type of approach. 

Additionally, in the clinical medical device realm, purchasing behavior of providers has yet to require this level 

of "plug-and-play" interoperability now common among consumer electronics. There are several efforts that 

provide requirements guidance for medical device interoperability. For example, Medical Device "Free 

Interoperability Requirements for the Enterprise" (MD FIRE)" comprises a white paper and sample RFP and 

contracting language. The IHE Patient Care Device User Handbook also describes how and why to acquire and 

implement systems and devices for device interaction. However, these efforts and efforts by many indiVidual 

hospital systems have yet to be utilized on a broad scale. While consumers quickly drive technology to 

common standards for ease of use and rapid adoption, hospitals have yet to share a common voice related to 

requirements for medical device interoperability. 

The Value of Medical Device Interoperability 

West Health Institute 27 
51 


80806.079

Who Will Lead the Way? 

Despite the numerous activities promoting standardization for medical device interoperability, no 

common approach has been adopted widely. The value proposition presented above suggests that it is 

unlikely medical device and IT companies will proactively move towards standardized "plug-and-play" device 

interoperability, and that providers may have the most significant burning platform for promoting medical 

device interoperability as a solution to the efficiency, capacity and cost issues they are currently facing, 

supported by pressure from payers changing to more value-based payment models. 

Device Manufacturers 

In order to drive rapid adoption of medical device interoperability, incentives for device companies, who 

will bear the cost to develop the capability within devices, must be aligned with those of the remaining health 

care stakeholders, who reap the benefits of increased interoperability and adoption of standards. Discussions 

with medical device industry leaders highlight the fact that although technology to generally enable 

interoperability exists, market forces today do not create the aligned incentives to produce devices with 

consistent modes for interoperability. 

As discussed previously, device manufacturers are unlikely to see substantial benefits from either 

increased interoperability or commonly adopted standards. The latter would likely be viewed as diminishing 

the competitive advantage of large companies who currently tout integration among their own closed system 

of devices as a benefit of purchasing their bundled device solutions. Moreover, interviewees expressed 

concerns that the development and testing costs involved in moving to consistent industry-wide standards 

would be substantial in the short-term relative to the longer-term gains in development costs avoided 

through convergence on standards. As a result, device manufacturers may not have strong incentives to 

organically lead the charge towards common adoption of open, plug-and-play interoperability standards until 

their customers - health care providers coordinate to provide dear requirements to conSistently, perhaps 

even fully integrated with their procurement processes. 

Providers 

Providers accrue the vast majority of benefit from medical device interoperability at $33 billion, or 93 

percent of the total, primarily due to productivity gains from improved workflow. However, few, if any, 

providers have achieved functional interoperability, and those that have typically created customized closed 

systems that are not scalable solutions for the rest of the industry. A 2010 HIMSS Analytics study suggests that 

more than two-thirds of providers have entirely forgone the investment required to obtain any level of 

benefits from functional interoperability to date.' 

Interviews indicated that the benefits of interoperability are not well documented and are currently 

superseded by other decision-making criteria, such as current regulation and limited budgets for competing 

The Value of Medical Device Interoperability 

West Health Institute 28 
52 


80806.080

projects. Many providers are currently most concerned with meeting the immediate, Stage 1, requirements 

for Meaningful Use of EHRs, incentivized by deadlines for funding from the Centers for Medicare and 

Medicaid Services (CMS). Stage 1 requirements create minimal standards for sharing selected and prescribed 

information among stakeholders - an important first step, but a far cry from the interoperability requirements 

needed to realize the benefits detailed above. Based on the recent Stage 2 requirements and proposals for 

Stage 3, Meaningful Use is missing an opportunity to advance medical device interoperability. Although 

Meaningful Use requirements can establish important prerequisites for collecting device information, they do 

not currently drive functional medical device interoperability. 

Aside from their current focus on basic Meaningful Use, an additional challenge for providers is that they 

too could incur an appreciable investment of resources to build the infrastructure and replace legacy medical 

devices to demonstrate interoperability. However, as identified above, the productivity gains and cost savings 

created by the improved workflow facilitated by medical device interoperability can create a substantial 

return on these investments. 

To realize these returns, providers need support of technology and device companies to address the 

workflow integration, as well as financial incentives to prioritize interoperability over other investments. If 

providers begin to consistently require interoperability as a key component in request for proposals (RFPs) for 

new equipment, they can steer the device and technology industries to resolve the workflow needs and adopt 

more standard means for implementation of interoperability. This would require increased coordination and 

collaboration among the various parties currently focused on developing standards and guidelines for 

interoperability. Additionally, a continued shift toward capitation models by payers will put pressure on 

providers to aggressively manage limited resources and create a sense of urgency around investments that 

can improve productivity, such as medical device interoperability. 

Payers and Government 

Payers and the government (both in its role as a payer through Medicaid and Medicare and more broadly 

in its position as a regulator with the responsibility to address market failures) are also poised to influence the 

speed of medical device interoperability. While the analysis in this paper suggests that payers capture a much 

smaller proportion of benefits from interoperability than providers, payers will secondarily benefit from the 

reduced cost of services and improved health outcomes associated with the efficiency gains of providers. 

Additionally, many of the benefjts not quantified in this analysis, such as improved adoption and efficacy from 

remote patient monitoring and the ability for advanced data analytics would result in reduced costs to payers. 

A continued shift in the payment system from fee-for-service to capitation or other value-based approaches 

will accelerate the need for providers to improve workflow to achieve better outcomes with fewer resources. 

The federal government is already taking steps to incentivize greater interoperability. Broadening 

Meaningful Use requirements to incorporate functional medical device interoperability could playa crucial 

role in driving greater interoperability throughout the health care system; however, it would be about five 

years before this incentive took effect. Government and private payer reimbursement practices will need to 

be primary drivers to promote provider implementation of medical device interoperability in order for the 

system to more rapidly realize the savings estimated in this report, similar to how future payments to 

The Value of Medical Device Interoperability 

West Health Institute 29 
53 


80806.081

providers will be tied to complying with Meaningful Use, readmission and other emerging performance 

standards. 

The continued convergence of payers and providers will create a strong platform for accelerating medical 

device interoperability. Accountable Care Organizations (ACOs), for example, could be a driver of medical 

device interoperability, given their need to achieve cost savings while integrating large and disparate networks 

across EHRs and HIEs. Although ACO participation is currently low, with only 13 percent of hospitals reporting 

current participation in an ACO or plans to do so within a year according to the Commonwealth Fund, other 

models of care coordination and collaboration for improved population health management will drive similar 

needs for the efficiency and quality improvements that can be provided by medical device interoperability.54 

Coupling this convergence with the systemic capacity challenges providers already face due to increasing 

demands on the system from 30 million new consumers entering the health insurance market, a rapidly aging 

population and predicted clinician shortages, providers are finding themselves on a burning platform that 

requires them to do more with less. This creates a strong case to redirect investment toward medical device 

interoperability due to its significant impact on clinician productivity and cost reduction. 

The Value of Medical Device Interoperability 

West Health Institute 30 
54 


80806.082

Appendix: Detailed Calculations 

lack of lnteroperability 

Adverse Events: Drug Errors 

1 Value of adverse event costs attributable 

to drug errors ($K) 

2 X % of drug errors due to ordering errors 

3 X % preventable by interoperability 

[A] Value of reduced ordering-re/oted 

adverse events ($K) 

5 

6 Value of adverse event costs attributable 

to drug errors ($K) 

7 % of drug errors due to transcription 

x errors 

8 x % preventable by interoperability 

9 [B} Value af reduced transcriptionrelated adverse events ($K) 

10 

The Value of Medical Device Interoperability 

West Health Institute 

Notes 

$3,800,000 [9J 

[11] 

47% [12J 

$702,000 

$3,800,000 [9J 

[l1J 

[11] [13] 

$342,000 

31 
55 


80806.083

Adverse Events: Drug Errors - continued 

11 Value of adverse event costs attributable 

to drug errors ($K) 

12 % of drug errors due to administration 

x errors 

13 x % due to intravenous medications 

14 % preventable by integrated infusion 

15 

x pumps 

{C] Value of reduced administrationrelated adverse events ($K) 

16 [A] + [BJ + [C] = Total potential drug 

error-related savings from 

interoperability ($KI 

Adverse Events: Diagnostic Errors 

Total cost of preventable adverse events 

($K) 

% of adverse events due to diagnostic 

errors 

3 Value of adverse event costs attributable 

to diagnostic errors ($K) 

4 % of diagnostic errors addressable by 

device interoperability 

5 Potential diagnostic error-related savings 

from interoperability ($K) 

Blue 

Adverse Events: Failure to Prevent Injury 

The Value of Medical Device Interoperability 

West Health Institute 

$3,800,000 Calculated above 

$277,248 

$1,321,248 

$16,600,000 

$2,884,050 

$465,630 

[l1J 

[14J 

[15J 

[9J 

[10J 

[16J 

Notes 

32 
56 


80806.084

Ventilator-Associated Pneumonia 

Total annual cost of ventilator-associated 

pneumonia ($K) $1,140,000 

Notes 

Estimates range from $780M to 

$1,5B; midpoint used, [18] 

2 Ventilator-assisted pneumonia 

Reduction in ventilator-associated reduced from 75 to 3,2 per 1000 

x pneumonia due to bundle of interventions ventilator days, [17] 

3 x % attributable to device interoperability Based on industry interviews, 

4 Potential ventilator-associated pneumonia 

savings from interoperability ($K) $163,400 

Postoperative Shock 

1 Total number of postoperative shock 

incidents caused by errors annually 

2 

3 

4 

I 

5 

x Medical cost per error ($K) 

Total medical cost of postoperative shock 

errors ($K) 

x % Reduction due to device interoperability 

Potential postoperative shock-related 

savings from interoperability ($K) 

The Value of Medical Device Interoperability 

West Health Institute 

748 

47 

$35,230 

$22,196 

Notes 

[9] 

Mortality cost per error ($46,584) 

not included, [9] 

Continuous pulse ox surveillance 

reduced !!rescue events!! from 3.4 to 

1,2 per 1000 patient discharges, [19] 

33 
57 


80806.085

Redundant Testing 

2 

4 

Direct costs of redundant tests in U.S. 

hospitals ($K) 

% of duplicative tests due to lost 

x information 

x % avoided due to interoperability 

Potential costs saved by medical device 

interoperability ($K) 

numbers 

The Value of Medical Device Interoperability 

West Health Institute 

Notes 

$3,172,000 [9J 

$3,035,489 

14.5% of testing process errors 

due to charting or filing errors; 

24.6% due to failure to report 

results to physicians. [22J 

99% number from [23J 

corroborated by qualitative 

commentary in [24J. 95% value 

used to be conservative. 

34 
58 


80806.086

Wasted Clinician Time: Manually Entering Vital Signs Readings 

% of time spent on documentation 

2 x Average annual salary for nurse 

3 

4 

5 

6 

B!ue 

Total number of registered nurses (RNs) in 

U.s. hospitals 

Total value of nurse time spent on 

documentation per year ($K) 

x % of time saved due to interoperability 

Total potential annual savings in nurse 

salaries ($K) 

The Value of Medical Device Interoperability 

West Health Institute 

1,512,000 

$60,602,334 

$12,120,467 

Notes 

Assumed to be constant for 

hospitals with and Without EHRs 

(studies find varying effects) 

[27J 

$50/hour total compensation 

for hospital RNs [31], x 2130 hrs 

worked/year [30J 

2.6M licensed RNs employed in 

nursing, 62% of those work in 

hospitals [29J 

[28J 

35 
59 


80806.087

Wasted Clinician Time: Manually Programming Devices 

1 

2 

3 

Reduction in programming time per smart 

pump setup (min) 

x Number of infusion setups per smart 

pump per year 

Hours saved in setups per smart pump per 

year 

4 x Number of smart pumps in use across U.S. 

5 

6 

7 

% of hospitals not interfacing smart pump 

with EHR today 

Hours saved in pump setups across U.s. 

per year 

x Average hourly salary for nurse 

Total potential annual savings in nurse 

salaries ($Kl 

Blue rumbers 

The Value of Medical Device Interoperability 

West Health Institute 

0.4 

730 

5 

3,497,806 

$174,890 

Notes 

23 seconds per setup. [5J 

Assumption - 2 readings/day x 

365 days/yr 

5,754 U.s. hospitals [55J x 50% 

using smart pumps x 

280/hospital [3J 

[3J 

[31J 

36 
60 


80806.088

Increased Length of Stay 

Emergency Department 

Total number of ED visits 

x Reduction in ED time (hours) 

3 Maximum hours of ED time gained 

4 Average length of ED visit (hours) 

5 Number of ED visits saved 

6 

x Average cost of ED visit 

1 Value of ED visits reduced ($KI 

Inpatient 

1 Total inpatient stays 

2 x Reduction in length of stay (days) 

3 Total days of inpatient time gained 

4 Average length of inpatient stay (days) 

5 Number of inpatient stays saved 

6 

7 

The Value of Medical Device Interoperability 

West Health Institute 

136,072,000 

92,982,533 

26,266,252 

$9,883,046 

39,400,000 

0,1 

3,940,000 

4.6 

856,522 

[39] 

[38J 

[39J 

Notes 

$52B total ED expenses and 136M 

visits [40J 

Notes 

[6J 

[42J 

[6] 

[6] 

37 
61 


80806.089

Lack of Commonly Adopted Standards 

Device Development and Testing Costs 

Testing and development costs per 

EMR interface, per device ($K) 

2 II of potentially interoperable devices 

x developed per year, industry-wide 

3 % of devices with interoperabilityx related development 

4 Costs per EMR interface (industrywide) (SK) 

5 Average II of EMR interfaces required 

x today (per device) 

6 [A] Total testing and development 

costs today ($Kj 

7 Costs per EMR interface (industrywide) ($K) 

8 Average II of EMR interfaces required 

x in future state 

9 [B] Total testing and dev. costs in 

future state ($K) 

10 !AJ - !S] = Savings on testing and dev. 

costs ($K) 

Blue 

The Value of Medical Device Interoperability 

West Health Institute 

$86,827 

$520,960 

Notes 

Estimates from vendor interviews 

ranged from $350K to SUM; 

midpoint used 

Based on FDA 510k approvals data 

Based on vendor interviews 

[46] 

$86,827 From line 4 above 

Based on vendor interviews 

$86,827 

$434,133 

38 
62 


80806.090

Provider Integration Costs 

2 Average number of staffed beds nationwide per 

x hospital 

3 Average integration costs per hospital ($K) 

4 x Number of hospitals nationwide 

5 x % with integrated devices (installed base) 

6 Annual maintenance as % of one-time 

x integration 

7 [A] Annual maintenance costs nationwide ($K) 

8 Average integration costs per hospital ($K) 

9 x Number of hospitals nationwide 

10 % of hospitals integrating devices to EMR per 

x year 

11 IB} Annual one-time costs nationwide ($K) 

12 [A] + IB] Estimated total integration spending 

($K) 

13 x Share reduced by implementation of common 

standards 

Total potential savings ($Kj 

Blue 

The Value of Medical Device Interoperability 

West Health Institute 

Notes 

[4] 

[55] 

$1,637 

[55] 

[3] 

Industry standard, based on 

interviews 

$466,288 Calculated 

$1,637 From above 

5,754 From above 

[49] 

$649,977 Calculated 

$1,116,264 Calculated 

Standardized from 

3 to 1 interfaces (average 

number of integrated devices 

$736,734 today is 3, according to [3]) 

39 
63 


80806.091

NOTES 

1 Smith M, Saunders R, Stuckhardt L, McGinnis JM, editors. Best care at lower cost: the path to continuously learning 

health care in America [Internetj. Prepublication copy. Washington: National Academy Press; 2012 [cited 2012 Oct 25J. 

Available from: http://www.iom.edu/Reports/2012/Best-Ca re-at-Lower-Cost-The-Path-to-Continuously-Learning-HealthCare-in-America,aspx. 

2 The seminal study on this subject was conducted by RAND: see Hillestad R, Bigelow J, Bower A,Girosi F, Meili R, Scoville 

Ret al. Potential health benefits, savings, and costs: can electronic medical record systems transform health care? Health 

Aff (Millwood). 2005;24(5):1103-1117. 

3 HIMSS Analytics. Medical devices landscape: current and future adoption, integration with EMRs, and connectivity 

[Internetj. Chicago: HIMSS Analytics; 2010 [cited 2012 Oct 2Sj. Available from: 

http://www.himssanalytics.org/docs/medicaldevices-,andscape.pdf. 

4 Moorman B. True costs of device connectivity. Presented at: Meeting of the Association for the Advancement of 

Medical Instrumentation; 2010 Jun. 

S HealthLeaders Media [Internetj. Updated 2012 Jul, cited 2012 Nov 6. Factfile: hospital margins. Available from: 

http://www.healthleadersmedia.com/content/281739.pdf. 

'Oh J. Average inpatient hospital stay shorter but more expensive in 2009 than 1997 [Internetj. Becker's Hospital 

Review; 2011 Dec 8 [cited 2012 Oct 26j. Available from: http://www.beckershospitalreview.com/racs-/-icd-9-/-icd10/ average-inpatient-hospita I-stay-shorter-but-more-expensive-in -2009-than-1997. html. 

7 For example, see the whitepapers by iSirona (Shenenberger PRo In the age of integration: benefits, costs, options and 

the future of medical device integration [lnternetJ. iSirona; 2012 [cited 2012 Oct 25J. Available from: 

http://learn.isirona.com/free-white-paper/), Nuvon (Good shepherd medical center device connectivity case study 

[Internetj. Nuvon; 2011 [cited 2012 Oct 25J. Available from: 

http://www.nuvon.com/pdf/Good%20Shepherd%20Medical%20Device%20Integration%20Case%20Study.pdf), and 

Lantronix (Thompson DI. Quantifying the business value of medical device connectivity [lnternetJ. Mesa (AZ): Black Box 

SME; 2011 [cited 2012 Oct 25J. Available from: http://www.lantronix.com/info/medical/blackbox-sme/). 

8 The Lean Six Sigma methodology identifies 8 types of waste, represented by the acronym DOWNTIME: Defects, or 

failure modes, Overproduction, Waiting, Non-utilized talent, Transportation, Inventory, Motion, Extra processing (rework 

and redundancies). 

9 Jha AK, Chan DC, Ridgway AS, Franz C, Bates DW. Improving safety and eliminating redundant tests: cutting costs in U.s. 

hospitals. Health Aff (Millwood). 2009;28(5):1475-1484. 

10 Kahn LT, Corrigan JM, Donaldson MS, editors. To err is human: building a safer health system [Internet). Washington: 

National Academy Press; 2000 [cited 2012 Oct 25J. Available from: http://www.nap.edu/catalog.php?recordJd.9728. 

11 Poon EG, Keohane CA, Yoon CS, Ditmore M, Bane A, Levtzion-Korach O. Effect of bar-code technology on the safety of 

medication administration. N Engl J Med. 2010;362:1698-1707. 

12 Franklin BD, O'Grady K, Donyai P, Jacklin A, Barber N. The impact of a closed-loop electronic prescribing and 

administration system on prescribing errors, administration errors and staff time: a before-and-after study. Qual Saf 

Health Care. 2007;16:279-284. 

13 Fiumara K, Moniz T, Churchill WW, Bane A, Luppi CJ, Bates DW, et al. Case study on the use of health care technology 

to improve medication safety [Internet}. In: Porche RA, editor. Medication use: a systems approach to reducing errors. 

Oakbrook Terrace (IL): Joint Commission Resources; 2007 [cited 2012 Oct 25j. p.l03-114. Available at: 

http://www.patientsafetyresearch.org/journal%20articies/Original%20260.pdf. 

14 Schilling MB, Muller S, Gerhart DC. Optimizing outcomes! Error prevention and evidence-based practice with IV 

medications [Internetj. ProCE, Inc.; c2002-2012 [cited 2012 Oct 25j. Available from: 

http://www.proce.com/IVintegration/. 

The Value of Medical Device Interoperability 

West Health Institute 40 
64 


80806.092

15 Prusch AE, Suess TM, Paoletti RD, Olin ST, Watts SD, Integrating technology to improve medication administration. Am 

J Health-Syst Pharm. 2011;68:835-842. 

16 Callen J, Georgiou A, Li J, Westbrook, JI. The safety implications of missed test results for hospitalised patients: a 

systematic review. BMJ Qual Saf2011;20:194-199. 

17 Jain M, Miller L, Belt 0, King D. Decline in ICU adverse events, nosocomial infections and cost through a quality 

improvement initiative focusing on teamwork and culture change. Qual Saf Health Care. 2006;15:235-239. 

18 Scott RD II. The direct medical costs of health care-associated infections in U.S. hospitals and the benefits of prevention 

[lnternetJ. Center for Disease Control; 2009 Mar [cited 2012 Oct 26J. Available from: 

http://www . vdh. virgin ia.gov / epidemiology /surveillance/hai/ docu ments/pdf/ScottArticie.pdf. 

19 Taenzer AH, pyke JB, McGrath SP. A review of current and emerging approaches to address failure-to-rescue. 

Anesthesiology. 2011 Aug;l1S(2):421-431. 

20 According to the study used (Jha, et aI., 2009 -- see note Errorl Bookmark not defined.), an error is defined as a 

preventable adverse event when a treatment that was likely to be harmful is administered or when evidence-based 

therapy that is known to reduce the likelihood of harm from medical care is not provided. 

21 Classen DC, Resar R, Griffin F, Federico F, Frankel T, Kimmel N, et a!. 'Global trigger tool' shows that adverse events in 

hospitals may be ten times greater than previously measured. Health Aff (Millwood). 2011 Apr;30(4):581-589. 

n Hickner et al. (2008) found that 14.5% of testing process errors are due to charting or filing errors; 24.6% due to failure 

to report results to physicians. (Hickner J, Graham DG, Elder NC, Brandt E, Emsermann CB, Dovey S, et al. Testing process 

errors and their harms and consequences reported from family medicine practices: a study of the American Academy of 

Family Physicians National Research Network. Qual Saf Health Care. 2008;17:194-200.) 

23 Gartner. eHealth for a healthier Europe - opportunities for a better use of healthcare resources [lnternetJ. Swedish 

Presidency of the European Union; 2009 [cited 2012 Oct 26J. Available from: 

http://www.se2009.eu/polopoly_fs/1.8227!menu/standard/file/eHealth%20for%20a%20Healthier''1020Europe.pdf. 

24 Hood MN, Scott H.lntroduction to picture archive and communication systems. J Radial Nurs. 2006 Sep;25(3):69-74. 

2S Calculated - see Appendix for details. 

26 Staiger DO, Auerbach 01, Buerhaus PI. Registered nurse labor supply and the recession - are we in a bubble? N Engl J 

Med. 2012 Apr 19;366:1463-1465. 

27 Hendrich A, Chow MP, Skierczynski SA, lu Z. A 36-hospital time and motion study: how do medical-surgical nurses 

spend their time? Perm J. 2008 Summer;12(3):25-34. 

Z8 Rausch TL, Judd TM. The development of an interoperable roadmap for medical devices. Proceedings of the IEEE 2006 

International Conference of the Engineering in Medicine and Biology Society; 2006: New York. 

29 American Nurses Association. Fact sheet: registered nurses in the U.S. - nursing by the numbers [Internet]. American 

Nurses Association; 2011 May [cited 2012 Oct 26J. Available from: 

http://n ursingworld .org/Nursi ngbytheN umbersFactSheet.aspx. 

30 Bureau of labor Statistics. Employer costs for employee compensation - June 2012 [lnternet1, U,S. Department of 

Labor; 2012 Sep 11 [cited 2012 Oct 26j. Available from: http://www.bls.gov/news.release/pdf/ecec.pdf. 

31 Health Resources and Services Administration. The registered nurse population: initial findings from the 2008 national 

sample survey of registered nurses [Internetj. U.S. Department of Health and Human Services; 2010 Mar [cited 2012 Oct 

26j. Available from: http://bh pro hrsa.gov thea Ithworkforce/rnsurveys/rnsu rveyinitiaI2008.pdf. 

"Calculated from HIMSS (2010) - note 3 - and AHA (2012) - note 55. See Appendix for details. 

33 American Association of Colleges of Nursing [lnternetJ. Washington, DC: American Association of Colleges of Nursing; 

[updated 2012 Aug 6; cited 2012 Oct 26j. Nursing shortage. Available from: http://www.aacn.nche.edu/mediarelations/fact-sheets/nursing-shortage. 

34 Buerhaus PI, Auerbach 01, Staiger DO. The recent surge in nurse employment: causes and implications. Health Aff 

(Millwood). 2009 July;28(4):657-668. 

The Value of Medical Device Interoperability 

West Health Institute 41 
65 


80806.093

35 KaiserEDU.org [Internetl. California: Kaiser Family Foundation; [cited 2012 Oct 26]. Nursing workforce. Available from: 

http://www .ka iseredu .org/lssue-Mod ules/N ursing-Workforce/Policy-Research.aspx. 

36 Meccariello M, Perkins D, Quigley LG, Rock A, Qiu J. Vital time savings: evaluating the use of an automated vital signs 

documentation system on a medical/surgical unit. JHIM. 2010 Fall;24(4):46-51. 

37 Donati AI Gabbanelli V, Pantanetti 5, et al. The impact of a clinical information system in an intensive care unit, J elin 

Manit Comput. 2008;22(1):31-36. 

3S Lee-Lewandrowski E, Corboy D, Lewandrowski K, Sinclair J, McDermot 5, Benzer TI. Implementation of a point-of-care 

satellite laboratory in the emergency department of an academic medical center. Arch Pathol Lab Med. 2003 

Apr;127:456-460. 

39 Centers for Disease Control and Prevention [Internet]. Atlanta: Centers for Disease Control and Prevention; [updated 

2012 Aug 20; cited 2012 Oct 261. Hospital utilization (in non-federal short-stay hospitals). Available from: 

http://www.cdc.gov/nchs/fastats/hospital.htm . 

40 Based on $51.199 billion in total ED expenses (AHRQ - see end of this note) divided by 136.072 million total ED visits 

annually (CDC - see note 25). Agency for Healthcare Research and Quality [Internet]. Maryland: U.S. Department of 

Health & Human Services; [cited 2012 Oct 26]. Medical expenditure panel survey. Available from: 

http://meps.ah rq .gov/mepsweb/data_stats/ta bles _compendia_ hhjnteractive.jsp _SERVICE-M EPSSocketO&_PROGRAMMEPSPGM.TC.5AS&File-HCFY2009&Table=HCFY2009_PLEXP _E&VAR1=AGE&VAR2=SEX&VAR3=RACETH5C&VAR4=INSUR 

COV&VAR5=POVCAT09&VAR6=MSA&VAR7=REGION&VAR8=HEALTH&). 

41 Landro L. ERs move to speed care; not everyone needs a bed [Internet]. Wall Street Journal; 2011 Aug 2 [cited 2012 Oct 

26]. Available from: http://online.wsj.com/articie/SB10001424053111904888304576476242374040506.html. 

42 Mekhjian HS, Kumar RR, Kuehn L, Bentley TD, Teater P, Thomas A, et al. Immediate benefits realized following 

implementation of physician order entry at an academic medical center. J Am Med Inform Assoc. 2002 Sep;9(S):S29-S39. 

43 Witonsky P. Leveraging EHR investments through medical device connectivity [Internet]. Healthcare Financial 

Management Association; 2012 [cited 2012 Oct 26]. Available from: 

http://www.hfma.org/T emplates/Pri nt.aspx ?id=33698. 

44 Some manufacturers estimated costs of as much as $1.2 million per line of FDA Class III devices to develop, test, and 

obtain regulatory approval for the interface to each vendor's EHR (and half that amount for Class II devices), others 

indicated that they only incur such interfacing costs for device gateways, estimated at approximately $350,000 per line of 

devices per EHR, and others said that they do not incur substantial device development costs to facilitate 

interoperability, aside from minimal costs to support EHR and middleware vendors by providing documentation, 

technical assistance, and sample devices. 

45 "Potentially interoperable devices" were defined as the devices listed in HIMSS (2010) - see note 3. According to S10K 

approvals data, the FDA approved an estimated 176 such devices from January to September 2012; annualizing this 

number yields 235 devices. (SlO(k) premarket notification [Internet]. Silver Spring (MD): U.S. Food and Drug 

Administration. [Updated 2012 Oct 19; cited 2012 Oct 26]. Available from: 

http://www .accessdata. fda.gov/scripts/ cdrh/cfdocs/cfPM N/pmn .cfm). 

46 Green C. The Health Care Blog [Internet]. San Francisco: Conor Green. 2012 Aug [cited 2012 Nov 5]. Available from: 

http://thehealthcareblog.com/blog/2012/08/06/n umbers-dont -lie-th e-ehr-market -must-consolidate/. 

47 MassDevice staff. Medical device companies, who spends the most on R&D [Internet]? MassDevice; 2012 Aug 14 [cited 

2012 Oct 26]. Available from: http://www.massdevice.com/news/medical-device-companies-who-spends-most-rd. 

48 Lewis N. EHR spending to hit $3.8 billion in 2015 [Internet]. InformationWeek; 2011 Jan 11 [cited 2012 Nov 6]. 

Available from: http://www.informationweek.com/healthca re/electron ic-medical-records/ ehr-spending-to-hit-38-billionin-2015/229000480 

49 Defined as hospitals moving into stages 4-7 of the HIMSS EHR adoption model from 2009-2010 and 2010-2011. Time 

period assumes 2-year lag between reaching those stages and medical device integration. Stages 4-7 seen as sufficiently 

advanced to benefit from medical device integration. Volumes calculated based on HIMSS EMRAM data. (Electronic 

The Value of Medical Device Interoperability 

West Health Institute 42 
66 


80806.094

medical record adoption model (EM RAM) [Internetj. Chicago: HIMSS Analytics; c2012 [cited 2012 Oct 26j. Available from: 

http://www .himssanaiytics.org/E MRam/index.aspx.) 

50 Perenson MJ. SuperSpeed USB 3.0: more details emerge [Internetj. PC World; 2009 Jan 6 [cited 2012 Oct 26j. Available 

from: http://www.pcworld.com/articie/156494/superspeed_usb.html· 

s1seethestudiescitedinBarnesK.waSdenC.GarrettD.Molioie W. Healthcare unwired. PwC's Health Research 

Institute; 2010 Sep. 

52 MD PnP [Internet]. Massachusetts: Massachusetts General Hospital; c2007-2012 [cited 2012 Oct 26]. Medical device 

"plug-and-play" interoperability program. Available from: http://www.mdpnp.org/about.html. 

53 24x7 [Internetj. California: Allied Media; [cited 2012 Oct 26]. AAMI and UL to develop interoperability standards. 

Available from: http://www.24x7mag.com/joltnews/2012-10-02_ 07.asp. 

54 Audet AMJ, Kenward K, Patel 5, and Joshi MS. Hospitals on the path to accountable care: highlights from a 2011 

national survey of hospital readiness to participate in an accountable care organization [Internet]. The Commonwealth 

Fund; 2012 Aug [Cited 2012 Oct 26j. Available from: http://www.commonwealthfund.org/Publications/lssueBriefs/2012/ Aug/Hospita Is-on-the-Path-to-Accountable-Care.aspx. 

55 American Hospital Association [Internet]. Health Forum; c2012 [updated 2012 Jan 3; cited 2012 Oct 25]. Fast facts on 

US hospitals. Available from: http://www.aha.org/research/rc/stat-studies/fast-facts.shtm!. 

The Value of Medical Device Interoperability 

West Health Institute 43 
67 

Mr. PITTS. Chair thanks the gentleman, and now recognizes Ms. 

Bechtel for 5 minutes for an opening statement. 

STATEMENT OF CHRISTINE BECHTEL 

Ms. BECHTEL. Good morning. I am Christine Bechtel with the 

National Partnership for Women and Families. We are a nonprofit, 

nonpartisan consumer advocacy organization. I also serve on the 

Federal Health IT Policy Committee. 

I am honored to speak today about how the EHR Incentive Program, commonly known as ‘‘Meaningful Use’’, is catalyzing fundamental change in our health care system and advancing innovation. 

Almost 3 years ago before this same subcommittee, I shared a 

story of Susan Crowson, and she is a family caregiver from Maryland, and she cared for her father, Pop. Pop was seeing five different doctors, taking three different prescription drugs, two overthe-counter drugs, and daily vitamins to manage a host of complex 

conditions, including Alzheimer’s Disease, and arrhythmia. Susan 

diligently tracked all of Pop’s medications, tests, lab results, and 

visits on a spreadsheet to help his doctors avoid medical errors and 

provide the best care possible in our highly fragmented system. 

Today, the Meaningful Use Program is making care better for 

people like Pop and caregivers like Susan. Providers with certified 

EHRs now maintain up-to-date electronic lists of patient’s health 

conditions, diagnoses, and medications, and doctors can automatically track for drug interactions and allergies. Pop and Susan can 

get a summary at every office visit so they know the diagnosis and 

the plan. If Pop is admitted to the hospital, they can send a summary of his admission to his primary care doctor. These are just 

some of the early innovations in health IT. 

Sadly, many of these advances were not put in place quickly 

enough to help the Crowson family. Since I last testified, Pop has 

passed away. But thanks to Meaningful Use, patients and family 

caregivers like Susan are less likely to face these same struggles. 

They are now coming to expect health IT, just as technology has 

revolutionized so many other aspects of our life. 

Indeed, the arc of adoption has surpassed our expectations. At 

the last subcommittee hearing in 2010, we wondered if incentive 

payments would be effective drivers of EHR adoption. We asked if 

providers would be able to achieve Meaningful Use. Federal officials then offered a high end estimate of 53 percent of office-based 

physicians would adopt EHRs by 2015. But as of this February, 2 

years before the 2015 projection, CMS reports that 40 percent of 

eligible professionals have already completed phase one of Meaningful Use, either in Medicare or Medicaid, and more than 70 percent have registered for it. Hospitals have been even more successful. Seventy percent are already Meaningful users, and 85 percent 

have registered. 

But there is much more work to do. To foster continued innovation, we must deploy a wider array of standards through HHS’s 

certification program, which has been essential to breaking down 

technical barriers to the secure sharing of health information. It is 

this federal leadership which occurs in collaboration with the private sector that is critical to innovation. 

68 

We also need new approaches to payment that moves us beyond 

fee-for-service and creative business case for care coordination and 

improved health outcomes. This can only be done by rewarding 

quality and value over volume. But we simply cannot measure and 

reward this kind of care without health IT. 

Even within these limitations, though, advancements in standardization spurred by the Meaningful Use regulations are catalyzing innovation. So for example, Medicare and the VA implemented a feature called Blue Button that allows individuals to securely view and download their health information online, and this 

innovation is making a world if difference for people like Beth 

Schindele, who cares for her father, William Graves. With his permission, Beth went to mymedicare.gov and downloaded his health 

information when he was in the hospital. The data from Blue Button showed that he had more than 63 providers caring for him over 

the course of four hospitalizations in the last year and a half, and 

she told me last week ‘‘Having the data in my hands during his 

hospitalization allowed me to prevent the hospital from erroneously 

placing him on Coumadin, which is a blood thinning medication, 

and he had stopped taking that 2 years ago. I am so thankful that 

I did. Within hours of discharge, he fell and he suffered severe 

head and arm lacerations that would have been life-threatening 

had he been on Coumadin, and would have resulted in a readmission within just 5 hours of leaving the hospital.’’ Blue Button is a 

simple, yet powerful, innovation that will help consumers play a 

critical role in promoting safer, more affordable, and more coordinated care. 

For this kind of innovation to accelerate, the challenge before us 

is to ensure that every provider in the country has health IT. We 

must expand the Meaningful Use program to connect other providers like long-term care, behavioral health, and home health. No 

other program in history has done this much this quickly to advance the adoption of health IT, and I am confident that along with 

payment reform, it will result in better care at a lower cost. Thank 

you. 

[The prepared statement of Ms. Bechtel follows:] 

69 


80806.014

national 

~~ partnership 

for women & families 

Good afternoon Mr. Chairman, Ranking Member Pallone and distinguished committee 

members. I am Christine Bechtel, vice president of the National Partnership for Women & 

Families, a non-profit, non-partisan consumer advocacy organization. For the last four 

years, I have also served on the federal Health IT Policy Committee as a consumer 

representative. 

With more than 40 years of experience working to make life better for women and families, 

the National Partnership promotes access to high quality health care, fairness in the 

workplace and policies that help women and men meet the dual demands of work and 

family. 

As you know, health care is central to the well-being of women and families - it is a key 

determinant of their quality of life, their economic security, and their ability to thrive, 

prosper and participate in our society. In collaboration with the consumer coalitions we 

lead, which include the Consumer Partnership for eHealth (CPeH) and the Campaign for 

Better Care, we are working to advance private and secure health information technology 

(IT) in ways that measurably improve the lives of individuals and their families. Advancing 

and using health IT is essential to making health care more accessible, affordable and 

effective for consumers because health IT is a tool that can empower consumers to work in 

partnership with professional care team members and make informed choices about 

treatment options. It has enormous potential to improve the quality of clinical care, 

decrease health disparities, and bolster research and public health. 

I am honored to be asked to speak with you today about how the Electronic Health Record 

(EHR) Incentive Program (commonly known as "Meaningful Use") is not only catalyzing a 

fundamental change in the health care system, but is serving as a springboard for 

innovation. 

Why Health IT Matters 

Almost three years ago in testimony before this subcommittee, I shared the story of Susan 

Crowson, a family caregiver from Maryland, who cares for her father "Pop". At that time, I 

described how Pop was seeing five different doctors - each of whom monitored and treated a 

separate problem - and was taking three prescription drugs, two over-the-counter drugs, 

occasional antibiotics, and daily vitamins to manage a host of complex health conditions 

including Alzheimer's disease and heart arrhythmia. Susan was his Coordinator in Chief, 

diligently tracking all of Pop's medications, tests, labs and doctor visits to help his doctors 

avoid medical errors and provide the best care possible in a highly fragmented system. It 

was a recipe for mistakes. 

Susan built her own spreadsheet to keep track of it all. She left copies with each doctor Pop 

saw, but the information never made it into their records. She always asked his doctors to 

1875 connecticut avenue, nw N suite 650 N washington, dc 20009 N phone: 202.986.2600 N fax: 202.986.2539 

email: info@natlonalpartnership.org N web: www.nationalpartnersilip.org 
70 


80806.015

share his record with the primary care physician and other specialists, but it was rarely 

done. When she took her dad for lab tests every two months, she was the one making sure 

each doctor got the results - or it didn't happen. When Pop's doctors would prescribe a new 

drug, they would tell Susan to check with Pop's other four doctors about potential drug 

interactions. 

The Meaningful Use program was designed with families like Susan's in mind. Today, the 

work she did to keep Pop safe from medical errors is getting easier because phase one of the 

Meaningful Use program: 

• Enables providers to maintain up-to-date electronic lists of the health conditions, 

diagnoses, medications, and medication allergies of patients like Pop. They can 

automatically: 

o Check for drug-drug interactions and drug-allergy problems; and 

o Send prescriptions electronically to Pop's pharmacy of choice, reducing wait 

time and eliminating handwriting errors. 

• Facilitates communication with patients and other providers, including sharing 

information that provides a more complete picture of a patient's health. 

o For the Crowsons, this would mean Pop and Susan get a summary of every 

office visit so they know what was diagnosed and what the plan is. 

o Any of Pop's five doctors can send a summary of his record securely to other 

members of his care team who are Meaningful Users. 

o If Pop is admitted to an EHR-enabled hospital, they can send a Summary 

Care Record to his primary care doctor once he's discharged. 

• Helps caregivers like Susan easily and conveniently access medical records online 

and send a secure email to his providers. 

I must tell you, sadly, that many of these advances were not put in place quickly enough to 

help the Crowsons. Since I last testified before this subcom~ittee, Pop has passed away but 

Susan's heroic work to keep him safe from medical errors and get him high quality care 

continued to the end of his life. However, because of Meaningful Use, other family 

caregivers will not face the same overwhelming struggles. In just two years since 

Meaningful Use was put in place, the experiences and expectations of patients and families 

are changing dramatically, and these benefits will accelerate as the incentive program 

continues. 

This, I am convinced, is why EHR adoption must become universal. 

How Far We've Come 

At the last subcommittee hearing in 2010, we discussed and debated this program's 

potential. We wondered if incentive payments would be effective drivers of EHR adoption. 

We asked whether Eligible Professionals (EPs) would be able to achieve Meaningful Use. 

Centers for Medicare and Medicaid Services officials projected a high-end estimate that 53 

percent of ambulatory care providers would adopt EHRs by 2015. 
71 


80806.016

But as of February of this year - two years before the 2015 deadline - CMS data show that 

more than 70 percent of eligible providers (370,000) have already registered for the 

program, signaling their intent to complete it. And nearly 40 percent have already 

successfully completed the first phase of either the Medicare or Medicaid incentive 

program. 

Hospitals have been even more successfuL Almost 85 percent of Eligible Hospitals have 

registered for the program and more than 70 percent are meaningful users today. 

These data underscore how the investment Congress made in health IT is helping families 

like Susan Crowson's and patients like Pop. The incentive payments are accelerating the 

arc of adoption well beyond what we anticipated, and that means patients and families are 

beginning to reap the benefits of these reforms. We are coming to expect the presence of 

health IT to optimize our health and health care, just as technology has revolutionized so 

many other aspects of our lives. 

Yet we have a ways to go. We all agree that the health care system must change. Despite 

the best efforts of deeply caring health professionals, our health care system is simply too 

expensive in both financial and human terms - for patients and providers alike. While the 

United States is home to the best doctors, clinicians and treatments in the world, the kind 

of coordination and communication that patients and families want and need is discouraged 

by our fee-far-service payment system. 

Many of our best ideas to change the way we pay for and deliver care - Accountable Care 

Organizations, Patient-Centered Medical Homes, bundled payments, and others -

absolutely hinge on the availability and seamless exchange of health information to 

introduce efficiencies and cost savings, and to provide the kind of care that improves 

patients' health. They require measuring and rewarding value and quality over volume. 

But we simply cannot measure health outcomes or efficiency without health IT. We need 

clinical data from the point of care - not just billing data - to provide a complete picture of 

a patient's health and to accurately assess and pay only for care that is effective, efficient 

and equitable. 

In other words, health IT is an important engine that can drive improvement and 

innovation in health care, and the Meaningful Use program is its primary fuel. 

An Engine for Innovation 

In only its first phase, this program has achieved a tremendous amount. There is certainly 

work remaining, and I believe this work will bear the fruit of remarkable innovation once 

two things happen: 

• First, when a wider array of standards are deployed through the Department of 

Health and Human Services' (HHS) Certification program (which stipulates the 

technical specifications ofEHRs qualified for the incentive program) and Meaningful 

Use requirements for data sharing. More robust standards would foster information 

sharing across more participants in the system, including with non-Meaningful Use 
72 


80806.017

eligible providers like nursing homes. Standards can also help connect medical 

devices to EHRs. 

• Second, as new approaches to payment and delivery are expanded and begin to 

create the business case for care coordination and improved health outcomes. This 

will, in turn, drive the creation of innovative tools that foster information sharingmaking the right thing to do the easy thing to do. 

We have been slow to develop the battery of standards and services needed to make care 

coordination across health systems easy and efficient for both providers and patients. While 

experts have been working for decades to create standards and drive their adoption in the 

private sector, these well-intentioned efforts have been plagued by a maze of competing 

standards in some areas, and a complete lack of standards in others. 

The Meaningful Use regulations and complementary Certification rules have been essential 

to cutting through the noise and enabling health information to be more uniformly collected 

and shared. This kind of federal leadership, which occurs in collaboration with the private 

sector in open and transparent ways, is critical to fostering innovation. 

Already, though, advancements in standardization generated by the Meaningful Use and 

Certification regulations are catalyzing innovation for providers, patients and families. For 

example, the proportion of hospitals electronically exchanging clinical summaries with 

outside hospitals tripled between 2008 and 2012. The Office of the National Coordinator for 

Health Information Technology (ONC) has also funded several advanced research projects 

that leverage the standards ofEHRs. An example is the SMART platform, which is an open 

way that individual patients, physicians, small software vendors and others can design 

innovative health IT applications at a lower cost, using an approach that is not unlike 

developing an iPad app today. 

For consumers, Medicare and the Veterans Administration have implemented a 

standardized feature called Blue Button that allows beneficiaries and veterans to view and 

download their own health information online. The information from Medicare is based only 

on claims data, but beginning in January, the Meaningful Use program will include this 

capability for all eligible providers and hospitals. 

This innovation makes a world of difference for people like Beth Schindele, who cares for 

her father, William Graves. With his permission, Beth went to MyMedicare.gov and 

downloaded her father's health information while he was hospitalized. She found an app 

that could upload and display her father's Blue Button information in understandable and 

useful ways. She told me just last week: 

I cannot even begin to explain how access to my father's data has impacted the coordination 

of his care and improved his life. The data from Blue Button revealed that he had more than 

63 providers caring for him during four hospitalizations in the past 1.5 years. Blue Button 

showed me his current medications, diagnoses, procedures, providers and preventive services 

needed as well as hospitalizations. Without access to his data, at the point of care, I would 

not have been able to coordinate his care, and reconcile his medications with his care 

team. Having the data in my hands during his hospitalization allowed me to have 

intelligent conversations with his care team and prevent them from erroneously placing him 
73 


80806.018

on a medication he had stopped taking two years ago - and I am so thankful that I was able 

to do so. 

The hospital had an old record showing he had a diagnosis that required him to take 

Coumadin, which is a blood thinner. And because I had the [Blue Button} data in my hands, 

I could show them that he was no longer on that medication, and that truly was 

instrumental in saving his life. Within hours of his discharge he fell and suffered severe 

head and arm lacerations that would have been life threatening had he been on Coumadin 

and would have resulted in a readmission within just five hours of discharge. 

Beth's story reminds us that it is absolutely critical that health IT systems enable providers 

to safely and securely share information, not just with each other but with patients and 

families -a very meaningful innovation. We cannot rely solely on clinicians to detect errors 

in such a complex system, no matter how hard-working and dedicated they may be. The 

Blue Button functionality will help consumers playa crucial role in promoting safer care, 

which in turn will lower costs. And Blue Button will be part of the Meaningful Use program 

next year, which will provide clinical data from EHRs. 

This innovation would not have happened without the leadership of Medicare, the VA, and 

the Office of the National Coordinator in collaboration with private sector innovators. 

Bolster and Expand Meaningful Use 

The ~h~ilengeb~fore us is how to ensure everYp~~~d.er in the co~~t~yh;;:sh~~lthIT th;ti~ 

capable of safely and securely measuring the quality of care, coordinating with other 

providers, and giving patients and family caregivers the information they need to be active 

partners in care and in health. 

We have made remarkable progress already. We must expand the Meaningful Use 

program, both by advancing its requirements and standards and by extending incentive 

payments to other, non-eligible providers, such as long-term care, behavioral care, and 

home-based care. 

We all know that how best to fix our health care system has become one of the most 

contentious issues of our time. But there is no disagreement that we need a more efficient, 

effective system that provides higher quality care for our sickest and most complex patients 

at lower costs, and reduces the burden on family caregivers. We now have a track record 

that demonstrates that Meaningful Use is a critical piece of the way forward. Thank you 

for the opportunity to testifY here today. 
74 

Mr. PITTS. Chair thanks the gentlelady and now recognizes Mr. 

Bialick for 5 minutes for an opening statement. 

STATEMENT OF JIM BIALICK 

Mr. BIALICK. Chairman Pitts, Ranking Member Pallone, members of the subcommittee, thank you for the opportunity to testify 

on this important issue. And thank you, Mr. Pitts, for the promotion, but I am actually the Executive Director of the Newborn 

Coalition. We are an all volunteer organization that came together 

to promote the development and use of mobile apps and technology 

in newborn and infant health. 

The catalyst for our beginning was the birth of a baby named 

Eve, who at 40 hours old was diagnosed with a critical congenital 

heart defect, the most common birth defect in the U.S. affecting 

nearly 1 in 100 births. Had it not been for an attentive nurse, Eve 

would have been discharged with a partially formed heart. While 

a simple screening tool, pulse oximetry, exists to identify these conditions, there is still no national requirement for routine screening. 

Her mother, our co-founder, started a crusade to ensure that babies 

like Eve would never again be sent home without first being 

screened. 

We estimate that since our efforts began, the number of babies 

screened for heart defects in the U.S. has increased by 4,500 percent. To date, we have aided in the drafting of legislation in 23 

States and the enactment of nine laws. The first was in New Jersey, where a baby was identified with a heart defect before a discharge on the very first day of screening, and most recently, in 

California. 

We are very proud of these numbers, but we have learned that 

it is not enough just to screen, but we also have an obligation to 

accommodate the lifelong needs of those diagnosed by the screening, and consumer technology, such as mobile apps, play an important role in fulfilling that responsibility. 

It is important to remember that of the more than four million 

babies born in the U.S. every year, the majority aren’t born in advanced cardiac surgery centers. They may be sent to several hospitals, be seen by more than a few doctors, be given a number of 

medications, which in today’s less than interoperable health care 

system means mom and dad will be responsible for managing and 

reconciling most of this information on the best and worst day of 

their lives. 

After leaving the hospital, babies can be monitored continuously 

from home using a pulse oximeter. These babies are special because they have heart defects, but they are still just babies and 

their parents are still exhausted. So what do parents do? They use 

the same smartphone or tablet that they use to manage all of their 

other important information. Families and providers have come to 

rely on mobile apps to allow them to capture readings from remote 

monitoring devices. This means less time having to focus on being 

a nurse and more time available to be a parent. 

The availability of these technologies has created a revolution in 

how we interact with our data and engage in our health, but it has 

also created legitimate safety concerns that must be addressed. 

However, the FDA draft guidance as written would seemingly atVerDate Nov 24 2008 13:42 Sep 13, 2013 Jkt 037690 PO 00000 Frm 00080 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-21 CHRIS
75 

tempt to regulate the future of health care technology as a standalone medical device. In my written testimony, I have laid out a 

model for a risk-based framework that very intentionally delineates 

between health information management apps and actual medical 

devices. 

Applications and the platforms that support them have the ability to integrate and interoperate with any device that will allow it. 

Consumer demand for integrated technology solutions will drive 

the market to a wholly interoperable system that can be accessed 

at any time, anywhere, and by any device, and we would be foolish 

to believe that this integration will happen and will not include 

health information. 

Consumer technologies have evolved to leverage the Internet to 

share data, including with medical devices, functionally eliminating 

the difference between being on a network and physically linking 

devices with a cord. As a result, we need to be thinking about the 

regulation of technology differently. What we need is a new patient-centered risk-based regulatory framework for evaluating 

health technologies that is flexible enough to regulate what we are 

using today and adaptive enough to accommodate the technologies 

that have yet to be conceived. 

I know the concept of a new regulatory process is daunting, but 

an existing framework does not create the certainty that the 

emerging health care technology marketplace needs to flourish. I 

cringe when I hear from patient organizations that are dedicating 

a significant amount of their budget to develop a mobile app, because I know their product may have to go through a process that 

would cost them more than they can afford, rendering their initial 

investment worthless. I was disheartened when my wife, who is 

now 4 months pregnant, asked me which app she should use to 

track her pregnancy. I told her the one with the fewest, least complex features, because I wanted to make sure that she didn’t lose 

all the data that she would enter throughout the pregnancy in the 

event the manufacturer depreciated certain functionalities to avoid 

the FDA. To me, that is not certainty and that is not pro-patient. 

This committee has the foresight to hold—has had the foresight 

to hold this hearing because collectively, you recognize that mobile 

apps are transforming how patients, families, and providers engage 

in the delivery of health care. Reform will not be without controversy, but it is far better to address this issue now than to wait 

for traditional approaches to fail at the expense of patients and 

families. 

Thank you again for this opportunity to testify. I look forward to 

working with you on this important issue, and I am happy to answer any questions. 

[The prepared statement of Mr. Bialick follows:] 

76 


80806.019

newborn 

Testimony of Jim Bialick 

Executive Director, Newborn Coalition 

To the Energy and Commerce Committee 

Subcommittee on Health 

March 20,2013 
77 


80806.020

Chairman Pitts and Raking Member Pallone, Members of the Subcommittee, thank you for the 

opportunity to testify on this very important issue. My name is Jim Bialick and I am the 

Executive Director and co-founder of the Newborn Coalition. The Newborn Coalition is an allvolunteer organization that came together to promote the development and use of technology in 

newborn and infant health. 

Why We Started 

The catalyst for our beginning was the birth of a baby named Eve in Minnesota who, at 40 hours 

old, was diagnosed with a critical congenital heart defect. Congenital heart defects are the most 

common birth defect in the U.S., affecting nearly I in 100 births. While a simple screening tool, 

pulse oximetry, exists to identify these conditions, there still is no national requirement for 

routine screening. 

Had it not been for an attentive nurse that went the extra mile, Eve would have been sent home 

missing part of her heart. After Eve's recovery from two open-heart surgeries, her mother - our 

co-founder- started a crusade to prod law makers, regulators and health plans to adopt 

technology to advance newborn screening for heart defects. We want to make sure that babies 

like Eve are never sent home without first being screened. 

Screening Newborns for Heart Defects 

Our ongoing work includes the nationwide implementation of heart disease screening through 

the pursuit of state legislation. To date, we have aided in the drafting oflegislation in 23 states 

and the enactment of 9 laws. The first was in New Jersey where a baby with a hypoplastic left 

heart syndrome was identified before discharge on the very first day screening was required by 

law. The most recent law was enacted in California last year, the state where my wife and I 

grew up and where our parents want us to return and have newborns of our own. 

We estimate that since our efforts began, the number of babies screened for heart defects in the 

U.S. has increased nearly 4,500%. We are very proud of these numbers because we can be 

confident that more little Americans will go on to live happy and healthy lives. It also gives us 

hope that healthy babies remain a bipartisan issue. 

Technology Helps Babies, Parents, Health Care 

As our efforts progress nationwide, we have learned that screening babies for heart defects is not 

where our jobs end, but rather where they begin. It is not enough just to screen, but we also have 

a responsibility to accommodate the short term and long-term follow-up needs of those 

diagnosed by the screening. 

There are often very different clinical paths families of a baby diagnosed with a heart defect may 

take: sometimes this includes at-home monitoring, follow-up imaging to diagnose the defect, or 

maybe it means emergency surgery to correct an imperfect heart that is trying to sustain an 

otherwise healthy little baby. 
78 


80806.021

It is important to remember that of the more than 4 million babies born in the US every year, not 

all of them are born in advanced cardiac surgery centers. They may have been to several 

hospitals, been seen by more that a few doctors, and been given a number of medications, which 

in today's less-than-interoperable healthcare system, means mom and dad will likely be 

responsible for managing and reconciling most of this information on what is likely the best and 

worst day of their lives. 

So what do parent's do? They rely on what they know and use every day: the same smartphone 

or tablet that they use to manage all of their other important information. And why not? There 

are more than 97,000 medical applications available in the iOS app store alone. 

Because the clinical journey will be different for every baby, we often hear from our network of 

parent advocates that they are using one or more mobile apps to stay on top of their baby's health 

information in order to keep their baby's health at the center of his or her ongoing care. 

There are apps available that allow parents to access online services such as personal health 

records to document procedures their baby has undergone and drugs that their baby has been 

given. In other cases, newborns will be released from the hospital and monitored using a pulse 

oximeter from home. These babies are special because they have heart defects but they are still, 

just babies and their parents, are still exhausted. Many families have come to rely on mobile 

applications that allow them to capture readings from home monitoring devices so they may 

easily share them with a provider. This means less time having to focus on being a nurse and 

more time available to be a parent. 

Technology Is Transforming Care and Culture 

Be it patients, families, or providers, broad-based demand for information technology in 

healthcare has fostered a creative and innovative market that is has evolved to address the many 

needs of a diverse consumer population. With this evolution in engineering has come an equal 

progression in our culture. We are not only demanding more from our applications and devices, 

but also that the information we manage be platform agnostic and work on our phones, tablets, 

and PCs identically. 

This demand is coming from patients and families as well as providers. A full 62 percent of 

providers have begun using tablets to deliver care; that number is up 27 percent from only a year 

ago. Families are using these tools, why shouldn't providers use the ofmHealth apps designed 

specifically for them? The families that we work with want their devices to connect directly to 

what their doctor is using so that they can know the instant something changes with their baby's 

health. 

As mobile technologies advance, clinicians and entrepreneurs have developed applications to 

address increasingly complex healthcare and data management issues. While the availability of 

these technologies has created a revolution in how we interact with our data and engage in our 

health, it has also created legitimate safety concerns that must be addressed. 
79 


80806.022

Mobile Apps Are Not Medical Devices 

Most medical apps are not medical devices as most understand that term and regulating mobile 

apps as such does not make sense. Mobile apps are developed and sold in a dynamic 

marketplace: estimates indicate that the number of smartphone consumers using medical apps 

will grow to 500 million by 2015. 

That's why we were so surprised when the FDA issued a draft guidance to regulate mHealth apps 

as medical devices in 2011. Even then it seemed like the definition the FDA was using for a 

"mobile medical app" was outdated. Cloud computing has enabled us to access incredibly 

innovative and powerful software with the click of a mouse or the tap of a touchscreen. Mobile 

apps can no longer be considered discreet pieces of software that reside on a specific device; the 

cloud has allowed us to access a myriad of programs through a single app: our Internet browser. 

The traditional process for approving and regulating health technologies is not nimble enough to 

appropriately scale or keep pace with its unprecedented expansion. While the Food and Drug 

Administration (FDA) has a legitimate role to play in maintaining patient safety for the highest 

risk products, it is readily apparent that Congress can and should adopt a more flexible model for 

products that simply manage information. In addition, sequestration is a political reality that has 

certainly impacted FDA's in-house expertise available to manage a broad range of products. A 

concern shared by many is whether FDA possesses the manpower and expertise, as well as 

whether the regulatory science has been fully developed to take on regulation of the mobile 

medical app market. Many shared these concerns even before sequestration took effect. 

Fqrthermore, the existing FDA structure for regulating medical devices was conceived in an era 

where personal computing was in its infancy and adoption of consumer technologies in 

healthcare was nearly non-existent. The device approval process (510(k)) was implemented 

when our ability to share data was limited to what we could fit on a 5 V. inch floppy disk. Why 

then, do we believe that the approval process will be flexible enough to accommodate the future 

of multi-function technology and a software market that we literally cannot imagine? The 

Institute of Medicine put it best in its 2012 report, Health IT and Patient Safety: Building Safer 

Systems for Better Care: "The current FDA framework is oriented toward conventional, out-ofthe-box, turnkey devices." 

Applications, and the platforms that support them, have the ability to integrate and interoperate 

with any device that will allow it. At a point we must assume that increased connectivity 

between networks will make mobile device data -and what we consider as more traditional 

data-indistinguishable. Consumer demand for integrated technology solutions will drive the 

market to a wholly interoperable system that can be accessed at any time, anywhere, and by any 

device. We are fooling ourselves if we think this revolution will not include health information. 

App developers are concerned-and absent change, should continue to be concerned-that their 

products will be subject to new or additional regulation by a system designed for products that 

are not information or health management systems. Congress should be concerned that the 

creativity and innovation that is helping patients and parents may evaporate under wellintentioned, but ill-conceived regulations. 
80 


80806.023

Towards a New Framework: Patient Safety and Innovation 

As a result, we need to be thinking about regulating technology differently. What we need is a 

new framework for evaluating health technologies that can scale to effectively regulate what we 

are using today, and anticipate technologies yet to be conceived. 

A new framework that accounts for data sharing, innovation and patient safety is important to 

help ensure patients have access to safe and helpful technologies. Patient safety and innovation 

are not mutually exclusive; they are complementary concepts in a system that clearly lays out the 

rules of the road. Congress should reevaluate the current process, including FDA's draft 

guidance on mobile applications, and pass legislation to promote safety and advance innovation. 

The Newborn Coalition believes such a system should include the following principles: 

1. Regulations should evaluate technologies and their functionality as designed. To promote 

competition and job creation, manufacturers and end-users (consumers and healthcare 

providers) need clarity about the rules and requirements of the regulatory process. 

Regulators and end users need guarantees that a product will function as designed. We 

believe the approach to regulating health information systems must be scientific and 

based on testable consensus-based standards. 

2. Regulatory structures should evaluate technology based on risk and according to 

standards. Products and their level of regulation should be categorized by risk. Risk is 

determined by the potential for variability in the health information system's operation or 

a system's ability to function ad infinitum: meaning that it is able to generate a response 

within an expected range regardless of input. FDA should evaluate the highest risk 

products. Private certifiers with expertise in software design and testing and contracted 

to the federal government, should evaluate lower risk products. 

3. Standards should incentivize safer products through market signals. Software and 

devices developed in accordance with consensus-based standards are more predictable 

and therefore safer. We suggest creating a process to standardize the assessment of risk 

and create incentives for developers to create products that conform to standards. 

4. Products should be evaluated by those with the best expertise and experience. 

Regulatory bottlenecks can be addressed by implementing a process similar to the Office 

of the National Coordinator's (ONC) approach in certiJYing Electronic Health Record 

(EHR) systems and EHR modules for use in the Meaningful Use Program through 

accredited industry certifiers. Congress might authorize private certifiers to affirm 

mobile apps do what they say they can do. In light of the significant regulatory science 

demands entailed in certiJYing an array of technologies, ONC, in its Permanent 

Certification Program, created a process for Standards Development Organizations 

(SDOs) and private industry, to accredit certifiers for the program. Such an accreditation 

process will help ensure credible, unbiased certifiers for mobile apps. 

It is important to note, the FDA has an important role to play in this regulatory framework, but 
81 


80806.024

that role should be reevaluated based on what is best for patients, parents, and providers. We 

must be thinking about how this consolidated information network will interact with medical 

devices that are currently FDA regulated. If consumer technologies are all sharing data across a 

common network, including with medical devices, then do all technologies on the network 

become accessories to those regulated medical devices? Will they need to be regulated 

themselves? 

The old adage rings true: you are only as strong as your weakest link. In the era of connected 

health, the biggest danger to patient safety is being unable to determine where the weak link is. 

To combat this threat, we must change our thinking from categorically regulating technologies 

that may be used in health care, to evaluating them based on the risk they have of not functioning 

as designed. 

To move away from regulation by categorization we must focus on how these applications have 

been engineered. Do they comply with a known standard for a given functionality? Is there a 

way to test that a technology will function as designed? If the answer to these questions is yes, 

than the software or device is more predictable and therefore poses lower-risk to the end-user. 

I know that the concept of a new regulatory framework designed to encourage innovation in the 

marketplace is daunting to some, but another question we must ask ourselves is: will using a 

process that was conceived in a different era that is already overburdened by backlog going to 

create more certainty or will it raise more questions? 

Regulatory Policy Has a Real Impact on Patients 

I cringe when I hear from patient organizations that are dedicating a significant amount of their 

budget to developing a mobile medical app for their community because I know that there is a 

potential that their product is going to have to go through a process that is going to cost them a 

great deal of money that they don't have, rendering their initial investment worthless. 

I worry when I hear from Medicaid providers that are telling their patients to engage in their 

health through free apps. If apps are medical devices, are they then subject to the 2.3 percent 

medical device tax? If so, will those apps continue to be free? 

And I was disheartened when my wife, who is now four months pregnant, asked me which 

mobile medical app she should use to track her pregnancy. My gut reaction was to say: the one 

with the fewest, least-complex features, because I wanted to make sure that she didn't lose all of 

the data that she would enter throughout the pregnancy in the event that the app was pulled off of 

the market if FDA advanced their final regulation. I was also concerned the manufacturer might 

depreciate certain functionalities related to the app to avoid potential regulation. 

This feels like the opposite of certainty to me. It is definitely not pro-patient. 

This Committee has had the foresight to hold this hearing because collectively you recognize that 

mobile apps have the capacity to transform how patients, families, and providers engage in the 

delivery of health care. Congress has a tremendous opportunity to intervene, here and now 
82 


80806.025

before this vibrant and robust market is thrust into an ill equipped regulatory process. Reform of 

this magnitude will not be without some controversy and growing pains, but it is far better to 

address this issue now then to wait for traditional approaches to fail. Inaction is something we 

simply cannot afford. 

Thank you again for this opportunity to testify. I look forward to working with you on this 

important issue and I am happy to answer any questions. 
83 

Mr. PITTS. Chair thanks the gentleman, and now recognizes Dr. 

Mitus for 5 minutes for an opening statement. 

STATEMENT OF JACQUELINE MITUS 

Dr. MITUS. Good morning, Mr. Chairman and distinguished 

members of the subcommittee. My name is Jackie Mitus, and I currently serve as Senior Vice President of Clinical Development and 

Strategy for McKesson Health Solutions. I appreciate the opportunity to appear before you today. 

My background as a practicing hematologist/oncologist at the 

Brigham and Women’s Hospital in Boston, and faculty member of 

Harvard Medical School, as well as my responsibilities at 

McKesson, have provided me with a unique perspective on health 

information technology. I have seen first-hand how critical health 

IT is to advancing the care and safety of patients. 

As the largest health IT company in the world, McKesson has actively engaged in the transformation of health care from a system 

burdened by paper to one empowered by interoperable electronic 

solutions. 

I would like to make two key points today. 

First, health IT is foundational to improving the quality, safety 

and affordability of healthcare. 

Second, to ensure continued innovation and leverage the power 

of health IT, we need a new regulatory framework that is riskbased and specific to health IT. 

Health care in our country is undergoing fundamental changes 

to make it safer, better, and more efficient. Health IT is the foundation of these efforts. It provides access to current, accurate patient information such as medication history, and it supports the 

clinician in preventing errors, identifying gaps in care, and suggesting appropriate diagnostic and treatment paths. Health IT does 

not replace physician judgment, but rather, provides guidance and 

support. The ultimate responsibility for the care and safety of a patient always rests with the treating clinician. 

Today, the FDA has authority to regulate medical devices under 

amendments to the Food, Drug, and Cosmetic Act adopted in 1976. 

The definition of a medical device in the Act is broad and can be 

interpreted to include all health IT, including medical software. 

The current regulatory approach for medical devices, however, is 

not well-suited for health IT. For example, does an iPad that reminds a patient to refill a prescription make it a traditional medical device? What about an application that allows a clinician to access a medical journal or review an x-ray online? Should these applications and the iPad each be subject to FDA regulations? 

Medical software is fundamentally different from medical devices 

in two important ways. First, the safety of a medical device is almost entirely dependent upon how it is manufactured. The safety 

of health IT, on the other hand, hinges upon how it is developed 

and perhaps more importantly, on how it is implemented. Thus, 

health IT cannot safely be ensured simply through good manufacturing practice. 

Second, medical devices, unlike health IT, are directly involved 

in the treatment of a patient with little, if any, opportunity for a 

clinician to intervene. The majority of medical software does not diVerDate Nov 24 2008 13:42 Sep 13, 2013 Jkt 037690 PO 00000 Frm 00089 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-21 CHRIS
84 

rectly or independently act upon a patient, but rather, provides 

data and guidance. The ability of a learned intermediary to utilize 

professional judgment distinguishes this technology from traditional medical devices. 

Mr. Chairman, we risk using a law enacted nearly a half century 

ago to regulate a rapidly changing and dynamic era of technology. 

In closing, I would like to highlight the work of the Bipartisan 

Policy Center, BPC, which last month released a report in response 

to the FDA Safety and Innovation Act. With the input of nearly 

100 organizations, including McKesson, the BPC recommended dividing health IT into three risk categories. The first and highest 

risk category includes technology linked to or used to operate a 

medical device. This technology would continue to be regulated as 

a medical device. The second category includes medical software 

that merely guides the physician, such as clinical decision support 

or electronic health records. This group would be subject to rigorous accreditation by an independent third party, or perhaps 

ONC. Finally, the third category, non-clinical technology, such as 

billing and scheduling software, would not be subject to regulatory 

oversight. The BPC approach is flexible, protects patient safety, 

promotes innovation, and leverages existing quality and safety 

standards. 

In conclusion, health IT is imperative to the successful transformation of health care. It improves the quality of patient safety, 

enables payment and delivery reform, and promotes efficiency and 

lower cost. That is why it is so important that we regulate health 

IT thoughtfully to advance care and support innovation. That is 

why we need a new risk-based framework such as that proposed 

by the BPC. 

On behalf of McKesson, I thank you for the opportunity to share 

our thoughts. 

[The prepared statement of Dr. Mitus follows:] 

85 


80806.026

STATEMENT OF 

A. JACQUELINE MITUS, MD 

SENIOR VICE PRESIDENT, CLINICAL DEVELOPMENT AND STRATEGY 

McKESSON HEALTH SOLUTIONS 

BEFORE THE 

ENERGY AND COMMERCE SUBCOMMITTEE ON HEALTH 

U.S. HOUSE OF REPRESENTATIVES 

HEALTH INFORMATION TECHNOLOGIES: How INNOVATION BENEFITS PATIENTS 

MARCH 20, 2013 

Good morning Chairman Pitts, Ranking Member Pallone and distinguished members of the 

Subcommittee. My name is Jackie Mitus, and I currently serve as Senior Vice President of 

Clinical Development and Strategy for McKesson Health Solutions. I appreciate the opportunity 

to appear before you today. 

My background as a practicing hematologist/oncologist at the Brigham and Women's Hospital in 

Boston, and faculty member of Harvard Medical School, as well as my responsibilities at 

McKesson, have provided me with a unique perspective on health information technology (IT). I 

have seen first-hand the value that health IT brings to patient care as well as the overriding 

importance of protecting patient safety. 

I work every day on the development and deployment of health information technology 

solutions that improve the quality and safety of patient care. I am pleased to share with you 

McKesson's perspective on the benefits and value of health IT and to discuss the need to 

establish a new regulatory framework for medical software. 
86 


80806.027

For 180 years, McKesson has led the industry in the delivery of medicines and healthcare 

products. McKesson is the nation's largest distributor of pharmaceuticals, and we pride 

ourselves on the efficiencies that we bring to the healthcare system by delivering safe medicines 

every day to pharmacies, hospitals, physician offices, skilled nursing facilities and government 

locations, including every Department of Veterans' Affairs facility, across the country. 

As the largest health IT company in the world, McKesson has decades of experience serving the 

health IT needs of the largest and most diverse provider base in the industry, including 50 

percent of all health systems, 77 percent of health systems with more than 200 beds, 20 

percent of all physician practices and 25 percent of home care agencies, which support more 

than 50,000 home care visits annually. We process billions of financial healthcare transactions 

annually among physicians, hospitals, pharmacies, insurers and financial institutions, and 

provide care and claims management solutions to most of America's health insurance 

companies. In short, we are actively engaged in the transformation of healthcare from a system 

burdened by paper to one empowered by interoperable electronic solutions that improve 

patient safety, reduce the cost and variability of care and advance healthcare efficiency. 

Based on this breadth of experience, I would like to make two key points to you and members 

of the subcommittee. 

First, health IT is foundational to improving the quality, safety and affordability of healthcare. 

Second, to ensure continued innovation in the development of health IT solutions and leverage 

the power of those solutions to transform healthcare, we need a new risk-based regulatory 

framework that is specific to health IT. 
87 


80806.028

Let me touch briefly on each of these points. 

HEALTH IT: THE FOUNDATION FOR CHANGE AND IMPROVEMENT 

Healthcare in our country is undergoing fundamental changes. Each day, clinicians and others 

critical to providing healthcare services strive to find safer, better, more efficient and 

increasingly patient centric ways to deliver care. Health IT is the foundation of these efforts. 

First and foremost, health IT underpins our ability to dramatically improve quality and safety. 

Physicians, nurses, pharmacists, paramedics and all health professionals increasingly rely on 

health IT systems in virtually all care settings. In order to provide safe, effective care, physicians 

must have timely access to current, accurate patient information, including medical history, 

medication lists, laboratory and x-ray results, regardless of location. Automating paper records 

and enabling electronic connectivity is critical to communicating and coordinating across 

dispa rate healthcare systems. 

Medical software can also help to inform physicians and other clinicians as they assess and treat 

patients. New advances in clinical care and other important information from text books and 

medical journals are made readily available through health IT. Additionally, automated clinical 

systems can help prevent medication errors, identify gaps in care, and suggest appropriate 

diagnostic and treatment paths. 

It is important to note that health IT does not replace physician judgment. Rather, it provides 

guidance and support by making patient data more readily available, and by automating clinical 

recommendations. The ultimate responsibility for patient treatment decisions and clinical care 

rests with the prescribing physician and his or her experience and expertise, along with other 
88 


80806.029

involved clinicians. I will come back to this in a moment when we talk about the differences 

between medical devices and health IT. 

Beyond improving quality and safety, health IT is also critical to transforming the way we deliver 

and pay for healthcare: transitioning from a volume system that rewards the number of tests or 

procedures performed to a value system that measures the quality of patient outcomes. 

Through data and analytics, transaction processing and cost transparency, health IT provides 

efficiency and support for delivery and payment reforms. With the adoption of Electronic 

Health Records (EHRs) and other health IT solutions by both physicians and hospitals, the 

market has now reached a tipping point where widespread interoperability could make possible 

the meaningful exchange of information to lower costs and support outcome-based health 

initiatives. 

Clearly, there is still much work to be done to improve health IT. In particular, the health IT 

industry is engaged in a new alliance to dramatically improve interoperability so that different 

health IT systems will be able to communicate with one another seamlessly. Earlier this month, 

McKesson and four other health IT developers announced their intent to form The 

CommonWell Health Alliance and their plans for CommonWeli to be an independent not-forprofit organization open to all health information technology vendors. The Alliance plans to 

promote and certify a national infrastructure with common standards and policies, which 

enable patient matching and linking services, HIPAA-compliant patient consent and access 

management, and a patient record locator and query service. These capabilities will allow care 
89 


80806.030

providers to more easily track and manage patients across disparate locations and to share 

critical information in an industry standard way. 

This effort and many others are ongoing. In the coming weeks, months and years, the pace of 

innovation in health IT will only increase, and, with it, the promise of improved care. 

A NEW RISK-BASED REGULATORY FRAMEWORK FOR HEALTH IT 

Now let me turn my attention to the need for a new risk-based regulatory framework for health 

IT. Given that health IT is critical to improving healthcare, and ever mindful of the incredible 

pace of innovation in technology development, it is imperative that health IT is regulated in a 

way that improves quality, assures patient safety and fosters innovation. 

Today, the Food and Drug Administration (FDA) has the authority to regulate medical devices 

under amendments to the Food, Drug and Cosmetic Act that were made in 1976. The definition 

of medical device in the Act is broad and can be interpreted to include all health IT, including 

medical software. 

The current regulatory approach for medical devices is generally not well-suited for health IT for 

three specific reasons. 

First, the drafters of the law defined medical devices based on the technology available at the 

time. No one could have envisioned the progress we would make in the development and 

implementation of technology in the almost 40 years since that definition was enacted. 
90 


80806.031

For example, does an iPad application to help track the number of steps walked per day, or a 

reminder that it's time to refill a prescription, render this apparatus a traditional "medical 

device"? Should each application upgrade require a regulatory review? 

Should the software that allows a physician to search a medical textbook or review x-rays online be subject to FDA regulation? That software merely provides access to medical data; it 

does not interpret or act upon the information that is transmitted. 

Should clinical decision support software that simply aggregates existing protocols and 

standards of care be regulated differently than those same standards that appear in printed 

form and sit on a shelf in the doctor's office? The information is exactly the same; the only 

difference is that the paper information is now automated and relayed to the physician in a 

different, more efficient format. 

The second reason for a new framework is that there are fundamental differences between 

medical devices and health IT. For example, safety of medical devices is almost entirely 

dependent on how they are manufactured. The FDA oversees the manufacturing, production 

and quality control processes of medical devices where problems might develop. 

Safety of health IT systems, on the other hand, is dependent on how they are designed and 

developed, and, perhaps more importantly, how they are customized, implemented and used. 

Safety in health IT, therefore, cannot be ensured simply through good manufacturing practices. 

Instead, it must be a shared responsibility among those who develop the technology, those who 

implement it, and ultimately those who use it. 
91 


80806.032

Finally, medical devices, unlike health IT, are directly involved in the treatment of a patient, 

with little if any opportunity for the clinician to intervene. Heart stents, implantable 

defibrillators and pacemakers all connect to the heart and function automatically without 

clinician involvement. 

Some forms of health IT are inextricably linked to medical devices, such as the software that 

interprets fetal heart monitors or automatically doses certain medications. In these cases, 

regulation of the medical software as a device is probably appropriate. However, the majority 

of medical software, including clinical decision support and EHRs, does not directly treat the 

patient, but rather provides data and guidance to the clinician in the assessment or treatment 

of a patient. 

The ability of the physician to utilize professional judgment when interacting with these forms 

of health IT makes these types of technology fundamentally different from traditional medical 

devices. 

Mr. Chairman, we are using a 40 year old law to regulate rapidly changing and dynamic 

technology. We are regulating manufacturing instead of use, and we are marginalizing the role 

of clinicians. Simply put, we must not impede medical advances with medical device regulation 

that is ill-suited for health IT. 

The FDA Safety and Innovation Act that was enacted last summer requires the FDA, the Office of 

the National Coordinator (ONC) of Health IT and the Federal Communications Commission (FCC) 

to provide Congress with recommendations on a new risk-based regulatory framework for 

health IT. 
92 


80806.033

To assist these agencies in better understanding the stakeholder perspective, the Bipartisan 

Policy Center (BPC) convened nearly 100 organizations and companies throughout the 

healthcare system over the past five months to develop a set of principles to guide the 

establishment of a risk-based regulatory framework for health IT. The results of this 

extraordinary collaborative effort were announced last month. 

The BPC recommendations are best reflected in the chart on page 13 of the BPC report that has 

been submitted with my testimony. This chart represents a new regulatory framework for 

health IT -one that protects patient safety, is risk-based, promotes innovation, is flexible, 

leverages existing quality and patient safety-related systems and processes, avoids regulatory 

duplication, and has the support of experts and stakeholders across every sector of health care. 

Most importantly, the BPC recommendations divide health IT into three categories according to 

the relative risk to patients and the opportunity for clinical intervention. 

The first category includes technology linked to or used to operate a medical device; again, 

technology that directly touches the patient. This technology would continue to be regulated 

by the FDA as a "medical device". 

The second category includes technology that informs the treatment of a patient, such as 

clinical decision support software or EHRs. This software would be subject to a rigorous process 

of accreditation by an independent third-party, or perhaps ONe. 

Finally, the third category, non-clinical technology such as billing and scheduling software, 

would not be subject to any regulatory oversight. 
93 


80806.034

This proposed framework recognizes the fundamental difference between traditional medical 

devices that are directly involved in the treatment of a patient, and medical software that helps 

guide the physician in the diagnosis or treatment of a patient. 

Mr. Chairman, health IT is imperative to the successful transformation of healthcare. It 

improves quality and patient safety, enables payment and delivery reform and promotes 

efficiency and lower costs. It is an essential building block of everything we are trying to 

accomplish in healthcare. That is why it is so important that we regulate it thoughtfully. That is 

why we cannot have a one size fits all approach which stifles innovation and delays advances in 

medical knowledge and care. That is why we need a new risk-based regulatoryframework. 

McKesson appreciates the opportunity to share our views on health IT with the members of the 

Subcommittee, and we look forward to continuing to promote the development and use of this 

important technology that is so vital to patient care. 

I am happy to answer your questions. 
94 


80806.095

Bipartisan Policy Center Health Innovation 

Initiative 

February 2013 
95 


80806.096

ABOUT BPC 

Founded in 2007 by former Senate Majority Leaders Howard Baker, 

Tom Daschle, Bob Dole, and George Mitchell, Bipartisan Policy 

Center (BPC) is a non-profit organization that drives principled 

solutions through rigorous analysis, reasoned negotiation, and 

respectful dialogue, With projects in multiple issue areas, BPC 

combines politically balanced policy making with strong, proactive 

advocacy and outreach, 

DISCLAIMER 

This report is the product of the Bipartisan Policy 

Center's Health Project, The findings and recommendations 

expressed herein do not necessarily represent the views or opinions 

of the Bipartisan Policy Center, its founders, or its board of directors. 

A':"I O\lersight FramC\'viJrk fo'" Assu(ng Patient Safety in Health Infor:-nation Technology) 2 
96 


80806.097

Executive Summary ................................................................................................. 4 

Introduction .............................................................................................................. 7 

Chapter 1: Principles for a Framework for 

Assuring Safety in Health IT ..................................................................................... 9 

Chapter 2: Key Elements of an Oversight 

Framework for Assuring Safety in Health IT ......................................................... 13 

Chapter 3: Recommendations for an 

Oversight Framework for Safety in Health IT ....................................................... 18 

Conclusion ............................................................................................................. 30 

About the Bipartisan Policy Center's Health 

Innovation Initiative ............................................................................................... 31 

Acknowledgements .............................................................................................. 32 

Endnotes ................................................................................................................. 34 

1\;-) Ove,sight F-z,:-ncwork f0; Assur:ng Patient Safety in Health Infor:-nation Techno:ogy i 3 
97 


80806.098

More than ten years ago, the Institute of Medicine (10M) released two landmark reports that 

catalyzed efforts to improve patient safety in U.S. health care.'" Both reports highlighted 

the critical role that health information technology (IT) plays in improving the quality and 

safety of care. Because greater use of health IT has always had strong bipartisan support, 

members of Congress and leaders across two administrations have taken significant actions 

to increase the adoption of IT to improve the quality, safety, and cost-effectiveness of 

health care. 

Building upon numerous legislative proposals with bipartisan support over the last decade, 

the Health Information Technology and Economic and Clinical Health CHITECH) Act of 2009 

brought about new authorities, standards, and investments in health IT. As a result of 

federal, state, and private-sector action, the number of clinicians, hospitals, and other 

providers across the United States who have adopted health IT to improve the quality, 

safety, and efficiency of care has significantly increased. 

The widespread adoption of health IT largely stems from recognition of the important role 

that it plays in improving health care quality and safety. However, there are also instances 

in which it has the potential to create harm if not effectively developed, implemented, or 

used. Nonetheless, a recent IOM report indicated that health information systems were 

involved in less than 1 percent of reported errors in health care settings. 3 

Policies are now being developed by the Department of Health and Human Services (HHS) 

to use health IT to make health care safer and continuously improve the safety of health IT. 

HHS released for public comment on December 21, 2012, the Health IT Patient Safety 

Action and Surveillance Plan for Public Comment, which represents the administration's 

proposed approach for addressing safety in health IT. The Food and Drug Administration 

(FDA) Safety and Innovation Act of 2012, which was passed by Congress and signed into 

law in July 2012, calls for the HHS secretary to develop-within 18 months-a proposed 

strategy and recommendations on risk-based regulatory framework pertaining to health IT 

that promotes innovation, protects patient safety, and avoids regulatory duplication. 4 

Through a collaborative effort, the Bipartisan Policy Center CBPC) has both conducted 

research and engaged a wide range of experts and stakeholders to develop a set of 

principles and recommendations for an oversight framework for assuring patient safety in 

health IT. The framework protects patient safety, is risk-based, promotes innovation, is 

flexible, leverages existing quality and patient safety-related systems and processes, avoids 

regulatory duplication, and has the support of experts and stakeholders across every sector 

of health care. 

An Oversight Fra'ilev,lo~k fo:- AS5ur'ng Patient Safety in Health Information Techno:ogy 1 4 
98 


80806.099

Principles for an Oversight Framework for Assuring 

Patient Safety in Health IT 

The following set of principles, which were developed through a collaborative process 

involving experts and stakeholders across every sector of health care, should guide the 

federal government's strategy and recommendations for a regulatory framework for health 

IT. 

1. Any oversight framework for safety should recognize and support the important role 

that health IT plays in improving the quality, safety, and cost-effectiveness of care, 

as well as the patient's experience of care. 

2. Assuring patient safety, along with enabling positive patient outcomes, is a shared 

responsibility that must involve the entire health care system. 

3. Any framework for patient safety in health IT should be risk-based, flexible, and not 

stifle innovation. 

4. Existing safety and quality-related processes, systems, and standards should be 

leveraged for patient safety in health IT. 

5. Reporting of patient safety events related to health IT is essential; a non-punitive 

environment should be established to encourage reporting, learning, and 

improvement. 

Key Elements of an Oversight Framework for Assuring 

Patient Safety in Health IT 

Assuring patient safety in the development, implementation, and use of health IT requires 

both national focus and public- and private-sector collaboration and leadership. 

Health IT broadly falls into three major categories, each of which reflects increasing levels of 

risk of potential patient harm: (1) administrative or non-clinical software, (2) clinical 

software, and (3) medical device software. The primary factors that should be used to 

determine the level of oversight for any type of software include the level of risk of potential 

patient harm and, for clinical software, the degree of direct clinical action on patients. 

Assuring safety in clinical software in particular is a shared responsibility among developers, 

implementers, and users across the various stages of the health IT life cycle, which include 

design and development; implementation and customization; upgrades, maintenance, and 

operations; and risk identification, mitigation and remediation. 

Clinical software includes electronic health records, clinical decision support software, and 

other software used to inform clinical decision-making. Such software should be subject to a 

new oversight framework, rather than traditional regulatory approaches applied to medical 

A,;,; Oversight Fra:1le\"vo;k fo" Assuring Patient Safety in Health Inforllatio'1 Technology i 5 
99 


80806.100

devices given its lower risk profile taking into account several factors. These factors include 

the level of risk of potential patient harm, the degree of direct clinical action on patients, the 

opportunity for clinician involvement, the nature and pace of its development, and the 

number of factors beyond the development stage that impact its level of safety in 

implementation and use. This oversight framework should contain four main elements 

summarized below. 

1. Agreement on and adherence to recognized standards and guidelines for assuring 

patient safety in the development, implementation, and use of health IT. 

2. Support for the implementation of standards and guidelines as well as development 

and dissemination of best practices through education, training, and technical 

assistance. 

3. Developer, implementer, and user participation in patient safety activities, including 

reporting, analysis, and response, while leveraging patient safety organizations 

(PSOs). 

4. Creation of a learning environment through the aggregation and analysis of data to 

identify and monitor trends, mitigate future risk, and facilitate learning and 

improvement. 

HHS's current proposed approach-outlined in Health IT Patient Safety Action and 

Surveillance Plan for Public Comment, which was released on December 21, 2012-reflects 

many of the key elements outlined above, including development of and adherence to 

standards and guidelines; reporting and analysis of, and response to patient safety events 

in a non-punitive environment to support mitigation of risk, as well as learning and 

improvement; and research and implementation support for users, developers, and 

implementers. 

As HHS develops its proposed strategy and recommendations for a risk-based, regulatory 

framework for health IT, BPC urges the department to conSider the principles and 

recommendations for an oversight framework for health IT outlined above and within this 

report. 

A-:1 Oversight Fratnewo"'k for Assur:ng Patient Safety I!l Health Infor:"nation TechrlO!ogy i 6 
100 


80806.101

More than ten years ago, the Institute of Medicine (IOM) released two landmark reports that 

catalyzed efforts to improve patient safety in U.S. health care.'" Both reports highlighted 

the critical role that health information technology (IT) plays in improving the quality and 

safety of care. Because greater use of health IT has always had strong bipartisan support, 

members of Congress and leaders across two administrations have taken significant actions 

to increase the adoption of IT to improve the quality, safety, and cost-effectiveness of 

health care. 

Today, health care costs constitute 18 percent of our nation's gross domestic product and 

the quality of care remains uneven. Rapidly emerging delivery system and payment models 

designed to improve quality, reduce costs, and improve the patient's experience of care 

require a strong IT foundation to be successful. Several studies have shown that health IT, 

if effectively designed and implemented, has a positive impact on patient safety, the 

efficiency and effectiveness of care, and patient and provider satisfaction.7 

Building upon numerous legislative proposals with bipartisan support, the Health 

Information Technology and Economic and Clinical Health (HITECH) Act of 2009 brought 

about new authorities, standards, and investments in health IT. Numerous states and 

private-sector health plans have also implemented policies that promote the adoption and 

use of health IT. As a result of these efforts, the percentage of office-based physicians who 

have adopted a basic electronic health record (EHR) has more than tripled in the last five 

years, totaling 40 percent in 2012.' In 2011, 18 percent of hospitals had a basic EHR 

system in place, up from 11.5 percent the previous year.' Many clinicians, hospitals, and 

other providers have qualified for funding under the Centers for Medicare and Medicaid 

Services (CMS) EHR Incentive Programs by demonstrating the meaningful use of EHR 

technology to improve care. As of December 31, 2012, more than $10.7 billion in payments 

had been made through these incentive programs to approximately 3,500 hospitals and 

more than 186,000 eligible professionals." 

The widespread adoption of health IT largely stems from recognition of the important role 

that it plays in improving health care quality and safety. However, there are also instances 

in which it has the potential to create harm if not effectively developed, implemented, or 

used. A recent rOM report indicated that health information systems were involved in less 

than 1 percent of reported errors in health care settings.ll A recently published advisory 

notice from the Pennsylvania Patient Safety Authority noted that only 3,900 of 1.7 million 

reports were found to involve health IT." 

Policies are now being developed by the Department of Health and Human Services (HHS) 

to use health IT to make health care safer and to continuously improve the safety of health 

A! Ove:-sight F'"'qmework for Assur:ng Patient Safety in Health Inforrnatio,1 Techilo:ogy I 7 
101 


80806.102

IT. The Office of the National Coordinator for Health IT (ONC) commissioned an 10M study 

on how government and the private sector can maximize the safety of health IT-assisted 

care. The report, Health IT and Patient Safety: Building Safer Systems for Better Care, was 

released in November 2011. On December 21, 2012, HHS released Health IT Patient Safety 

Action and Surveillance Plan for Public Comment, which represents the administration's 

proposed approach for addressing safety in health IT. 

The Food and Drug Administration (FDA) Safety and Innovation Act of 2012, which was 

passed by Congress and signed into law in July 2012, requires the HHS secretary, "acting 

through the Commissioner of Food and Drugs, and in consultation with the National 

Coordinator for Health Information Technology and the Chairman of the Federal 

Communications Commission," to post a report within 18 months that "contains a proposed 

strategy and recommendations on an appropriate, risk-based regulatory framework 

pertaining to health information technology, including mobile medical applications, that 

promotes innovation, protects patient safety, and avoids regulatory duplication."" 

Through a collaborative effort, the Bipartisan Policy Center CBPC) has both conducted 

research and engaged a wide range of experts and stakeholders-including clinicians, 

consumers, employers, health plans, hospitals, quality and patient safety organizations, 

academic and research institutions, and technology companies-to inform federal policy 

related to patient safety and health IT. As a result of the review of the literature and more 

than 40 meetings involving nearly 100 organizations representing diverse interests in health 

care, BPC has developed a set of principles and recommendations for an oversight 

framework for assuring patient safety in health IT. The framework protects patient safety, is 

risk-based, promotes innovation, is flexible, leverages existing quality and patient safetyrelated systems and processes, avoids regulatory duplication, and has the support of 

experts and stakeholders across every sector of health care. 

p.,'j Ovcrslgb,t F"'a;nework for Assu(ng Patent Safety in Health Jnfor'11atlo~ Techno;ogy I 8 
102 


80806.103

The following set of principles, developed through a collaborative process involving experts 

and stakeholders across every sector of health care, should guide the federal government's 

development of an oversight framework for assuring patient safety in health IT. 

1. Any framework for safety should recognize and 

support the important role that health IT plays in 

improving the quality, safety, and costeffectiveness of care, as well as the patient's 

experience of care. 

Research shows that health IT has a positive impact on the quality, safety, and costeffectiveness of health care." Health IT plays a foundational role in the broadly 

supported national imperative to improve health and health care for all Americans. 

While the widespread adoption of health IT largely stems from recognition of the 

important role that it plays in improving health care quality and safety, there are also 

instances in which it can create harm if not effectively developed, implemented, or used. 

Because of the significant role that health IT plays in improving the quality, safety, and 

cost-effectiveness of care, as well as the patient's experience of care, any framework for 

safety should both recognize and support innovation in and adoption of health IT. 

2. Assuring patient safety, along with enabling 

positive patient outcomes, is a shared responsibility 

that must involve the entire health care system. 

A'I Oversight F~a:-nework for Assuring Parent Safety in Hea!th Inforllation Tcch,10iogy i 9 
103 


80806.104

Assuring patient safety in health IT is a shared responsibility among the many 

stakeholders within the health care ecosystem. As noted in the recent roM report, safety 

is part of a larger sociotechnical system that takes into account not just the software, 

but also how it is used." This larger system includes technology, people, processes, 

organizations, and the external environment." 

The level of safety in health IT depends on how the technology is designed, customized, 

implemented, used, maintained, and incorporated into clinical workflows. The quality of 

data, the interoperability of IT systems, and the appropriateness of clinical interventions 

also have an impact on health IT safety. Additionally, education, training, and 

proficiency of users can playa critical role. Finally, health IT supports-but does not 

replace-the judgment of clinicians. 

Any oversight framework for safety in health IT should have strong support from and 

involvement of all stakeholders, including patients. 

3. Any framework for patient safety in health IT should 

be risk-based, flexible, and should not stifle 

innovation. 

The scale and scope of oversight requirements intended to ensure patient safety in 

health IT should be correlated to the potential risk of harm to patients. 

Health care is a continually evolving ecosystem that is now undergoing considerable 

change. Health IT plays a foundational role for rapidly emerging new models of delivery 

and payment that promise to improve the quality, safety, and cost-effectiveness of care, 

such as accountable care arrangements and the patient-centered medical home. 

Health IT must evolve to support rapidly emerging changes in the health care system 

and must continually be upgraded and/or customized to address the ever-changing 

needs of those who deliver, manage, pay for, and receive care. Innovation is needed to 

continually drive improvements in the cost, quality, and patient experience of care. 

Any framework for safety in health IT must be flexible and promote-not stifle-the 

innovation needed to drive further improvements in health and health care. Current 

regulatory frameworks that are oriented toward turnkey devices that change 

infrequently and are often not customized based on the needs of the user, do not align 

well with the current and anticipated nature of health IT. 

An Oveisight Framevlork for Assu:-ing Patient Safety !'l Hea:t'1 Info"Tnation Techno!ogy ! 10 
104 


80806.105

4. Existing safety and quality-related processes, 

systems, and standards should be leveraged for 

patient safety in health IT. 

Policies, processes, and systems associated with assuring safety in health IT should be 

aligned with and integrated into well-established patient safety and quality programs, 

including those that involve accreditation, certification, and reporting. 

Quality management and safety principles, processes, and standards, which are wellestablished and common to other industries, should also be leveraged for assuring 

patient safety in health IT. 

Health IT is an essential component of a comprehensive approach to improving patient 

outcomes and assuring the quality, safety, and efficiency of health care. Any oversight 

framework for health IT should align with and leverage existing processes, systems, and 

standards in health care, and should discourage or prevent duplicative or inconsistent 

requirements. 

5. Reporting of patient safety events related to health 

IT is essential; a non-punitive environment should be 

established to encourage reporting, learning, and 

improvement. 

Any framework for patient safety in health IT should be data-driven. It should support 

and promote reporting, sharing, and analysis of patient safety events in a non-punitive 

environment that maintains confidentiality and enables learning and improvement. 

Reporting of patient safety events by users, developers, implementers, and patients is 

essential to both gaining an understanding of the nature and magnitude of health ITrelated safety events and developing and implementing strategies to address risks. 

Aggregation and analysis of events and timely feedback to developers, implementers, 

and users are also crucial, so that necessary changes can be made to address identified 

issues and to mitigate future risk. 

Existing reporting processes and bodies, such as those created by the Patient Safety and 

Quality Improvement Act, should be leveraged. Reporting efforts should be coordinated. 

They should take into account existing work flows, and the burden of reporting should 

be minimized. The use of consistent formats for reporting should be encouraged so that 

data can be easily aggregated and analyzed to support learning and improvement. 

An Oversig'lt Framework for Assuring Patient Safety :n Healh Info'-mation Technology! 11 
105 


80806.106

Reporting policies should encourage reporting for learning and improvement. As noted in 

the recent IOM report, "in other countries and industries, reporting systems differ with 

respect to their design, but the majority employs reporting that is voluntary, confidential 

and non-punitive."" Lessons learned from such other approaches should be integrated 

into any oversight framework for health IT. 

An Oversight Framework for AS5Uri1l.g Patient Safety ":I Health Information Techno!ogy I 12 
106 


80806.107

Assuring patient safety in health IT is best accomplished through an oversight framework 

that reflects the principles outlined in this report. The framework should be risk-based and 

reflect shared responsibility, promote innovation, be flexible to accommodate a rapidly 

changing health care system, support learning and improvement, and leverage existing 

safety and quality-related processes, systems, and standards. 

Health IT broadly falls into three primary categories (illustrated in Figure 1 below), each of 

which reflects increasing levels of risk of potential patient harm: (1) administrative or nonclinical software, (2) clinical software, and (3) medical device software. 

Figure 
107 


80806.108

Administrative software-which supports the administrative and operational aspects of 

health care but is not used in the direct delivery of care-represents the category with the 

lowest level of risk of potential patient harm. One example of administrative software is 

scheduling software, which enables health care providers to schedule appointments with 

patients. Based on the level of risk of patient harm associated with such software, additional 

oversight is not warranted. 

Clinical software informs clinical decision-making and directly supports the delivery of care 

to patients. Examples include EHRs, computerized physician order entry, and clinical 

decision support software. 

Finally, medical devices, including medical device software, represent a high potential risk of 

patient harm and in most cases, directly interact with the patient with little or no 

opportunity for clinical intervention. Examples of traditional medical devices include 

pacemakers, electrocardiograms, automated external defibrillators, and mammography 

computer-aided detection systems. Such devices are currently regulated by the FDA as 

Class I, Class II, or Class III medical devices. 

As illustrated in Figure 2, factors used to determine the type of oversight to be applied 

include: the level of risk of potential patient harm and the degree of direct clinical action on 

patients. 

Figure 

l: 
108 


80806.109

The FDA's current regulatory approach for medical devices is generally not well-suited for 

health IT. Unlike medical devices, health IT relies not only on how it is designed and 

developed, but also on how it is customized, implemented, and used. Safety of medical 

devices is almost entirely dependent on how they are manufactured by developers-which is 

the focus of medical device regulation. Safety in health IT, however, is a shared 

responsibility among developers, implementers, and users across the various stages of the 

health IT life cycle, which include design and development; implementation and 

customization; upgrades, maintenance, and operations; and risk identification, mitigation, 

and remediation. 

"Developers" are defined as those who develop software for use in health care and can 

include commercial IT companies, academic institutions, and health care organizations. 

"Implementers" are defined as those who implement software in the health care setting, 

and can include the IT and medical informatics departments of provider institutions, 

consultants, commercial health IT companies, and, in some cases, clinicians and practice 

management staff. "Users" are defined as those who actually use the software. 

Other factors that impact the level of patient safety in the use of health IT include the 

quality of data that reSides in health IT systems, the level of interoperability and exchange 

of information across systems, the integration of the software into clinical work flows, and 

the appropriateness of clinical interventions. Unlike medical devices, health IT is designed to 

inform-not take the place of-clinical decision-making. Clinical software does not directly 

interact with patients as medical devices often do. Health IT supports but does not replace 
109 


80806.110

the judgment of clinicians. When using health IT for clinical care, clinicians ultimately retain 

clinical judgment and discretion. 

Another differentiation between medical devices and health IT is that health IT is constantly 

being upgraded and modified to reflect new evidence and clinical interventions, changing 

work flows, and new requirements now rapidly emerging from public- and private-sector 

agencies. Federal and state agencies as well as private-sector payers are increasingly calling 

upon clinicians, hospitals, and other providers to bolster health IT capabilities to support the 

implementation of new delivery system and payment reforms, as well as requirements for 

health IT incentive programs-such as those associated with CMS' Medicare and Medicaid 

EHR Incentive Programs. Constantly evolving systems, such as health IT, don't lend 

themselves to discontinuous oversight mechanisms such as those used for medical devices. 

Key Elements of the Oversight Framework for Clinical 

Software 

Assuring patient safety in the use of health IT-and in particular, clinical software-requires 

both national focus and public- and private-sector collaboration and leadership. As noted 

previously, this is best accomplished through an oversight framework that is not only riskbased and reflects shared responsibility, but also one that promotes innovation, is flexible to 

accommodate a rapidly changing health care system, supports learning and improvement, 

and leverages existing safety and quality-related processes, systems, and standards. 

As illustrated in Figure 4 below, the oversight framework for the safe use of clinical software 

should be composed of four main elements: 

1. Agreement on and adherence to recognized standards and guidelines for assuring 

patient safety in the development, implementation, and use of health IT. 

2. Support for the implementation of standards and guidelines as well as development 

and dissemination of best practices through education, training, and technical 

assistance. 

3. Developer, implementer, and user participation in patient safety activities, leveraging 

PSOs, including reporting, analysis, and response. 

4. Creation of a learning environment through the aggregation and analysis of data to 

identify and monitor trends, mitigate future risk, and facilitate learning and 

improvement. 

Addressing these four elements is a shared responsibility among developers, implementers, 

and users of clinical software. 

ffJ"n OverslQ"1t Framework for Assuring Patie'lt Safety 'n Hea!th I'Ifo"matlon Techno!ogy I 16 
110 


80806.111

The oversight framework for assuring patient safety in health IT outlined in this report 

aligns with the approach proposed in HHS' Health IT Patient Safety Action and Surveillance 

Plan for Public Comment in several ways, including: the focus on leveraging existing 

programs and processes, development of and adherence to standards, reporting and 

response by providers and health IT developers, aggregation and analysis of patient safety 

events to facilitate improvement, and provision of implementation support through research 

and development of user tools and best practices related to safety and health IT. As 

described in more detail below, the oversight framework relies on a process-oriented 

approach. The HHS plan calls for the use of process standards, but does so within the 

context of a product-focused EHR certification program. 

A more detailed description of each element of the oversight framework for clinical software 

is provided below, along with recommendations that will speed its implementation. 
111 


80806.112

1. Agreement on and Communication of a Health IT 

Safety Oversight Framework That Reflects Shared 

Principles and Builds upon Key Elements Addressed in 

This Report 

HHS has taken important steps to advance patient safety in health IT -enabled care. First, it 

commissioned an roM study on how government and the private sector can maximize the 

safety of health IT -assisted care. Second, on December 21, 2012, it published Health IT 

Patient Safety Action and Surveillance Plan for Public Comment, which represents the 

administration's proposed approach to patient safety in health IT. The administration's 

proposed action plan aligns with many of the principles outlined in this report and signals its 

intention to manage the oversight of health IT outside of the traditional medical device 

regulatory regime. 

The FDA Safety and Innovation Act of 2012, which was passed by Congress and signed into 

law in July 2012, calls for the HHS secretary to post-within 18 months-"a report that 

contains a proposed strategy and recommendations on an appropriate, risk-based 

regulatory framework pertaining to health information technology, including mobile medical 

applications, that promotes innovation, protects patient safety, and avoids regulatory 

duplication."" 

The possibility of government regulation in health IT has the potential of stifling innovation 

and much-needed investment in an industry that must significantly expand, evolve, and 

innovate to support the growing demands of a health care system that is undergoing 

considerable modernization and transformation to address continuing concerns about rising 

health care costs and uneven quality. 

An Overs:g~t Fral,lev\/ork for Assu~jng Patic:1t Safety in Hea!th hfo!-mation Techno!ogy I 18 
112 


80806.113

Imposing a new set of regulations in the midst of a health care environment that is already 

fiscally challenged and facing many new regulations and requirements brought about by the 

Affordable Care Act and HITECH, has the potential to overwhelm the system. 

At the same time, clinicians, hospitals and other providers, technology companies, and 

patients are seeking agreement and collaborative action on a set of principles, guidelines, 

processes, and systems that will support them in both using health IT to improve patient 

safety and improving the safety of health IT-assisted care. 

BPC has both conducted research and engaged a wide range of experts and stakeholders to 

inform this set of recommendations for an oversight framework for assuring patient safety 

in health IT. 

Recommendation 1.1 

As HHS finalizes its patient safety action and surveillance plan and develops its proposed 

strategy and recommendations for a risk-based, regulatory framework for health IT, we 

urge the department to consider the principles and recommendations for an oversight 

framework included in this report. 

The oversight framework for patient safety should reflect the following key principles: 

1. Recognize and support the important role that health IT plays in improving the 

quality, safety, and cost-effectiveness of care, as well as the patient's experience of 

care. 

2. Recognize that assuring patient safety, along with positive patient outcomes, is a 

shared responsibility that must involve the entire health care system. 

3. Be risk-based, flexible, and do not stifle innovation. 

4. Leverage existing safety and quality-related processes, systems, and standards. 

5. Recognize that reporting of patient safety events is essential and that a non-punitive 

environment should be established to encourage reporting, learning, and 

improvement. 

The oversight framework should enable national focus and public- and private-sector 

collaboration and leadership. Rather than rely upon existing approaches for the regulation of 

medical devices, the oversight framework for clinical software should call upon developers, 

implementers, users, PSOs, and experts, working in collaboration with government, to: 

1. Agree upon and promote adherence to-through accreditation, as appropriate--

recognized standards and guidelines for assuring patient safety in the development, 

implementation, and use of health IT. 

An Overs'gtlt Framei,,-'ork for .Assu:-i:rg Patient Safety in Heaith Infoi"matlon Tec'1!lo!ogy I 19 
113 


80806.114

2. Provide support for the implementation of such standards and guidelines as well as 

develop and disseminate best practices, through education, training, and technical 

assistance. 

3. Enable developer, implementer, and user participation in patient safety activities, 

leveraging PSOs, including reporting, analysis, and response. 

4. Create a learning environment; aggregate and analyze non-identified patient safety 

reports to identify and monitor trends, mitigate future risk, and facilitate learning 

and improvement. 

A description of each component of the oversight framework for clinical software and 

recommendations for the actions needed to support implementation are summarized below. 

2. Agreement on and Adherence to Recognized 

Standards and Guidelines for Assuring Patient Safety 

One of the key components of the oversight framework is a process for gaining agreement 

on process standards and guidelines for assuring patient safety in the development, 

implementation, and ongoing use of health IT. Developers, implementers, users, and 

patients, along with patient safety and health IT experts and government, should both 

inform and playa significant role in the development and continued evolution of such 

standards and guidelines. 

Because assurance of safety in health IT is a shared responsibility that is dependent on how 

it is developed, implemented, and used, standards and guidelines for assuring patient safety 

should focus on harmonized processes across the health IT life cycle-as opposed to 

technical requirements that are limited to specific functionality, such as those that playa 

predominant role within current EHR certification programs associated with CMS' Medicare 

and Medicaid EHR Incentive Programs. A process and life cycle approach inherently leads to 

higher product safety as it enables the delivery of defined and consistent outcomes. As 

noted in the IOM report on patient safety and health IT, experiences from other industries 

suggest the best approach to proactively creating highly reliable products is not to certify 

each individual product but rather, to make sure organizations have adopted qualitymanagement principles and processes in the design and development of products." 

Well-established international standards that enable patient safety already exist and are 

developed under the auspices of the International Organization for Standardization (ISO). 

Examples of such existing process standards include those that address qualitymanagement systems (ISO 9001), product risk management (ISO 14971), software 

development (ISO 62304), and usability (ISO 62366). The development of a new ISO 

standard focused on assuring the safer development, implementation, and operation of 

health software is currently underway." The complete range of existing standards and 

An OVNslg'lt Fr-;;Cii€V,'ork for Assuring Patient Safety :n Health Information Tec:ino!ogy I 20 
114 


80806.115

guidelines should be reviewed for applicability to health IT patient safety goals, gaps should 

be identified and modified, and new standards should be developed as needed. Funding of 

research in areas where gaps are identified will be needed. 

Finally, such standards and guidelines must continually evolve to address changing 

requirements and the identification of new issues that need focus. Standard and guideline 

development processes should be tightly linked to and informed by the analysis of 

aggregated reports from across the health care system, to facilitate learning and 

improvement. 

Independent "voluntary consensus bodies"-defined by OMB Circular A-119 as those that 

exhibit the attributes of openness, balance of interest, due process, an appeals process, and 

consensus-are in the best position to facilitate agreement among health care stakeholders 

on a recognized set of standards and guidelines for patient safety in health IT." Under the 

National Technology Transfer and Advancement Act of 1995 and OMB Circular A-119, the 

federal government is required to use standards developed by voluntary consensus bodies 

in its regulatory and procurement activities, unless the use of such standards would be 

inconsistent with applicable law or otherwise impractical.,,·23 

Recommendation 2.1 

Independent, voluntary consensus bodies should engage developers, implementers, users, 

health IT and safety experts, and consumers to gain ongoing agreement on a set of 

standards and guidelines for assuring patient safety in the design, development, 

implementation, and use of health IT. 

Recommendation 2.2 

Independent voluntary consensus bodies and organizations that represent developers, 

implementers, users, and patient safety and health IT experts should collaborate on the 

dissemination of agreed-upon standards and guidelines as well as on the development and 

delivery of educational programs and implementation support services designed to educate 

and promote compliance with such standards and guidelines. 

Recommendation 2.3 

Developers and software implementers that are not a part of provider organizations should 

demonstrate adherence to recognized and agreed-upon standards and guidelines by 

undergoing accreditation administered through independent, recognized bodies. 

Recommendation 2.4 

Existing, independent provider accreditation bodies should be evaluated for their reference 

and support of recognized standards and guidelines for software implementation and use. 

An Overs;g~t Framework for Assu~i:1g Patient Safety Heath Information Tec>-tnology I 21 
115 


80806.116

3. Support for Implementation of Standards and 

Guidelines; Development and Dissemination of Best 

Practices for Developers, Implementers, and Users 

Widespread dissemination of and support for the implementation of standards, guidelines, 

and best practices for assuring safety in the development, implementation, and use of 

clinical software is crucial. This can take the form of education, training, and implementation 

support services offered by organizations with expertise in this area, as well as those who 

work with software vendors, clinicians, hospitals, and other providers. 

Developers, implementers, and users will increasingly need to work together to develop 

strategies that meet the growing demands of a rapidly changing health care system. More 

dialogue and collaboration on best practices for assuring safety in the use of health IT is 

needed among those who develop, implement, and use software in health care. Fear of 

liability, punitive or regulatory action, and negative press, combined with some lack of trust, 

all serve as barriers to dialogue among clinicians, hospitals, and technology developers 

about the actions that can be taken to continually improve patient safety in health ITenabled care. 

Recommendation 3.1 

Developers, implementers, users, health IT and patient safety experts, and PSOs should 

collaborate on the development and dissemination of strategies and best practices for 

assuring patient safety in the design and development; implementation and customization; 

upgrade, maintenance, and operations; and risk identification, mitigation, and remediation 

phases of the health IT life cycle. Such strategies and best practices should align with 

recognized standards and guidelines. This will require significant investment of resources in 

research, collaboration, and dissemination. 

4. Participation in Patient Safety Activities Including 

Reporting, Analysis, and Response 

Reporting, analYSiS, and development and execution of corrective actions for individual 

patient safety events are critical components of an oversight framework for patient safety in 

health IT. 

An Overs:g"'lt F:-a01ework for Assuring Patient Safety it) Heaith Information Tec;'lno!ogy I 22 
116 


80806.117

LEVERAGING EXISTING PATIENT SAFETY-RELATED AUTHORITIES, 

ORGANIZATIONS, AND PROCESSES 

Congress passed the Patient Safety and Quality Improvement Act of 2005 (the Patient 

Safety Act), to encourage health care providers to voluntarily report information on patient 

safety events and to facilitate the development and adoption of interventions and solutions 

to improve patient safety. 

The Patient Safety Act authorized the creation of patient safety organizations (PSOs). PSOs, 

which must be certified for listing and evaluated on an ongoing basis by the Agency for 

Healthcare Research and Quality (AHRQ), serve as patient safety experts and receive data 

regarding patient safety events that are considered privileged and confidential. 24 

Currently, 88 PSOs are listed on the AHRQ website, representing a range of for-profit and 

not-for-profit organizations and entities that are components of other organizations, such as 

hospital associations, medical societies, or health systems." 

Rather than establish new authorities or structures for reporting and analysis of patient 

safety events specific to health IT, PSOs-who are already authorized to serve as patient 

safety experts and receive data regarding patient safety events that are considered 

privileged and confidential-should be leveraged to support reporting for patient safety 

events associated with health IT. 

Creating a safety reporting silo that only focuses on health IT would be duplicative, increase 

unnecessary burden, and also result in the failure to capture many relevant events. Patient 

safety events associated with health IT are often not identified as such until analysis has 

been performed by the PSO. Many patient safety problems that have health IT dimensions 

are characterized by the providers that report them in other ways, such as medication 

errors, patient identification errors, erroneous laboratory or radiology results, or 

documentation or communication errors. For example, 43 percent of the device and health 

IT events in one large PSO database were submitted in a non-health-IT-related category." 

Recommendation 4.1 

Authorities, structures, and organizations brought about by the Patient Safety and Quality 

Improvement Act-including patient safety organizations-should be leveraged to support 

reporting and analYSis of health IT-related patient safety events. 

ENABLING DEVELOPERS TO PARTICIPATE IN PATIENT SAFETY ACTIVITIES 

The Patient Safety Act establishes a culture of safety for providers by providing statutory 

confidentiality protections for "patient safety work product" (PSWP). Specifically, identifiable 

patient safety work product is defined, in part, as PSWP that is presented in a form and 

manner that allows the identification of any provider that is a subject of the work product, 

or any providers that partiCipate in activities that are a subject of the work product (42 USC 

299b-21(2)) . 

An Ovcrs:git FramevI:ork for Assuring Patient Safety :iI Health Information Tecflnology I 23 
117 


80806.118

This provision grew out of the 1999 roM Report To Err is Human, which reported that 

without protections providers did not share information about errors and thus the errors 

were repeated. The culture of safety permits providers to participate in activities intended to 

improve the quality of patient care without fear of liability or harm to professional 

reputation. Importantly, this provision does not exempt the provider from lawsuits; 

information in the medical record concerning the underlying facts is not protected under the 

Patient Safety Act and remains available to plaintiffs, just as it was before the passage of 

the Act. 

PSOs work with clinicians, hospitals, and other providers to analyze and understand the root 

cause of patient safety events, provide feedback, and develop and disseminate 

recommendations designed to improve quality and safety. In the case of patient safety 

events that involve health IT, developers and implementers of software also playa critical 

role in gaining an understanding of root cause and other contributing factors. 

Unless developers have a direct relationship with a PSO, they are not able to participate 

with the PSO in analyzing, identifying the root causes of, and developing corrective actions 

for health IT-related patient safety events, because sharing a report with them would break 

statutory confidentiality protections. Under the Patient Safety Act, developers may have a 

relationship with a PSO either by becoming a PSO, entering into a joint venture with the 

PSO, or serving under contract to the PSO, which permits them to participate in patient 

safety activities 

Because health IT safety is a shared responsibility, health IT developers must have the 

ability to participate with PSOs, clinicians, hospitals, and other providers in patient safety 

activities to improve the safety and quality of health IT-enabled care without breaking 

statutory confidentiality protections for providers. 

While clinicians, hospitals, and other providers are often in the best position to identify and 

report patient safety events associated with health IT, there may be situations in which 

developers or implementers of software are made aware of events associated with use of 

health IT products through communications with their clients. 

Because assuring safety is a shared responsibility, developers should participate in the 

reporting of patient safety events, just as providers do. Many providers voluntarily report 

patient safety events to PSOs. In addition, a majority of states have mandatory hospital and 

other health care provider reporting requirements related to events that cause death or 

serious harm." The Joint Commission, through its accreditation process, reviews hospitals' 

activities in response to sentinel events (which are unexpected occurrences involving death 

or serious injury) and encourages-but does not require-the reporting of such events to 

Joint Commission's Sentinel Event Database." Like providers, developers can be reluctant to 

report out of fear of legal liability or harm to reputation. 

The current law should be extended to provide confidentiality protections to health IT 

developers to permit them to report patient safety events, view PSO-protected information, 

receive and analyze event reports, create and receive quality-improvement 

.An O\/erS'9'lt Framev,lork for Assur!tjg Patient Safety ;1 Health Info-mat7on Technology I 24 
118 


80806.119

recommendations from the PSO, and work with the providers to develop strategies for 

improvement. 

Like providers, such protections would not exempt developers from lawsuits. Information in 

the patient's medical record concerning the underlying facts involving any health IT is not 

protected under the Patient Safety Act and remains available to plaintiffs. Therefore, 

extending the protections to develop a culture of safety would not limit a developer's 

potential liability if one of its products directly causes harm to a patient. Additionally, health 

IT developers and their products must also comply with existing federal or state consumer 

protection laws, as well as federal and state privacy and security laws and regulations. In 

summary, expanded protections for developers would not affect laws that are intended to 

protect patients and consumers. 

Recommendation 4.2 

Because assuring patient safety in health IT is a shared responsibility, developers-like 

providers--should report patient safety events to PSOs, as appropriate, with expanded 

protections and requirements for reporting of events that cause death or serious harm. 

Recommendation 4.3 

The Agency for Healthcare Research and Quality should explore options for enabling 

developers to participate in patient safety activities with protections. Such participation 

would include reporting, review and analysis of patient safety events that are health ITrelated, creation and receipt of quality improvement recommendations from the PSO 

associated with a specific event, and dialogue with the PSO and provider regarding 

corrective actions that can be taken to mitigate further risk. 

REMOVING BARRIERS TO REPORTING AMONG CLINICIANS AND OTHER 

PROVIDERS 

One of the primary barriers to reporting among clinicians, hospitals, and other providers is 

the burden of reporting and its impact on current work flows. The administration and 

management of reporting takes considerable time and resources. Reporting efforts should 

be designed to minimize the burden of reporting. To the extent feasible and pOSSible, 

reporting should be embedded into current work flows and health IT systems. Another key 

barrier is the lack of awareness or understanding of the confidentiality protections under the 

Patient Safety Act. Awareness-building and education programs designed to explain and 

clarify both the benefits of reporting and the confidentiality protections that are in place can 

support expanded reporting by clinicians, as well as other providers. 

Other barriers to patient safety reporting cited by clinicians include fear of breaching 

confidentiality provisions of contracts with their health IT vendors and, in some cases, 

perceived institutional barriers to reporting. Raising awareness among clinicians and other 

providers by health IT vendors regarding the permissibility of reporting patient safety 

,';11 Ovcrs:g1t Framev,;ork for AS5uri~lg Patient Safety 11 Hea!th Info'-mation Tec'Inology I 25 
119 


80806.120

events to their PSOs under existing contracts, and further clarifying such language in future 

contracts, can help to allay such fears among clinicians and other providers. Increasing 

awareness of the importance of and policies associated with patient safety reporting within 

institutions can also reduce clinician-perceived barriers to reporting. 

Patient safety event reporting, analysis, identification of root cause, and corrective action 

are critical to improving patient safety in health IT-assisted care. Those who develop, 

implement, and use health IT should be encouraged to report patient safety events to 

facilitate learning and improvement and mitigate future risk. 

Recommendation 4.4 

Organizations representing PSOs, developers, clinicians, hospitals, and other providers 

should take steps to encourage reporting of patient safety events-including those related to 

health IT. This can be accomplished by raising awareness of the benefits of reporting and 

clarifying the confidentiality protections in place to support such reporting. Expanded 

reporting will further the ability to learn more about the nature and prevalence of risk, 

enable the development of strategies and best practices to address areas of risk, and 

facilitate improvement in the quality and safety of health care. 

Recommendation 4.5 

To address the perceptions of some clinicians that patient safety reporting might breach the 

confidentiality provisions of contracts with their health IT vendors, developers should raise 

awareness among their clients that reporting of patient safety events to their PSOs is indeed 

permissible under their existing contracts. In cases where there is lack of clarity, developers 

should work to clarify such language in future contracts to help allay fears among those 

clinicians and other providers who perceive contractual language to be a barrier. 

EXPANDING PSO CAPABILITIES ASSOCIATED WITH HEALTH IT-RELATED PATIENT 

SAFETY EVENTS 

While there is a great deal of literature on improving patient safety generally in health care, 

relatively little is known or has been published about the nature and prevalence of patient 

safety events associated with health IT development and use. 

The development of standards, guidelines, and best practices for traditional PSO activitiessuch as reporting and analysis of reported events, development of corrective action plans, 

aggregation and analysis of large data sets, and development of strategies to mitigate 

future risk for health IT-related patient safety events-is needed. Such development must 

necessarily occur with significant involvement of developers, implementers, users, and 

patient safety and health IT experts. 

As clinicians, hospitals and other providers, and developers increasingly begin to rely on 

PSOs for the reporting of patient safety events that are or may be associated with health IT, 

they will expect that PSOs offering such services will have the expertise and capabilities 

Ai1 Oversight Framework for Assuring Patient Safety';) Health Info~mation Technology! 26 
120 


80806.121

associated with this new and emerging field. While baseline knowledge and capabilities 

should be expected of all PSOs, demonstration and communication of advanced capabilities 

will help developers, implementers, and users identify PSOs with which they wish to 

establish a relationship to support reporting of patient safety events associated with health 

IT. Demonstration of such advanced capability could be accomplished through a PSO-Ied 

accreditation program associated with health IT-related patient safety events, with support 

by developers, implementers, users, and experts in both patient safety and health IT. 

Recommendation 4.6 

PSOs, developers, implementers, users, and health IT and patient safety experts should 

collaborate on the development of standards, guidelines, strategies, and best practices for 

collecting, analyzing, and investigating health IT-related patient safety events; defining 

corrective action and providing timely feedback; and taking other actions as necessary to 

mitigate future risk and facilitate leaming and improvement. 

Recommendation 4.7 

PSOs should collaborate with developers, implementers, users, and patient safety and 

health IT experts on the development and launch of an accreditation program that reflects 

established standards, guidelines, and best practices and promotes effective implementation 

of patient safety activities related to health IT. PSOs that wish to specialize in health ITrelated patient safety activities should undergo such accreditation. 

5. Creation of a Learning Environment for Safety in 

Health IT 

Reporting and responding to individual events is a critical means to enhance safety, but it is 

not enough. Aggregating and analyzing reports across large populations enables a more 

rapid identification of underlying patterns and trends as well as emerging risks and the 

causes of those risks. Aggregation and analysis of patient safety data also supports the 

development and implementation of interventions to mitigate risk and enable system-wide 

learning and improvement. 

To support PSOs and providers in their efforts to develop and adopt improvements in 

patient safety, the Patient Safety Act authorized AHRQ to facilitate the development of a 

network of patient safety databases (NPSD), to which PSOs, health care providers, or others 

can voluntarily contribute non-identifiable patient safety work product. By facilitating the 

aggregation and analysis of data nationwide, the NPSD is intended to assist PSOs and 

providers in their efforts to develop and adopt improvements in patient safety. 29 

Another way in which aggregation, analysis, and improvement activities can take place with 

the support of confidentiality protections under the Patient Safety Act is through the 

aggregation and analysis of non-identified patient safety from numerous PSOs into another 

An O\'ersig~t Frame\iI,'ork for Assuring Patle:it Safety :1 Hea1tf1 Informat;on Technology j 27 
121 


80806.122

PSO that focuses on aggregation and analysis. As patient safety reporting for health IT 

takes hold, it is likely that a combination of the two scenarios identified above will emerge. 

Regardless of the mechanisms used, appropriate governance, policies, protections, and 

capabilities will need to be established for entities that choose to aggregate large sets of 

patient safety data to garner trust, assure confidentiality, provide ease of use, minimize 

burden, and deliver value to participants-ali of which will be required to promote significant 

participation and long-term sustainability. 

Recommendation 5.1 

Developers, implementers, users, PSOs, patient safety and health IT experts, and 

consumers should collaborate on the development of key attributes and requirements 

associated with the aggregation and analysis of non-identified patient safety event data to 

facilitate learning and to assure patient safety in the use of health IT. Such attributes and 

requirements will inform PSOs that wish to provide services associated with patient safety in 

health IT and help them gain the participation and support of developers, implementers, 

and users who wish to participate in aggregated reporting efforts designed to promote 

safety in health IT. 

ENCOURAGING USE OF STANDARD FORMATS FOR REPORTING AND RESPONSE 

The use of standardized formats for reporting will significantly improve the ability for data to 

be aggregated and analyzed to support system-wide response and improvement. 

As noted previously, the Patient Safety Act requires PSOs-to the extent practical and 

appropriate-to collect patient safety data from providers in a standardized manner. If 

providers or PSOs choose to submit patient safety data to the NPSD, AHRQ requires that 

these data be submitted using the AHRQ Common Formats, which are common definitions 

and reporting formats used to facilitate the collection and reporting of patient safety events. 

To date, AHRQ has developed Common Formats for two settings of care-acute care 

hospitals and skilled nursing facilities. Future versions of the Common Formats are being 

developed for ambulatory settings. AHRQ has also developed Common Formats to support 

the reporting of patient safety events related to health IT." 

Recognizing the importance of using standard formats for the reporting of patient safety 

events to enable aggregation, analysis, and identification of interventions that mitigate risk 

and support improvement; developers, implementers, and users who report patient safety 

events either to a PSO or the NPSD should be encouraged to utilize standardized formats. 

To the extent feasible and appropriate, the AHRQ Common Formats should be leveraged to 

support reporting using standardized formats. 

An Oversight Framework for Assuriilg Patre:!t Safety >1 Hea:th I'lfor-matlon Technology I 28 
122 


80806.123

Recommendation 5.2 

Developers, implementers, users, and PSOs that report patient safety events should utilize 

standardized formats for such reporting-including those related to health IT. 

Recommendation 5.3 

Given the increase in adoption of EHRs among clinicians in ambulatory settings and given 

the critical importance of patient safety reports from such environments-particularly as it 

relates to health IT, AHRQ should continue and accelerate its efforts to develop Common 

Formats for ambulatory care. 

Recommendation 5.4 

To facilitate the aggregation and analysis of patient safety data to support learning and 

improvement in the area of health IT, PSOs should explore aggregating patient safety 

events associated with health IT either through reporting to the NPSD or to another PSO 

that is aggregating such data to support learning and improvement. 

An Overslg1t Framework for Assu;ing Patieit Safety Heait!-) Information Technology I 29 
123 


80806.124

Health IT plays a critical role in improving the quality, safety, and cost-effectiveness of care. 

Continuing to use health IT to make health care safer and assuring the safety of health IT is 

essential. Through the implementation of the principles and recommendations summarized 

in this report, the federal government, states, and private-sector leaders across every 

sector of health care can make significant strides in achieving these dual goals, while 

continuing to improve how health care is delivered in the United States. 

As policy makers consider the development of a regulatory framework for health IT, we urge 

them to consider the oversight framework outlined in this report, which protects patient 

safety, is risk-based, promotes innovation, is flexible, leverages existing quality and patient 

safety-related systems and processes, avoids regulatory duplication, and has the support of 

experts and stakeholders across every sector of health care. 

BPC thanks the many organizations and individuals, listed in the acknowledgements section 

of this report, who contributed their time and expertise to the development of principles and 

recommendations included in this report. 

Through the BPC Health Innovation Initiative, we plan to continue the dialogue on the 

principles, policies, and strategies that should be adopted to promote the use of health IT to 

improve patient safety, while assuring safety in the development, implementation, and use 

of health IT. 

An Oversight Framev\,ork for Assuring Patie:lt Safety :'1 Hea!th Info:-mation Techno!ogy I 30 
124 


80806.125

Founded in 2007 by former Senate Majority Leaders Howard Baker, Tom Daschle, Bob Dole, 

and George Mitchell, BPC is a nonprofit organization that drives principled solutions through 

rigorous analYSiS, reasoned negotiation, and respectful dialogue. With projects in multiple 

issue areas, BPC combines politically balanced policy making with strong, proactive 

advocacy and outreach. See www.bjQ1trtis'mQoli<;;~Qm, 

In coordination with BPC's Health Project, which is led by Health Project co-leaders and 

former Senate Majority Leaders Tom Daschle (D-SD) and Bill Frist (R-TN), the Health 

Innovation Initiative conducts research and collaborates with experts and stakeholders 

across health care to develop recommendations that promote innovation as well as the use 

of IT to drive improvements in the cost, quality, and patient experience of care. Key areas 

of focus include the following: 

1. Creating the information foundation for delivery system and payment reforms that 

promote higher-quality, more cost-effective care. 

2. Expanding engagement of consumers in their health and health care to improve 

outcomes in cost, quality, and patient experience of care. 

3. Accelerating the electronic exchange of health information across the multiple 

settings in which care and services are delivered to support coordinated, 

accountable, patient-centered care that improves quality and reduces costs. 

4. Assuring privacy and security of electronic health information by gaining agreement 

among stakeholders in health care on a set of principles, poliCies, and strategies for 

managing privacy as it relates to both the delivery of care and improvements in 

population health. 

5. Assuring patient safety in health IT, while preserving an environment that fosters the 

innovation needed for a rapidly changing health care system. 

6. Advancing innovation in new areas that will promote better outcomes in quality and 

cost, including those related to personalized and genomic medicine. 

An Ovcrsig'it Frarnework for AssU'-ing Patie1t Safety ·1 Hea:th Info;"mation Technology! 31 
125 


80806.126

BPC would like to thank Janet Marchibroda, director of the BPC Health Innovation Initiative; 

Katie Golden, BPC health policy analyst; and Ann Gordon, writer and editor, for their 

contributions to this report. 

BPC would also like to thank the following organizations, which contributed their time and 

expertise to the development of the principles and recommendations included in this report. 

Aetna 

Alliance for Quality Improvement and 

Patient Safety 

Allscripts 

American Academy of Family Physicians 

American Academy of Pediatrics 

American Cancer Society 

American College of Cardiology 

American College of Emergency Physicians 

American College of Physician Executives 

American College of Physicians 

American College of Surgeons 

American Congress of Obstetricians and 

Gynecologists 

American Medical Group Association 

American Medical Informatics Association 

American Nurses Association 

American Osteopathic Association 

American Society of Clinical Oncology 

Ascension Health 

Association of American Medical Colleges 

Association of Clinicians for the 

Underserved 

Association of Medical Directors of 

Information Systems 

athena health 

AT&T 

Baylor Health System 

Blue Cross Blue Shield Association 

Brookings Institution 

CentraStateHealth System 

Cerner Corporation 

CHIME 

Continua Health Alliance 

Dell 

ECRI Institute 

e-MDs 

GE Healthcare 

Geisinger Health System 

Greenway Medical Technologies 

An Overs1glt Frame\NOrk for Assuri;)g Patient Safety !:l Hea:th InfOi"matlon Technology I 32 
126 


80806.127

HCA Healthcare 

Health Fidelity 

Healthcare Leadership Council 

Health Level Seven 

HIMSS 

IBM Corporation 

Intel Corporation 

Intermountain Healthcare 

Joint Commission 

Kaiser Permanente 

McKesson Corporation 

Medical Group Management Association 

Medtronic 

National Association of Children's 

Hospitals and Related Institutions 

National Association of Public Hospitals 

and Health Systems 

National Coalition for Cancer Survivorship 

National Medical Association 

National Partnership for Women and 

Families 

National Patient Safety Foundation 

National Rural Health Association 

New York Presbyterian Hospitals 

NextGen HealthCare 

North Shore-LIJ Health System and 

Hofstra North Shore-LIJ School of 

Medicine 

Philips Healthcare 

Poudre Valley Medical Group and Poudre 

Valley Health System 

Practice Fusion 

Premier 

Qualcomm 

Sharp HealthCare 

Siemens Healthcare 

Summit Health Institute for Research and 

Education (SHIRE) 

Tenet Healthcare Corporation 

Tennessee Office of eHealth Initiatives 

Texas Office of eHealth Coordination 

United Health Group 

University of Texas at Houston 

Vanderbilt University School of Nursing 

An Overs:g'it Framework for .Assu'-i:lg Patie:it Safety iii Health Info:-mation Technology I 33 
127 


80806.128

1 Institute of Medicine. (1999). To Err is Human. Washington, D.C.: The National Academies Press. 

, Institute of Medicine. (2001). Crossing the Quality Chasm: A New Health System for the 21" Century. 

Washington, D.C.: The National Academies Press. 

, Institute of Medicine. (2012). Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, 

D.C.: The Nationa! Academies Press, 187. 

4 Food and Drug Administration Safety and Innovation Act of 2012. 

5 Institute of Medicine. (1999). To Err is Human. Washington, D.C.: The National Academies Press. 

'Institute of Medicine. (2001). Crossing the Quality Chasm: A New Health System for the 21" Century. 

Washingtonl D,C.: The Nationa! Academies Press. 

7 Buntin M.B., Burke M., Hoaglin M., and Blumenthal D. (2011). The Benefits of Health Information Technology: A 

Review of the Recent Literature Shows Predominantly Positive Results. Health Affairs, 30(3): 464-471. 

8 Hsiao C. and Hing E. (2012). Use and Characteristics of Electronic Health Record Systems Among Office-based 

Physician Practices: United States, 2011-2011. NCHS Data Brief; 111. HyattSVille, MD: National Center for Health 

Statistics. 

9 DesRoches C.M., Worzala c., Joshi M.S., Kravolec P.D., and Jha A.K. (2012). Small, Nonteaching, and Rural 

Hospitals Continue to be Slow in Adopting Electronic Health Record Systems. Health Affairs,.31(S). 

" Centers for Medicare and Medicare Services. (2012). Summary Report of CMS Medicare and Medicaid EHR 

Incentive Programs through December 2012. 

11 Institute of Medicine. (2012). Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, 

D.C.: The National Academies Press. 

12 Pennsylvania Patient Safety Authority. (2012). The Role of Electronic Health Records in Patient Safety Events. 

13 Food and Drug Administration Safety and Innovation Act of 2012. 

" Buntin M.B., Burke M., Hoaglin M., and Blumenthal D. (2011). The Benefits of Health Information Technology: A 

Review of the Recent Literature Shows Predominantly Positive Results. Health Affairs, 30(3): 464-471. 

15 Institute of Medicine. (2012). Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, 

D.C.: The National Academies Press. 

16 Institute of Medicine. (2012). Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, 

D.C.: The National Academies Press. 

17 Institute of Medicine. (2012). Health IT and Patient Safety: Building Safer Systems for Better Care. Washington, 

D.C.: The Nationa! Academies Press. 

1B Food and Drug Administration Safety and Innovation Act of 2012. 

19 Institute of Medicine. (1999). To Err is Human. Washington, D.C.: The National Academies Press. 

20 International Organization for Standardization. (2012). ISO TR 17791, Health Informatics Technical Report 

Guidance on Standards for Enabling Safety in Health Software. Geneva, Switzerland: International Organization for 

Standardization. 

21 OMB Circular No. A-1l9. 

" OMB Circular No. A-119. 

" National Technology Transfer and Advancement Act of 1995. 

" The Patient Safety and Quality Improvement Act of 2005. 

25 Agency for Health Care Research and Quality. (2012). Agency for Healthcare Quality and Research Web Site: 

PSO FAQs. Accessed January 28, 2013. 

" ECRI Institute. (2012). ECRI Institute PSO Deep Dive: Health Information Technology. Plymouth Meeting, PA: 

ECRI Institute 

27 National Association of State Health POlicy. (2012). 

An Overs:ght Framework for Assuring Patient Safety in Health Information Tec~nology I 34 
128 


80806.129

28 Joint Commission on Accreditation of Healthcare Organizations (2012). Comprehensive Accreditation Manual for 

Hospitals, Update 1, March 2012. JCAHO: Chicago, ll. 

29 The Patient Safety and Quality Improvement Act of 2005. 

30 Agency for Health Care Research and Quality. (2012). Agency for Healthcare Quality and Research Web Site: 

PSO FAQs. Accessed January 28, 2013. 

An Overs:g'1t Framework for Assuri:1g Patient Safety "n Health Info~matjon TeC1:1ology I 35 
129 


80806.130

lOOO 

WViW.BIPARTISA:'IJPOLICY.ORG 
130 

Mr. PITTS. The chair thanks the gentlelady, and now recognizes 

Dr. Classen for 5 minutes for an opening statement. 

STATEMENT OF DAVID CLASSEN 

Dr. CLASSEN. Good morning, Chairman Pitts and Ranking Member Pallone, members of the subcommittee. Thank you for the opportunity to testify on this very important issue. I am a practicing 

infectious disease physician at the University of Utah School of 

Medicine, and I am the Chief Medical and Informatics Officer at 

Pascal Metrics, a patient safety organization. I also chair the 

AHRQ Formats Committee at the National Quality Forum. My 

background is as an infectious disease physician, medical 

informaticist and patient safety researcher. As such, I have been 

on several Institute of Medicine committees that have focused on 

how to improve patient safety, most recently, the one I will draw 

my testimony from today, Health IT and Patient Safety: Building 

Safer Systems for Better Care. One of the focuses of that report 

was how do we improve the safety of care for our patients most effectively with health IT? How do we do it in a way that doesn’t injure our patients or harm them, and how do we do it in a way that 

does not stifle innovation? 

From that report, we looked back through the original To Err is 

Human report from the Institute of Medicine that suggested that 

as many as 98,000 lives a year are lost due to medical errors. In 

our most recent report, we suggest that those estimates of patient 

safety problems are probably lower than is really the story, based 

on newer detection problems both in hospitals and in the ambulatory setting of care. So there clearly is a large opportunity for us 

to use health IT to improve safety of care, both on the inpatient 

setting in hospitals and on the ambulatory setting. 

So one strategy that the Nation has turned to for safer, more effective care is the widespread use of health IT. As we have heard 

from other panel members, this really is the case over the last several years. We are investing billions of dollars in Meaningful Use 

to more broadly adopt this health IT. It is clearly playing an ever 

larger role in the care of patients, and clearly there is evidence that 

it has improved health care and reduced medical errors. 

Continuing to use paper records places patients at unnecessary 

risk for harm and substantially concerns the ability to reform 

health care. However, there are concerns about harm that has 

come from the use of health IT that led to the generation of this 

IOM report. In this IOM report, health IT and patient safety was 

defined broadly to include EHRs, patient engagement tools, personal health records, secure patient portals, health information exchanges, and mobile applications. 

Practicing clinicians, such as myself, expect health IT to support 

the delivery of high quality in several ways, including storing comprehensive health data, providing clinical decision support, facilitating communication, and reducing medical errors. It is widely believed that health IT, when designed, implemented, and used appropriately, can be a positive enabler to transform the way care is 

delivered. Designed and applied inappropriately, health IT can add 

complexities to the already complex delivery of health care, which 

can lead to unintended consequences, for example, dosing errors, 

131 

failing to detect fatal illnesses, and delaying treatment due to poor 

human to computer error, actions or loss of data. Merely installing 

health IT in health care organizations will not result in improved 

care or safety. Taking together the design, implementation, and use 

of health IT affects its performance on improving the safety of care. 

Safe implementation and safe use of health IT is a complex, dynamic process that requires a shared responsibility among vendors, 

health care workers, and health care organizations, a partnership, 

if you will. Many features of software contribute to its safe use, including usability and interoperability, and can also contribute to 

patient safety problems if we have poor user design, poor work 

flow, or complex interfaces, which could be a threat to patient safety. The lack of system operability is clearly a major problem in patient safety. We do have some success stories here. Laboratory 

standards have added—actually facilitated the free flowing of laboratory information. However, we are not there yet and information 

such as problem lists and medication lists are not currently easily 

transmitted between health IT systems. 

Safety considerations need to be embedded throughout the whole 

health IT implementation process, including planning, deployment, 

stabilization, optimization, and transformation. Vendors take primary responsibility for the design and development of technologies 

ideally with iterative feedback from users. The users assume responsibility for safe implementation at work with vendors throughout the health IT implementation process. This partnership to develop, implement and optimize system is a shared responsibility 

where vendors and users help each other achieve the safest possible applications of health IT. 

It is important to recognize that health IT products generally 

cannot be installed out of the box. Users often need to ensure that 

products appropriately match their needs and capabilities in both 

functionality and complexity of operation. So therefore, in operation 

health IT can look very different from what it looked like on the 

shelf. 

Ongoing safe use of health IT requires diligent surveillance of 

evolving needs, gaps, performance issues, and mismatches between 

user needs and system performance, unsafe conditions, and adverse 

events. The IOM report believes certain actions are required by 

both private and public entities to monitor safety in order to protect the public’s health, and provided the following recommendations to improve health IT nationwide. In my testimony, I have the 

recommendations in that report, but in the interest of time, I will 

leave them in the testimony and conclude my remarks. 

Thank you very much. 

[The prepared statement of Dr. Classen follows:] 

132 


80806.035

Testimony of David C Classen, MD, MS 

Before the 

Subcommittee on Health 

Committee on Energy and Commerce 

u.S. House of Representatives 

Hearing on: 

"Health Information Technologies: How Innovation Benefits Patients" 

March 20, 2013 
133 


80806.036

Chairman Pitts and Ranking Member Pallone, Members of the Subcommittee, thank 

you for the opportunity to testify on this very important issue. 

I am a practicing infectious disease physician at the University of Utah School of 

Medicine and I am also the Chief Medical Informatics Officer at Pascal Metrics, a 

federally certified Patient Safety Organization (PSO). I am also Co-Chair of the AHRQ 

Common Formats Committee at the National Quality Forum. 

I am trained as an infectious disease physician and a medical informaticist and also I 

am a patient safety researcher focused on ways to measure and improve patient 

safety with health information technology (health IT). Furthermore I have been a 

member of several Institute of Medicine Committees on patient safety, most recently 

(2010-11) the one whose report I will touch on today, Health IT and Patient Safety: 

Building Safer Systems For Better Care. Indeed much of my testimony is drawn 

directly from this 10M report. 

More than a decade ago, the Institute of Medicine (10M) report, To Err Is Human, 

estimated that 44,000-98,000 lives are lost every year due to medical errors in 

hospitals and led to the widespread recognition that health care is not safe enough, 

catalyzing a revolution to improve the quality of care. Despite considerable effort, 

patient safety has not yet improved to the degree hoped for in that 10M report. In 

the most recent 10M report on Health IT and Patient Safety, the estimates of patient 

safety problems in hospitals are much higher than the original estimates more than 
134 


80806.037

a decade ago, similar studies of ambulatory patient safety issues from the American 

Medical Association and others cited in this 10M report also suggest that original 

estimates of safety problems in the outpatient arena may also be low as well. 

One strategy the nation has turned to for safer, more effective care is the 

widespread use of health IT. The U.S. government is investing billions of dollars 

toward meaningful use of effective health IT so that all Americans can benefit from 

the use of electronic health records (EHRs). Health IT is playing an ever-larger role 

in the care of patients, and some components of health IT have significantly 

improved the quality of health care and reduced medical errors. Continuing to use 

paper records can place patients at unnecessary risk for harm and substantially 

constrain the country's ability to reform health care, However, concerns about harm 

from the use of health IT have emerged. 

In this 10M report on Health IT and Patient Safety, health IT is defined broadly to 

include a broad range of products, including EHRs, patient engagement tools (e.g., 

personal health records [PHRs] and secure patient portals), and health information 

exchanges (HIEs). Included in this definition of HEALTH IT were mobile applications 

of any of these tools listed above. 

Practicing clinicians such as myself expect health IT to support delivery of highquality care in several ways, including storing comprehensive health data, providing 

clinical decision support, facilitating communication, and reducing medical errors. 
135 


80806.038

It is widely believed that health IT, when designed, implemented, and used 

appropriately, can be a positive enabler to transform the way care is delivered. 

Designed and applied inappropriately, health IT can add complexity to the already 

complex delivery of health care, which can lead to unintended adverse 

consequences, for example dosing errors, failing to detect fatal illnesses, and 

delaying treatment due to poor human-to-computer interactions or loss of data. 

Software-related safety issues are often ascribed narrowly to software coding errors 

or human errors in using the software. It is rarely that simple. Many problems with 

health IT relate to usability, implementation, and how software fits with clinical 

workflow. Focusing on coding or human errors alone often leads to neglect of other 

important factors (e.g., usability, workflow, interoperability, human factors for 

example) that may increase the likelihood a patient safety event will occur. Safety is 

an emergent property of a larger system that takes into account not just the 

software but also how it is used by clinicians. That larger system - often called a 

sociotechnical system - includes technology (e.g., software, hardware), people (e.g., 

clinicians, patients), processes (e.g., workflow), organization (e.g., capacity, 

decisions about how health IT is applied, incentives), and the external environment 

(e.g., regulations, public opinion). Adopting a sociotechnical perspective 

acknowledges that safety emerges from the interaction among these various factors. 

Merely installing health IT in health care organizations will not result in improved 

care or safety. Taken together, the design, implementation, and use of health IT 
136 


80806.039

affects its safety performance. Safe implementation and safe use of health IT is a 

complex, dynamic process that requires a shared responsibility among vendors, 

health care workers, and health care organizations. Safely functioning health IT 

should provide easy entry and retrieval of data, have simple and intuitive displays, 

and allow data to be easily transferred and shared among health professionals. 

Many features of software contribute to its safe use, including usability and 

interoperability. The committee believes poor user-interface design, poor workflow 

and complex data interfaces are threats to patient safety. The lack of system 

interoperability is a barrier to improving clinical decisions and patient safety, as it 

can limit data available for clinical decision-making. Laboratory data have been 

relatively easy to exchange because good standards exist such as Logical 

Observation Identifiers Names and Codes (LOIN C) and are widely accepted. 

However, important information such as problem lists and medication lists are not 

easily transmitted and understood by the receiving health IT product because 

existing standards have not been uniformly adopted. Interoperability must extend 

throughout the continuum of care; standards need to be developed and 

implemented to support interaction between health IT products that contain 

disparate data. 

Safety considerations need to be embedded throughout the whole health IT 

implementation process, including the stages of planning and goal setting, 
137 


80806.040

deployment, stabilization, optimization, and transformation. Selecting the right 

software requires a comprehensive understanding of the data and information 

needs of the organization and the capabilities of the system. Vendors take primary 

responsibility for the design and development of technologies, ideally with iterative 

feedback from users. Users assume responsibility for safe implementation and work 

with vendors throughout the health IT implementation process. The partnership to 

develop, implement, and optimize systems is a shared responsibility where vendors 

and users help each other achieve the safest possible applications of health IT. 

It is important to recognize that health IT products generally cannot be installed out 

of the box. Users often need to ensure that products appropriately match their 

needs and capabilities- in both functionality and complexity of operation. The 

process of implementing and supporting software is critical to optimizing value and 

mitigating patient safety risks. A constant, ongoing commitment to safety-from 

acquisition to implementation and maintenance-is needed to achieve safer, more 

effective care. Testing at each of these stages is needed to ensure successful and safe 

use of health IT. 

Ongoing safe use of health IT requires diligent surveillance of evolving needs, gaps, 

performance issues, and mismatches between user needs and system performance, 

unsafe conditions, and adverse events. The committee believes certain actions are 

required by private and public entities to monitor safety in order to protect the 

public's health and provides the following recommendations to improve health IT 

safety nationwide-optimizing their use to achieve national health goals, while 
138 


80806.041

reducing the risks of their use resulting in inadvertent harm. 

Building on this background, the 10M report on Health IT and Patient Safety made a 

series of recommendations summarized as follows: 

Recommendation 1: The Secretary of Health and Human Services (HHS) should 

publish an action and surveillance plan within 12 months that includes a schedule 

for working with the private sector to assess the impact of health IT on patient 

safety and minimizing the risk ofits implementation and use. 

Recommendation 2: The Secretary of HHS should ensure insofar as possible that 

health IT vendors support the free exchange of information about health IT 

experiences and issues and not prohibit sharing of such information, including 

details (e.g., screenshots) relating to patient safety. 

Recommendation 3: The Office of The National Coordinator for Health IT (ONC) 

should work with the private and public sectors to make 

comparative user experiences across vendors publicly available. 

Recommendation 4: The Secretary of HHS should fund a new Health IT Safety 

Council to evaluate criteria for assessing and monitoring the safe use of health IT 

and the use of health IT to enhance safety. This Council should operate within an 

existing voluntary consensus standards organization. 

Recommendation 5: All health IT vendors should be required to publicly register 

and list their products with ONC, initially beginning with EHRs certified for the 

meaningful use program. 

Recommendation 6: The Secretary ofHHS should specify the quality and risk 

management process requirements that health IT vendors must adopt, with a 

particular focus on human factors, safety culture, and usability. 

Recommendation 7: The Secretary of HHS should establish a mechanism for both 

vendors and users to report health IT -related deaths, serious injuries, or unsafe 

conditions. 

Recommendation 8: The Secretary of HHS should recommend that Congress 

establish an independent federal entity for investigating patient safety deaths, 

serious injuries, or potentially unsafe conditions associated with health IT. This 

entity should also monitor and analyze data and publicly report results of these 

activities. 

Recommendation 9a: The Secretary of HHS should monitor and publicly report on 

the progress of health IT safety annually beginning in 2012. If progress toward 

safety and reliability is not sufficient as determined by the Secretary, the Secretary 
139 


80806.042

should direct the FDA to exercise all available authority to regulate EHRs, health 

information exchanges, and PHRs. 

Recommendation 9b: The Secretary should immediately direct the FDA to begin 

developing the necessary framework for regulation. Such a framework should be in 

place if and when the Secretary decides the state of health IT safety requires FDA 

regulation as stipulated in Recommendation 9a above. 

Recommendation 10: HHS, in collaboration with other research groups, should 

support cross-disciplinary research toward the use of health IT as part of a learning 

health care system. Products of this research should be used to inform the design, 

testing, and use of health IT. Specific areas of research include 

a. User-centered design and human factors applied to health IT; 

b. Safe implementation and use of health IT by all users; 

c. Sociotechnical systems associated with health IT; and 

d. Impact of policy decisions on health IT use in clinical practice. 

Thank you and I look forward to answering your questions. 
140 


80806.043

References 

Institute of Medicine. To Err Is Human: Building a Safer Health System. Washington, 

DC: National Academy Press, 2000. 

Institute of Medicine. Health IT and patient safety: Building safer systems for better care. 

20 I I. http://www.iom.edu/Reports/201 I /Health-IT -and-Patient-Safety-Building-SaferS ystems-for-Better-Care.aspx 
141 

Mr. PITTS. The chair thanks the gentleman. 

Let me ask—start a question. I recognize myself for 5 minutes 

for this purpose. I will ask each of you this question. 

Do you believe that data, Dr. Smith, for the purposes of regulation should be classified as a medical device? 

Dr. SMITH. Data, no, sir. 

Mr. PITTS. Ms. Bechtel? 

Ms. BECHTEL. I have to say this is not my area of expertise. 

Mr. PITTS. Mr. Bialick? 

Mr. BIALICK. Data, no. 

Mr. PITTS. Dr. Mitus? 

Dr. MITUS. Data per se, no. 

Mr. PITTS. Dr. Classen? 

Dr. CLASSEN. Data, no. 

Mr. PITTS. Thank you. 

Now, Mr. Bialick, do you believe that the newborn patients you 

are here representing today will be best served by the FDA 

classifying medical apps as medical devices? 

Mr. BIALICK. As the draft guidance is written, no. 

Mr. PITTS. Speaking of the FDA draft guidance, many have argued that the FDA is proposing to only regulate apps that are essentially medical devices and does not intend to go any further. 

And while I may disagree with this presumption, I do think it is 

very instructive for the purposes of today’s hearing. Many years of 

dealing with the FDA have taught me that it is not what they say 

they are going to regulate today, but what they could regulate tomorrow. 

Are you familiar—I will stay with you, Mr. Bialick—with the 

term regulatory creep? 

Mr. BIALICK. I am. 

Mr. PITTS. And what could regulatory creep mean for a combination who seek to innovate in this space and to the patients whose 

lives may depend upon this innovation for their health and welfare? 

Mr. BIALICK. The draft guidance, as it was written, I think refers 

or relies on terminology like an app that even now is a little bit 

outdated. The concept of an app is a discreet piece of software on 

a device. That is really being changed by how the market has embraced cloud technology. The idea that you would have a discreet 

piece of an app or software that is one little piece, that is different 

now when an app is also the browser on your smartphone. These 

technologies are becoming platform agnostic, and so how do we talk 

about that in reference of, when the draft guidance was written, 

even the definition of an app has changed during this time, so the 

idea that we can regulate an app—but these apps are expanding, 

we need to have clearer lines as to how these things are—where 

the regulation is going to stop. 

Mr. PITTS. OK. Well, let me ask, and each of you can respond. 

Do you believe the FDA has the expertise to regulate medical app 

technology, and do you foresee them gaining that expertise in the 

foreseeable future? Let’s just start and go down the line. Dr. 

Smith? 

Dr. SMITH. I think it is, to a point in my testimony, making sure 

that regulation moves at the speed of innovation. I think it is quite 

142 

challenging for the FDA and for many reasons to stay as current 

as possible on those things which are simply just emerging. And so 

the simple answer to your question is no. I think the opportunity 

for external expertise needs to be exploited much more thoroughly 

than it has been to date. 

Mr. PITTS. Mr. Bialick? 

Mr. BIALICK. I think that the FDA absolutely has the experience 

and knowledge in-house to evaluate apps that are actually medical 

devices. When it talks about just some of these apps that are connecting, sharing information on networks, then no, they don’t have 

the regulatory expertise in-house. 

Mr. PITTS. Dr. Mitus? 

Dr. MITUS. Concur with my colleagues. Today, the FDA plays a 

very, very important role in health care. McKesson has many solutions that are regulated by the FDA, whose expertise really is in 

the regulation of medical devices. Health IT, we believe, it really 

requires a different paradigm that is not well-suited to the current 

infrastructure and process under the FDA. It is less about the organization and more around the process. 

Mr. PITTS. Dr. Classen? 

Dr. CLASSEN. Just citing from the IOM report, the IOM said that 

if the FDA were to get further involved in the oversight of HIT beyond medical devices, a new framework to do that should be created. 

Mr. PITTS. OK. Now Mr. Bialick, can you share any real world 

examples of patient’s lives being changed through the application 

of new medical technologies? 

Mr. BIALICK. Absolutely. I think, from my own experience that 

I can talk to you with our spread of legislation around congenital 

heart defect screening, like I said, not everybody is born in a city 

center so access to some of these remote home monitoring devices 

is very functional. Not only that, but the telemedicine capacity that 

we are seeing, especially through some of these devices, is really 

expanded. Someone said in the hearing yesterday, it is the new 

house call, and that is absolutely true. We want to keep making 

sure that these devices are getting to the patients that need them. 

Mr. PITTS. My time is expired. Chair recognizes the ranking 

member for 5 minutes for questions. 

Mr. PALLONE. Thank you, Mr. Chairman. 

I wanted to ask some questions of Ms. Bechtel. You testified before this subcommittee in July, 2010, in the early days of the 

HITECH Act and the Meaningful Use Program, and at that point, 

the program was just getting off the ground and we heard estimates from CMS that between 21 percent and 53 percent of the eligible providers would adopt EHRs by 2015, and we have come a 

long way since then. As of February, 2013, 2 years before the 2015 

deadline, CMS data shows that more than 70 percent of eligible 

providers have registered and nearly 40 percent have already successfully completed the first phase of Meaningful Use. The data for 

hospitals is even more promising. Eighty-five percent of those that 

are eligible have registered, and more than 70 percent are Meaningful Users today. So Ms. Bechtel, these adoption rates have exceeded expectations, if you would confirm or talk about that, and 

are we just seeing providers purchase an EHR to check a box or 

143 

are we actually seeing real Meaningful Use, and then finally, other 

than adoption of EHRs, what other signs of progress do you see? 

I will throw those all into one question. 

Ms. BECHTEL. Great. Thank you so much, Congressman. 

Yes, I think it is really remarkable that we have made the 

progress that we have, and it is a testament to the hard work of 

health care providers and vendors, and the regional extension centers who are helping primary care doctors and critical access hospitals every day to adopt and to implement and really use EHRs 

in a meaningful way. I think there are some terrific additional 

signs of progress, like the fact that in 2006 there were almost no 

e-prescribers, which is really key to eliminating handwriting errors. 

It creates an enormous amount of efficiency for consumers and 

their families, and today there are more than a half million. So 

there is really some amazing work that has been done, and I think 

number one, it is the key to helping us get to this system we all 

want through payment reform, and getting there faster, and number two, we have to keep up the pace and we have to keep up the 

progress. The design of the Meaningful Use Program is such that 

in the beginning, providers are adopting and they are beginning to 

implement and use it in some ways like I outlined in my testimony 

that are very meaningful to patients and families. But as they stay 

in the program, it is designed to create even more capabilities that 

benefit patients and families, improve quality, and lower costs, and 

so future stages will deliver even more societal benefits. I think the 

key now is just keeping up the pace. 

Mr. PALLONE. All right, let me ask you another question about 

the mobile apps. I am afraid this hearing is really missing the forest for the trees when it comes to the government’s role in the 

growth of mobile apps and health information technology. Far from 

inhibiting the growth of mobile health applications, the Administration has taken unprecedented steps to open up federal data to 

app developers and coders, and this public-private collaboration 

has led to extraordinary growth in the mobile health application 

space. One example is iTriage, an application created using HHS 

data that helps consumers locate nearby health care providers. The 

app has over three million downloads from the iTunes store, far 

from being slowed down by the Federal Government. If iTriage and 

scores of other apps have grown and they have grown enormously 

because of cooperation and openness of the Federal Government. So 

if you could just tell us about how open government data has contributed to the growth of mobile medical apps, and what that has 

meant for patients. 

Ms. BECHTEL. Yes, I think this is a terrific example of federal 

leadership that is really driving innovation. Three years ago, HHS 

launched the Open Health Data Initiative. They created a Web site 

called healthdata.gov, and if you think about the absolute richness 

of health data that HHS as an agency has, it is really phenomenal, 

whether it is FDA or CDC or NIH or even CMS. And so the model 

for this work was actually NOAA, the National Oceanic and Atmospheric Administration, where once NOAA began to release their 

weather data publically, we use it in weather forecasts on television, we have it on our smartphones, and so the innovation that 

occurred is really the model for opening up health data. The Blue 

144 

Button functionality that I talked about earlier is a great example. 

That was one of the first initiatives of the open health data effort, 

and application developers have taken what is claims data—it is 

not even the rich clinical data from EHRs yet, but it will be next 

year. They have taken the claims data and built applications that 

enable consumers to view their own health information online, but 

also now, the next step is that they are going to automate it so that 

I, as a consumer, can decide that I want an automatic feed anytime 

there is new data, and I can say I would like you to also send it 

to my primary care doctor. So when we talk about care coordination, which is so essential to consumers, this is a great innovation 

and they have held more than 20 code-a-thons where application 

developers and entrepreneurs and different communities have come 

together to create applications in real time using HHS health data 

that are really making a difference. U.S. News and World Reports 

uses it in their health insurance, their best health insurance plans. 

Health Grade uses it to help consumers pick the best health care 

providers out there. So there is really no limit to the innovation 

that I think can occur, because of the collaboration with the Federal Government and entrepreneurial innovators. 

Mr. PALLONE. Thank you. 

Mr. PITTS. Chair thanks the gentleman and now recognizes the 

vice chairman, Dr. Burgess, for 5 minutes for questions. 

Mr. BURGESS. Thank you, Mr. Chairman. Well, it begs the question then, is there going to be an app for the regulatory apps, and 

I guess that is what we are here to answer today. 

Dr. Smith, you brought up an intriguing issue about—when 

speaking about electronic health records and I guess Meaningful 

Use and where outcomes, not location actually ought to be considered. I had a physician in the office this morning, a gastroenterologist who said look, I got a problem. I have got an EHR in 

my office, I use it and it meets all the criteria for Meaningful Use. 

I go to the ambulatory surgery center. I access the same record online and use it, but because I am in an ambulatory surgery center, 

it does not count toward Meaningful Use, and in fact, if I spend 

more than 50.01 percent of my time in the surgery center, which 

is where I spend my time because I am doing procedures on patients who need them, then suddenly I fall out of the criteria to 

meet the criteria for Meaningful Use. Is that what you were referring to where you said outcome, not location? 

Dr. SMITH. It is in part that. It is also the notion that until we 

realize that it is all about the outcome and really irrelevant about 

how we get to that outcome, we will drive rather bizarre behavior, 

and so when one thinks about telemedicine and the opportunity 

to—— 

Mr. BURGESS. He is a gastroenterologist. Bizarre behavior goes 

with the territory. I am sorry, go ahead. 

Dr. SMITH. So I am a cardiologist, and I resemble that remark. 

Until we focus entirely on the outcome, we will drive—first incentive will drive instead of taking care of patients at a distance 

and keeping them on the straight and narrow, we will facilitate the 

system we have had, which is one of really emergency rescue as opposed to health care. 

145 

And so I think with respect to information flow, it has to be 

seamless. With respect to the burden of chronic disease that we 

have in this country, the notion that we are best off taking care 

of folks only when they show up in the emergency room or in the 

doctor’s office is clearly wrong-headed when those patients need the 

kind of day-to-day iterative care that some of these remote technologies and integrated interoperable systems can provide. And so 

that is really the point of that comment. 

Mr. BURGESS. Now there is a difference between what a lot of us 

would consider traditional medical advice, and an app. I mean, an 

intercardiac defibrillator, a traditional medical device, can you sort 

of delineate the difference there for us? 

Dr. SMITH. Oh, absolutely. So, I spent much of my life in either 

the implementation or even design of implantable defibrillators, 

and the company I was working for at the time kind of led a charge 

in making sure that that information that is resonant in those devices could get back to doctors wherever they were when it was 

most needed, instead of using the patient as a vehicle for bringing 

that information back to see you in the office. And so there is a 

huge difference between the one-to-one patient encounter that you 

can have—and I will point out that you can now have technology 

mediated encounter versus the information that you can get on the 

web. I mean, so whether it is an app or whether it is the web, those 

are really quite different things. And so I think as a physician 

yourself, you would realize the important differences. 

Mr. BURGESS. Well, and the ownership of that data is important 

as well, and when we talk about an HHS Web site, but that is, at 

least in theory, the identified data, but you are talking about data 

that is specific to that patient, specific to that patient encounter. 

Dr. SMITH. Absolutely. 

Mr. BURGESS. Dr. Mitus, I was fascinated by your testimony. I 

remember a few years ago in the middle of the chaos of the Haitian 

earthquake, it was either on CNN or reading a Time magazine article where a doctor who was not an OB doctor was helping take 

care of a pregnant woman after the earthquake. She had a hypertensive crisis. His reflex action was to reach for an angiotensin converting enzyme inhibitor, but he looked it up on his mobile app and 

found that that was contraindicated in pregnancy and used something else. I think the story had a happy outcome, but it certainly 

underscores the power of having that medical information at your 

fingertips, and you just go into the app store—even as we sat—not 

that I wasn’t paying rapt attention to all of the testimony, but you 

can download Harrison’s Principles of Internal Medicine. You can 

download the Merck Manual. You can download the Washington 

Manual, and have that literally at your fingertips in as odd a place 

as a congressional hearing. 

So how does the regulatory environment affect that? 

Dr. MITUS. I completely concur that health IT has really revolutionized our ability to provide timely and safe care to patients in 

ways that that we could never have envisioned even 10 years ago. 

The power of technology enables us and is very different than a 

medical device. I believe, though, there is an important distinction, 

to return to your prior question. A device, in our mind, sits directly 

connected to a patient and has automation that allows it to indeVerDate Nov 24 2008 13:42 Sep 13, 2013 Jkt 037690 PO 00000 Frm 00151 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-21 CHRIS
146 

pendently act upon that patient. It is really replacing that human 

judgment. Whereas a physician who intervenes and accesses medical guidelines, such as a textbook online or receives an alert to potentially prevent a fatal drug interaction is allowed to use their 

own common sense and judgment, and that is fundamentally different than a device. 

Mr. BURGESS. But the FDA looks at it as decision support, so 

therefore, it is open to regulation. Is that correct? 

Dr. MITUS. That is our understanding, and we believe a risk. 

Mr. BURGESS. Thank you, Mr. Chairman. I will yield back. 

Mr. PITTS. Chair thanks the gentleman and now recognizes the 

ranking member of the full committee, Mr. Waxman, for 5 minutes 

for questions. 

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

Dr. Mitus, as I understand, you are a hematologist/oncologist. Is 

that right? 

Dr. MITUS. Correct. 

Mr. WAXMAN. OK. So let’s say you had software that could— 

claims to diagnose a mole and whether it is melanoma or not. Do 

you think the FDA ought to regulate that? 

Dr. MITUS. That is a very interesting question, and one that I 

pondered last night after you asked that yesterday. I actually 

looked up Dr. Mole online to understand, as I was not familiar with 

that technology. I think that really delineates the challenge that 

we have before us. What a wonderful piece of technology—— 

Mr. WAXMAN. Excuse me. I really have a limited time. Do you 

think it ought to be regulated by the FDA or FDA ought to review 

it before it is widely used? Yes or no. 

Dr. MITUS. I believe that there is risk and there is intelligence 

in that application, as I understand it, and it is—should be considered a high risk piece of software, and we believe in a risk-based 

system and it could potentially be regulated by the FDA, much the 

way mammography software is today. 

Mr. WAXMAN. OK. Now you raised a bunch of points in your testimony, and you pose a number of questions. Should an iPad application that helps track the number of steps you walk per day be 

regulated as a medical device, and FDA says no in their guidance. 

You asked if it is a reminder time to refill a prescription. FDA’s 

guidance said no, that is not a medical device. You asked a question whether digital versions of a physician’s desk reference would 

be subject to regulation, and FDA says no. Those are not going to 

be subject to regulation. So I found it puzzling, because FDA addressed them specifically in their draft guidance, a specific list of 

these examples of what should not be regulated. Is your concern 

that FDA is going to change its mind and regulate it? 

Dr. MITUS. My concern is that there is a spectrum of capabilities 

that is increasingly delivered through technology, whether on a mobile app or on a desktop, and that gray area as we just described, 

the ability for a doctor to receive an alert or a warning is not something in my mind that should be regulated as a medical device. 

Mr. WAXMAN. Well, I can understand that point of view but you 

would see the point of view that some things ought to be regulated 

as a medical device, wouldn’t you? 

147 

Dr. MITUS. Medical devices certainly should be regulated as medical devices. 

Mr. WAXMAN. Well, there is a judgment to be drawn. My colleague said well, that judgment ought to be up to Congress. Do you 

think Congress should make those distinctions, or should it be the 

FDA or some government regulatory agency that has some expertise on these kinds of issues? There is a line to be drawn. Who 

should draw that line? 

Dr. MITUS. It is a difficult line to be drawn. I am not—I won’t 

presume to be able to tell you who should draw that line. What we 

would like to point out—— 

Mr. WAXMAN. Well, knowing that it is difficult doesn’t help. Who 

should draw the line? There is some that should be regulated as 

medical devices and some shouldn’t. I agreed with your testimony. 

Those things that are informational based shouldn’t be regulated, 

and FDA agrees with that, but there are some that ought to be diagnosed. 

Mr. Bialick, there is a device that remotely monitors infants with 

congenital heart defects using a pulse oximeter. Pulse oximeters 

monitor the oxygen saturation of a patient’s blood, and especially 

in the case of newborns with congenital heart defects, they are a 

critical tool to monitor cardiac health. This is obviously a sensitive 

and important device. If the device provides the wrong reading or 

provides faulty information, it can lead to disastrous results. Do 

you believe that FDA should play a role in ensuring that these 

types of devices are safe and effective? 

Mr. BIALICK. That is why FDA does evaluate pulse oximeters. 

Mr. WAXMAN. And you think that is appropriate? 

Mr. BIALICK. Pulse oximeters as medical devices, yes. The app 

that has the potential to connect to a covered device, that is a different story because it is not a traditional medical device. You are 

talking about medical software at that point. So I would like to talk 

about drawing the delineation here. That is the delineation I would 

like to make. 

Mr. WAXMAN. Well, the app transmits the information, but the 

information is based on this pulse oximeter. 

Mr. BIALICK. Right, and—— 

Mr. WAXMAN. And the pulse oximeter ought to be reviewed by 

the FDA because if it is giving false information, it can have serious consequences, right? 

Mr. BIALICK. I agree. Medical devices should be evaluated by the 

FDA. 

Mr. WAXMAN. So say, Dr. Mitus—— 

Mr. BIALICK. I am sorry. 

Mr. WAXMAN. I am switching to Dr. Mitus. If somebody takes a 

picture of a mole and they say don’t worry, you don’t have cancer, 

and they are wrong, that is a serious disaster waiting to happen. 

We need somebody other than members of Congress to say that 

ought to be regulated, and the law requires, I think, FDA appropriately to regulate it. 

My point to all of you is there is a distinction that has to be 

made, and the points you raised, Dr. Mitus, were all scary things 

that just aren’t being considered for regulation, and FDA has been 

very explicit about it. So I am somewhat disappointed that you 

148 

would say these things are going to be regulated when FDA says 

they have no intention of regulating them, and so that is why I 

asked do you think FDA is going to reverse its stand. Is that what 

you are worried about? 

Mr. PITTS. You may respond. 

Mr. WAXMAN. To Dr. Mitus, are you worried the FDA is going to 

change its mind and suddenly regulate those things? 

Dr. MITUS. We are worried that there is a large gray area of 

medical health IT that could be subject to regulation. 

Mr. PITTS. Mr. Bialick, you wanted to say something? 

Mr. BIALICK. To your point, Mr. Waxman, you said is this 

Congress’s decision to make this or is this FDA’s decision or is this 

another agency? I would like to say that this is such a big issue 

and such a dynamic market that no one entity should be making 

these decisions. There is a clear need for a framework of experts 

to convene to talk about what is going on at FDA, what is going 

on at ONC, what is going at FCC, especially as these things consider mobile apps, as well as what Congress’s role is in regulating 

that? So the framework, absolutely Congress has a role. Congress 

has a role to develop this framework. 

Mr. WAXMAN. Well, FDA is required to bring in a group like that 

and give them guidance, but if you are giving an amorphous group 

to look at it with nobody having clear responsibility, nothing is 

going to happen and that is a very dangerous thing if a device can 

do harm. 

My time is expired. 

Mr. PITTS. The chair thanks the gentleman and recognizes the 

gentleman from Illinois, Mr. Shimkus, for 5 minutes. 

Mr. SHIMKUS. Thank you, Mr. Chairman. I enjoy following Mr. 

Waxman, who is obviously very thoughtful. We had part of this debate yesterday in the other hearing, and I think—and I am going 

to go off script just because Mr. Bialick, on this pulse oximeter— 

I am not a health care guy but I did read it in your testimony— 

your point is that that device is a taxed and monitoring. So as I 

was trying—you are trying to say that data is being formed by the 

medical device as certified. The transmission of that data to a 

handheld device is a concern, especially if it gets classified as a 

Tier III medical device. 

Mr. BIALICK. Absolutely. 

Mr. SHIMKUS. What happens if it gets classified as a Tier III 

medical device? 

Mr. BIALICK. It would be evaluated as such through the FDA 

process. 

Mr. SHIMKUS. And what else happens to it? 

Mr. BIALICK. It gets pulled off the market. It has to go through 

the entire process. I mean—— 

Mr. SHIMKUS. And what else happens to it? It gets a big freaking 

tax on it, a gross tax, not a net tax. So anyway, it is always exciting to be on this committee with my friend from California. 

Because we talked about the chips and the shoes, too. Obviously 

for general fitness, just measuring steps, no, but what if that is a 

device that has been prescribed? 

Mr. BIALICK. Another case. 

149 

Mr. SHIMKUS. And my friend, Mr. Pallone, mentioned HHS 

health and one app. Good for them. How many apps are there? 

Ninety-seven thousand apps. How are the other 96,999 developed? 

By the private sector, by individual capital, by people assuming 

risk. I pulled this up—pull up your page. How many new apps are 

there to change your app? Notifications, you got to update your 

app. What happens if this whole process falls into that? So now you 

have an app, it has had technical problems, maybe it is a Tier II 

and now you want to update the app. Does that have to go back 

through the entire process again? These are very, very important— 

they belittle—the fact that we are having these questions, but the 

fact that we are having these questions means that we don’t have 

answers. 

So what does FDA do when they go to the Institute of Medicine, 

right, they commission a report, which they did on MDUFA, and 

they kind of follow that a lot of times. Well, what did the Institute 

of Medicine just come out on this? Well, one member disagrees 

with the committee and would immediately regulate health IT as 

a Class III medical device as outlined in Appendix E. So they are 

saying all health IT—or this guy, this one respondent says this 

should be, and there is a fear about that, is there not, because of 

the things we issued before. 

So Mr. Bialick, if FDA regulated health IT as medical devices, 

would they be subject to the device tax as written in law? 

Mr. BIALICK. I default to Congress on that. 

Mr. SHIMKUS. I already asked that. The answer is yes. What 

could this mean for patients, especially for telemedicine and other 

advancements that are starting to improve the quality and access 

to care for patients in rural areas, like my district, who are sometimes hours away from the care they need? 

Mr. BIALICK. It is a very important question. I think that as telemedicine develops, we are starting to also see a development of our 

networks of care. So it is not just we go to the one rural doctor that 

we have access to—— 

Mr. SHIMKUS. Right. 

Mr. BIALICK [continuing]. But rather, we have access to many 

professionals. 

Mr. SHIMKUS. Anybody else want to jump in real quick on this? 

Dr. MITUS. I believe it could significantly delay and put at risk 

the deployment—— 

Mr. SHIMKUS. Here is what I observed in my district. I have a 

large rural district. There are 102 counties in the State of Illinois. 

I represent 33. Where a lot of hospitals are moving to is obviously 

nurses on site, doctors at computer screens monitoring the real 

data, and also what they can do is—so the nurse says doc, calls 

him up, Doc, check this patient X. So they go into the room, the 

patient is laying there and he will have the nurse open up the eyelid and the camera will zoom in on the eye to make a determination. Now if you follow this debate, now you have got data flowing 

over in a picture form, i.e., like the mole debate, but it is a camera 

in essence taking a real time picture. How does that get regulated? 

And if it, as my colleague from California said, if that should be 

a Tier III because then do I not have the access to real time picture 

150 

of the pupil of a patient, and an immediate doctor intervention, 

versus calling one from 20 miles away? 

My time is expired. I thank you all and I yield back my time. 

Mr. PITTS. Chair thanks the gentleman, and now recognizes the 

gentlelady from Virgin Islands, Dr. Christensen, for 5 minutes for 

questions. 

Mrs. CHRISTENSEN. Thank you, Mr. Chairman, and thank you to 

the panelists for being here this morning. I am sorry I missed yesterday’s hearing. 

But this hearing—this series of hearings is centered on the relationship between innovation and public—and patient safety, and I 

think the Meaningful Use EHR program is a great example of how 

government can promote technological innovation that has the potential to significantly improve patient care. 

Phase one of the program already enables providers to maintain 

up-to-date electronic lists of the health conditions, diagnoses, medication, and medication allergies. They can automatically check for 

drug interactions and drug allergies, as we have heard, and have 

the ability to send prescriptions electronically to a patient’s pharmacy, reducing wait time and eliminating handwriting errors. 

Ms. Bechtel, can you give us some information about—some more 

information about how electronic health records are already helping to improve patient care, and how future phases of Meaningful 

Use advance our ability to improve that care, and would you add 

into your answer how it—how HIT—the role it can play in eliminating health disparities? 

Ms. BECHTEL. Absolutely. So let me start with health disparities, 

because I actually think that that is one of the ways that the 

Meaningful Use Program is making a real difference for patients 

and families. 

In the first stage of Meaningful Use, there were a couple of 

things that were really important to help disparities. One was collecting better and more granular data about race, ethnicity, language, and gender, because those are categories where we see vulnerable populations and the greatest amount of health disparities, 

as you know. And so we have now created the ability to collect information like that in a standardized way, and when you do that 

in a computer system, you can then stratify other information by 

those data types to identify disparities, and the first step in eliminating them has to be identifying them. We also created a capability for electronic health records to report quality measurement, 

and which is key to payment later, and so the ability to look at the 

kind of care that you are providing for different populations that 

you are serving is really instrumental, and that was not standardized prior to Meaningful Use. 

In future stages as well, we are going to see things like a population health dashboard that is going to allow you to look at multiple populations. My hope is that, well into the future we will see 

things like more advanced intelligence systems that will look for 

disparities that we didn’t even know to look for, for example. So 

there are some really terrific things. 

I think I would say that in terms of what is happening today already right now, the Commonwealth Fund, an independent organization, looked at several different hospitals and they concluded 

151 

that health IT adoption has led to faster, more accurate communications, streamlined responses that have improved patient flow. 

It has reduced duplicative testing and sped up responses to patient 

inquiries, and that has been really phenomenal. 

Yesterday there was a study released by the Quest Collaborative, 

which Premiere reads, and it is really an indication of what can 

happen when you blend not just the health IT infrastructure that 

the Quest hospitals have, but the quality measurement and the 

public reporting and the payment and all of these things that have 

bipartisan support, they saved 92,000 lives and $9.1 billion over 

41⁄2 years. 

Mrs. CHRISTENSEN. Let me try to get another question in. You 

sat on the Federal HIT Policy Committee and you reported that 70 

percent, I think, of physicians are utilizing HIT, but have you seen 

the adoption in minority practices, practices in rural and poor communities, and if so, if not, is that a concern and is the committee 

doing anything to address that? 

Ms. BECHTEL. Yes, and I think that is also a great question for 

federal officials tomorrow as well. But yes, we are. So 40 percent 

of rural primary care providers are working with regional extension 

centers and are therefore more likely to achieve Meaningful Use, 

so that is really good news. In terms of providers serving vulnerable populations, many of them will receive payments under the 

Medicaid program, and every State has, in fact, designed and has 

begun to implement their programs, and that is really the first step 

to make sure. 

So I think there is very good news, but it is something we must 

continue to monitor. 

Mrs. CHRISTENSEN. OK, thank you. I guess I will yield back the 

balance of my time. I don’t—— 

Mr. PITTS. Chair thanks the gentlelady and now recognizes the 

gentleman from Texas, Mr. Hall, 5 minutes for questions. 

Mr. HALL. Mr. Chairman, I would like to use part of my time 

thanking you for bringing this up. It is something I am very, very 

interested in. I would ask Mr. Bialick, I guess—I hope I pronounced it right. I don’t believe anyone has got around to the 

newborns. If they have, I will wait and write—and ask for written 

testimony. 

But if not, Mr. Bialick, a lot of us remember the sleepless nights 

and exhausting routines that go along with a newborn at home, 

and if we are blessed with a child without medical problems, we 

have sleepless nights also but not like others. Can you share with 

the committee the additional challenges and/or stresses of medical 

problems and how technology can be utilized to make their lives 

better, or—let me shorten it. How do you envision mobile medical 

technology devices being used to improve care for newborns, and if 

these technologies are subject to a lengthy bureaucratic approval 

process, how will that impact patients and families? Because if 

they apply or register when their newborns are newly born, they 

won’t be newborns when they get around to them. 

Mr. BIALICK. Sure. Thank you for that question. Babies with congenital heart defects are super users of the health care system. 

They are not only going to be using imaging services very early, 

they are going to need, in critical cases, either immediate intervenVerDate Nov 24 2008 13:42 Sep 13, 2013 Jkt 037690 PO 00000 Frm 00157 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-21 CHRIS
152 

tion, maybe surgically, and then follow-up care with additional imaging throughout their lives. 

Now, it happens to be that, like I said, not all babies are born 

in advance cardiac care centers. They are not all born in coordinated care environments. Half of births in many States are Medicaid births as well, so care can often be fragmented. Right now, 

the way the health care system has developed, really to stay at the 

center of your care, you have to be the one that is coordinating it 

yourself, and mobile apps have allowed us to do that. We are able 

to hold in our hand the electronic record now, because of something 

like the Meaningful Use Program of Medicaid providers and maybe 

several different hospitals, several different specialists. And that 

not only is comforting to know that you have access to this information, but it is also very valuable because sometimes when you 

go back into a care situation, it is for a very critical reason, and 

having this information will help you and your provider and your 

care team get to answers much faster. 

Mr. HALL. I thank you for that. I was a father to three boys, 

three sons, and I was amazed because they were so intelligent. 

They could count. If they didn’t count four eyes, they wouldn’t go 

back to sleep. 

Thank you. I yield back my time. 

Mr. PITTS. Chair thanks the gentleman, and now recognizes the 

gentleman from Virginia, Mr. Griffith, 5 minutes for questions. 

Mr. GRIFFITH. Thank you, Mr. Chairman. I appreciate that very 

much. 

I have gotten a sense from some of the questions that somehow 

this is a partisan thing, and I don’t think it is, and so I am taking 

a step back. I am not sure really where that is coming from, but 

I think it is very interesting as a lawyer and I am learning all this 

medical stuff, and I thank you all for educating me. But it seems 

to me that the real question is, and what everybody seems to have 

agreed on is that we as Congress need to make sure there is a 

framework that then you can put the complicated does this fit, does 

that not fit, into that framework. Am I correct in that, Dr. Mitus? 

Dr. MITUS. Absolutely. 

Mr. GRIFFITH. Dr. Smith? 

Dr. SMITH. I might add, if you would let me. I think that we if 

we whisk overprescribing this framework, and I think at some 

point there is a role for not drawing the sharpest of line, but to 

give latitude to the bedside where the patient and physician can 

decide whether technology is appropriate in use, as opposed to trying to draw one line for the broad population. 

Mr. GRIFFITH. And I think we all want to see this technology 

being used. It is great stuff and whatever we can do to encourage 

folks to use it, but I do think there is a difference if—in the case 

of a picture of a mole, if the mobile app is actually running it 

through a computer and telling you it is cancerous or not cancerous, then yes, I want the FDA looking at that. If the mobile app 

is getting that to an expert doctor to take a look at it, I don’t see 

that as being a medical device, and if there is a problem with the 

diagnosis—and I would think that Mr. Waxman would appreciate 

this—there are a slew of trial lawyers who would be more than 

153 

happy to help you figure out what you need to do next if there is 

a misdiagnosis. So I think we go from there. 

I am concerned that the FDA sometimes tends to be slow, and 

if we have got something that doesn’t fit the norm, obviously if it 

is something serious like the app is making the decision on whether or not that mole is cancerous, yes, then I want that top thing 

and I kind of like the framework that you pointed out, Dr. Mitus. 

If we don’t have that kind of a framework and they decide to review everything, wouldn’t you all—and I guess I will ask Dr. Mitus 

and Dr. Smith this question, and Mr. Bialick and others can chime 

in if they wish. But isn’t there a real concern that the slowness of 

the FDA, particularly if you are looking at something that just 

transmits the data, can actually slow down innovation in this area 

where we really want the innovation to go forward? Dr. Smith? 

Dr. SMITH. So you know, as a practicing cardiologist, I would 

often get records to make decisions based on transmission through 

a fax machine, and at that time, it was difficult to tell the difference between a three, a five, and an eight. And so one could 

make wildly different decisions based on that communication transfer, which no one regulates. Now that we make it so crisp and so 

clear and so error-free, now I don’t believe is necessarily the time 

to regulate that particular flow of information. I think the market 

has served the need in this case, and so if it is really just about 

transmission of information, it is difficult to see even though that 

information may be clinically relevant, that that is necessarily 

something that requires FDA oversight. 

Mr. GRIFFITH. It is funny how sometimes people can interpret old 

rules with new technology and get it wrong or get a different answer. In my law practice, if I had a book, I got taxed on it. If it 

was a disc, it didn’t get taxed. If I could subscribe to an online site, 

it didn’t get taxed. But if it was a book, by golly, I had to pay tax 

on that book. 

Let me ask this about the smaller creative entrepreneurs, Mr. 

Bialick. 

Mr. BIALICK. Bialick. 

Mr. GRIFFITH. Bialick, thank you. In your opinion, if the FDA is 

successful in classifying all these medical apps, those particularly 

that I know we are talking about data are essential data’s medical 

devices, do you think that might discourage some of the app makers to go into something that is easier to get their capital back out, 

or a quicker return on their investment? 

Mr. BIALICK. Absolutely. The threshold for a blockbuster app is 

gigantic now. I mean, it is millions of dollars, and so even to get 

the investment now to—let’s say you are going to develop it beyond 

just in your garage and have a large scale launch. The concern that 

you will have the potential for or if it is known that you will have 

additional regulation on top of that cuts out the bottom line, so 

there is an investment side to it, too. 

Mr. GRIFFITH. So they are more likely to try to find the next 

Angry Bird as opposed to finding the next Angry Mole? 

Mr. BIALICK. Well said. 

Mr. GRIFFITH. And last—and I only have a couple of seconds left. 

I am just going to make a statement. I think a lot of us on this 

committee feel that the FDA is not only risk averse, but they are 

154 

at the point of no risk. We don’t want to approve something if there 

is any risk, and obviously every human being is a little bit different 

and whatever you do, there is going to be at least some risk. And 

so I would just encourage the FDA to work with you all and hopefully we will pass that framework that you want and get it done. 

Thank you, sir, and I yield back. 

Mr. PITTS. Chair thanks the gentleman, and now recognizes the 

gentleman from Texas, Mr. Green, for 5 minutes for questions. 

Mr. GREEN. Thank you, Mr. Chairman. I would like to thank our 

witnesses for appearing today. 

As mobile technology has gotten more sophisticated, applications 

relating to health have become more complex, but also hold more 

potential. The possibilities of innovation are tremendous, but there 

is potential risk to health safety as well. Mobile applications such 

as glucose monitors are being sold as a way to monitor critical 

health issues, or other applications having direct effect on health 

should be regulated in a way that ensures their effectiveness and 

trustworthiness. 

Regulation through the FDA comes with challenges. The agency 

is oftentimes far too slow. Obtaining approval can be costly. I worry 

about stifling innovation and bringing in unnecessary levels of regulation onto clever people with limited startup capital, but unlimited potential. However, even big companies have made high profit 

mistakes developing mobile apps. Had the recent mishap with a 

mapping software been a glucose monitor, there could have been 

serious consequences. But we must protect patient and consumer 

safety at all costs, but properly determining what poses as a safety 

risk may prove difficult. 

Dr. Mitus, the Bipartisan Center framework focuses on clinical 

and nonclinical software. It also recognizes the role for FDA oversight for medical device software. Do you agree with that approach 

and that FDA does have a role for the oversight of riskier MMAs? 

Dr. MITUS. Yes, absolutely. 

Mr. GREEN. OK. In what ways can the FDA regulate mobile medical applications as mobile devices without slowing innovation? 

Dr. MITUS. We believe that if a device, again, is defined as something that directly touches a patient or independently acts on a patient, that is a medical device and the software that runs that device would be considered a medical device, and subject to the current regulatory process. I think it is very important to distinguish 

that from the vast bulk of health IT, which is really not best categorized as a medical device. 

Mr. GREEN. OK. Dr. Classen, a lot has been discussed about riskbased framework for regulation. As I read it, there are a lot of similarities between FDA’s and the Bipartisan Policy Center’s approaches. In what ways do the BPC recommendations differ from 

the draft guidance issued by the FDA? 

Dr. CLASSEN. The guidance that we focused on in our report at 

the Institute of Medicine, a lot of the FDA guidance excluded what 

we were focused on there from their oversight on mobile medical 

apps, and we had recommended that a new framework be created 

for oversight of these areas. So we would agree with BPC Center 

approach and framework as a next step, creating more specificity 

around a future framework as we have outlined. 

155 

Mr. GREEN. I do have concerns about the capacity of the FDA to 

properly and efficiently regulate mobile apps. This is a topic that 

deserves more scrutiny by Congress and the FDA. We must find a 

way to ensure that the safety and effectiveness of the applications 

regulate only the application that posed a risk, and do so in a way 

that is efficient and effective. 

Mr. Chairman, members of Congress always doesn’t do things 

that are efficient and effective, but in this case, because it affects 

the health care and how we can deliver and monitor health care 

in the future, it is so important not only for our subcommittee, but 

the full committee and Congress. 

Thank you, Mr. Chairman. I yield back my time. 

Mr. PITTS. Chair thanks the gentleman and now recognizes the 

gentleman from New Jersey, Mr. Lance, for 5 minutes for questions. 

Mr. LANCE. Thank you, Mr. Chairman, and good morning to you 

all. 

I have heard from at least one app developer in my district who 

has been attempting to work with the FDA to approve the medical 

app. This involves a smartphone and corresponding app that helps 

patients with diabetes monitor the diabetes and so they can track 

their glucose levels. It is my understanding that while the procedure is currently under review at the FDA, the approval process is 

slow moving and there are some levels of uncertainty as to how the 

agency can address or regulate the technology. Your testimony this 

morning has involved this type of discussion. Do you believe that 

the experience of companies such as the one with whom I have 

been speaking in my district are common experiences that companies have, and should we be concerned about the FDA as it goes 

forward to regulate mobile apps as medical devices? To whoever 

wishes to respond to the question. 

Dr. SMITH. So I do believe it is about clarity and speed, and I 

think we are in part here today because it was in the middle of 

2011 when draft guidance was issued in this space, and we still 

don’t have the clarity and certainty of even that guidance, which 

by itself, still has elements in it which maintains some vaguery. 

And so, I believe we are suffering the confusion of successive clarification, as opposed to enjoying the speed of appropriate regulatory 

efforts. And so I think it is both slow for the folks who are engaged, 

but perhaps even slower for those who are hesitating to engage and 

are finding other things to do with their time, treasure, and talent. 

And so I think it is fundamentally about clarity and speed, and at 

times, even willing to accept the imperfect now as opposed to waiting interminably for some other perfected notion of regulation. 

Mr. LANCE. Of course. 

Mr. BIALICK. I would like also just to say, I won’t comment on 

the frequency with which that is a common occurrence, but I would 

like to say that that viewpoint and the experience of a developer 

like that is critical to this process. We talk about large apps, we 

talked about the apps that are being developed in a garage or a 

basement or an attic. We want to also make sure that those that 

are going to be engaging in this process and those that have made 

this market so dynamic, their viewpoint and their experience is 

brought into the process as well. 

156 

Mr. LANCE. It is clear to me that this would be helpful to those 

who have the condition of diabetes, and this is a well-respected 

group and wants to move forward in a medically responsible way. 

What would you suggest that we as the legislative branch do to 

help the FDA move through this situation to benefit the American 

people, particularly as it relates to such health concerns as diabetes? 

Dr. MITUS. We would like to reiterate what you have just articulated so well. There is a risk, barriers to entry and to this important space, the delay of important advances into health care, and 

really we support a risk-based approach where we continue to manage devices as they are today, and then develop other mechanisms 

for the important oversight of health IT that is not a device. 

Mr. LANCE. Yes, Dr. Smith? 

Dr. SMITH. I would like to draw attention to the impact that the 

delay between draft guidance and formal, permanent guidance provides. So it goes well beyond the current issue. The next draft guidance offered, if there is a doubt that that will become final, you will 

have no movement based on the draft. No companies will engage 

based on those recommendations, for fear that that process will be 

again derailed. And so imperfect as it may be, I think there is a 

value proposition that says fulfill that draft promise, or else we 

risk the notion that the regulatory cloud becomes even larger. And 

so I think there is a calculus to be performed here, but one that 

has implications well beyond the current discussion. 

Mr. LANCE. Thank you. Let me say, I do not view this as a partisan issue, and I want to work in a bipartisan capacity with colleagues on the other side of the aisle, as well as with those on this 

side of the aisle which I am involved, because we want to do this 

in a responsible way, making sure that the American people can 

have access to these marvelous new portions of improving the 

health of the Nation. 

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

Mr. PITTS. Chair thanks the gentleman and now recognizes the 

gentleman from Maryland, Mr. Sarbanes, for 5 minutes for questions. 

Mr. SARBANES. Thank you, Mr. Chairman. This is a fascinating 

hearing. 

When we were doing the health care reform effort here, which 

resulted in the Affordable Care Act, one of the things that I was 

most excited about was this turn in the direction of prevention with 

our health care system and trying to come up with a system that 

is a health care system, rather than a sick care system, which in 

many ways is what we had until now. But the promise of it is that 

patients can become full partners in their care, and at a time when 

we worry about whether there is going to be enough caregivers to 

provide the services out there, if you begin to identify the patient 

themselves as a potential caregiver, you get a little less anxious. 

Now, you have to approach that in a sensible way, but if we are 

focused on so the acute care side of things, I can’t help my surgeon 

perform surgery on me, but I can certainly help my primary care 

physician make me more sensible about prevention. So I really become a partner in that, and this technology holds that real promise. 

157 

There was—Dr. Francis Collins, who is the director of NIH, recently highlighted the results of a mobile health clinical trial in his 

personal blog, and this was a trial conducted over a year by University of Maryland School of Medicine, which utilized a diabetes 

mobile health technology of a company that I am very familiar with 

called WellDoc, which is based in Baltimore. And they showed that 

these patients were able to demonstrate a reduction in terms of the 

percentage result on their blood sugar test that they would take on 

a regular basis, and the same system was studied in a demonstration project of Medicaid patients, where patients used this diabetes 

self-management system, with the result of reducing the number of 

diabetes-related hospital admissions and emergency room visits 

among that population that was using it by approximately 57 percent, which is really incredible. And a lot of times people do end 

up in the hospital because they have missed some basic precaution 

they need to be taking in their own self-management, so it just 

shows how important these opportunities to use technology are in 

terms of self-management by patients, and you have all spoken to 

that. 

My question, and I offer it to anyone here on the panel, is as we 

continue this effort to reduce our health care costs, and there is 

real potential using this technology to do that, can you point to instances where federal programs are beginning to adopt these validated technologies across the spectrum of government health care? 

And you can—if you want to point to Medicaid and Medicare, 

please do, to the Federal Employees’ Health Benefits Program, 

TRICARE, Veterans’ Affairs, what have you, because obviously we 

are very interested in that, given the cost and scope of those programs. 

Ms. BECHTEL. So I will start, and I say that I think it is a terrific 

question, and my testimony really focused on the Meaningful Use 

Program in Medicare and Medicaid, because of the work that it is 

doing to make patients full partners in their health. Giving patients access to electronic tools is really making them members of 

the care team now. We are moving from a point where we used to 

do things to patients and for patients to now doing things with patients, and that is essential to lowering costs and making care better for them. And the online tools are really facilitating important 

things like shared decision making, population health outreach so 

that we can get reminders about being overdue for a mammography screening or immunization or—whether it is pneumonia or 

flu shot or something like that. And it is also facilitating the provision of education resources for patients that are very specific to 

their needs. So we are moving to a health care system that is much 

more customized and personalized and engaging for patients and 

families, and so that is why I think that it is essential as we move 

forward in the Meaningful Use Program to really keep up the pace. 

In the next phase, we are going to give patients online access that 

they can download their health information and transmit it to 

other care providers who need it. We are going to give them the 

ability to securely send an e-mail to their doctor. I mean, there are 

some really important advancements that are coming down the 

pike if we just keep our foot on the gas pedal. 

158 

Mr. SARBANES. Mr. Chairman, would you indulge one more response from Dr. Smith? 

Mr. PITTS. Go ahead. 

Dr. SMITH. So I point to the VA here. Adam Darkins runs the 

VA telehealth program. In 2012, I think there were 1.5 million telehealth visits. The net impact of that at 150 VA medical centers is 

to drop emergency room visits by 40 percent, hospital admissions 

by 63 percent. Patients experienced a 60 percent reduction in hospital days. Nursing home admissions dropped by 63 percent, and 

patients reported a 95 percent satisfaction rate with their care. 

And that is the largest functioning telehealth program that we 

have in the country, and it is run by the Veterans’ Administration. 

I think it is one of the best kept secrets of excellence inside the 

Veterans’ Administration, and it speak to the potent opportunity 

that this has when we align the incentives system so that this 

technology is fully realized. 

Mr. SARBANES. Thank you. Those are powerful statistics. I yield 

back. 

Mr. PITTS. Chair thanks the gentleman and now recognizes the 

gentlelady from North Carolina, Mrs. Ellmers, for 5 minutes for 

questions. 

Mrs. ELLMERS. Thank you, Mr. Chairman, and thank you to all 

of our panelists today for this very important subcommittee hearing. 

First I would like to just say that across the board, health IT is 

so important. We have got to do everything we can to make it move 

forward quickly for our patients. As you all have pointed out, the 

very helpful information that we are gaining from it and how this 

truly will improve upon health care in this country, with all the 

hurdles that it has faced. However, having said that, I think it is 

incumbent upon myself to point out that it isn’t quite the nirvana 

that has been discussed here. For instance, when we are talking 

about the Meaningful Use, as Ms. Bechtel, you had cited some of 

the statistics, the number of physicians, the number of hospitals, 

however, we do have to remember that this is a mandate that was 

put forward and physicians are participating in it because if they 

do not, they will receive a Medicare reimbursement cut. So it is not 

only very beneficial and very important; however, it is very costly 

and at a time in this economy when you see what we are faced 

with, physicians being small business owners themselves, hospitals 

having difficulty functioning, physicians—tens of thousands of dollars that they are having to incur to put this into place, hospitals, 

millions of dollars. It is a challenge. And again, the importance 

being duly noted, however, very difficult for many physicians to be 

incurring this cost. 

With that, I do have a question. Ms. Bechtel, you had mentioned 

that this situation—that we are moving forward and it is very important, and that there are many of these physicians, but you do 

acknowledge the fact that it is a mandate? 

Ms. BECHTEL. Absolutely, and I think it points to the problem 

that we have in the larger system, which is a complete lack of payment, that really drives quality and the development—— 

Mrs. ELLMERS. Absolutely. 

159 

Ms. BECHTEL [continuing]. Of functionality, as you well know, 

and I know you are a big supporter of health IT, when we have 

fee-for-service, of course we are going to see the proliferation of billing systems, and we have no problems in interoperability or adoption rates of billing systems that are designed to really focus on 

services. 

Mrs. ELLMERS. And two, this is my next question. We had also 

discussed the fact—and I think you had mentioned that at some 

point in the future, patients will be able to download their own information. Now, there again, I see a big problem and this feeds into 

the reason that we are having this subcommittee hearing, which is 

the future, where are we going to go, how is FDA regulation going 

to affect these things, how is medical device tax going to keep technology from innovating and moving forward? 

One of the issues that I continuously hear about is the fact that 

communication or software is different, the different systems that 

physicians, hospitals, and others use, so there really is a communication problem right now. What timeline do you—number one, do 

you acknowledge that, and two, what timeline do you see that happening for patients to be able to download information on their own 

so that they can be partners in this? 

Ms. BECHTEL. So you can do this if you are a veteran through 

the VA right now, or through the Medicare program. The ability to 

do it through the Meaningful Use Program, which will be from the 

EHRs, is going to start in October of this year for hospitals, and 

in January for physicians. 

Mrs. ELLMERS. But do you—have you also heard that there is a 

communication problem between different facilities, physician offices and hospitals, different health care—— 

Ms. BECHTEL. Yes. It is one of the most common complaints we 

hear from consumers is the lack of coordination and the lack of 

communication. They say over and over again, I just want my doctors to talk to each other. The problem is they are not paid to talk 

to each other, so Meaningful Use has done a couple of things. One 

is there is an open standard now called the Direct Protocol, which 

is essentially like secured g-mail. Physicians and soon patients can 

actually use it right now to talk to each other, so you can have a 

hospital send a care summary to a primary care clinician—— 

Mrs. ELLMERS. OK. Can I just—I need—I only have 30 seconds 

left here, and I do have a question for Dr. Mitus. Now, you had 

mentioned that doctors are not paid to talk to each other. How do 

you describe that? 

Ms. BECHTEL. Because they are not paid for care coordination, 

they are paid on volume for services and procedures. So my doctor 

doesn’t get reimbursed for picking up the phone and calling my cardiologist and coordinating—— 

Mrs. ELLMERS. So you are basing that on payment? 

Ms. BECHTEL. Under fee-for-service. 

Mrs. ELLMERS. OK, fee-for-service, oK. 

Dr. Mitus, and again, I apologize because this is such an important issue for me. The Commonwealth Alliance that you put together, what do you see Meaningful Use not doing that you feel is 

an issue that needs to be addressed? In other words, where are 

your areas of concern and the Commonwealth Alliance’s concern? 

160 

Dr. MITUS. May I take a few moments to answer? 

Mr. PITTS. You may proceed. 

Mrs. ELLMERS. Thank you. 

Dr. MITUS. Thank you for raising an issue that we are very 

proud of, that we announced with an intention to launch, led by 

McKesson, Athena Health, Allscripts, Cerna, and Greenway. We 

are really trying to create to solve the very difficult problem of disparate health systems and the ability to communicate across those 

health systems. It is one thing to gather data from an electronic 

medical record within an individual physician’s office, but that ability to aggregate information from all the sites of care is a tremendous problem. We are attempting to solve that and create interoperability and seamless communication by setting standards and 

creating an infrastructure to support those important processes. 

Mrs. ELLMERS. Is there a government HHS or any other agency 

that is hampering this availability that you are aware of? 

Dr. MITUS. Not that I am aware of. 

Mrs. ELLMERS. OK. Thank you so much, and again, thank you, 

Mr. Chairman, for indulging me for a few moments. 

Mr. PITTS. Chair thanks the gentlelady and now recognizes the 

gentleman from Georgia, Dr. Gingrey, for 5 minutes for questions. 

Mr. GINGREY. Mr. Chairman, thank you very much. 

This is really for all of the panelists. Some have suggested that 

the mobile apps may be a game changer for health care delivery 

and consumer engagement. Do you agree with that statement, or 

do you believe they have already changed? Why don’t we start at 

the end and—— 

Dr. SMITH. It would be sad if where we are is where we are 

going, and so I have to believe that we are looking at the front 

end—on the cusp of a transformation in health care where engaged 

consumers work with a coordinated and integrated health care system, and so we can realize the important benefits of having ambient health care as opposed to having the model of health care delivery that we have been living with since my grandparents. 

Mr. GINGREY. Sure, thank you. 

Mr. BIALICK. I 100 percent agree with that, absolutely agree with 

that. 

Dr. MITUS. I support the comments of my colleagues. 

Dr. CLASSEN. And I would agree. 

Mr. GINGREY. All right. Excuse me, I didn’t realize my phone was 

alive. I apologize for that, panelists. 

Dr. Smith, who makes mobile apps? It is sophisticated, big developers or are we talking about the little developer working out of 

the garage, the entrepreneur types, or is it both engaged in this activity? 

Dr. SMITH. So over the last 3 years, I have probably met with 

1,000 companies that are interested in this space, all small, all 

largely unaware or incompletely aware of the regulatory framework 

that they are kind of naively entering, and find a bit of frustration 

as they realize that there is this other burden that they are not yet 

aware of. It is not enough to solve the problem; one must then engage a system with its own set of rules. And so it is often a fresh 

graduate out of graduate school, or even an undergrad who identiVerDate Nov 24 2008 13:42 Sep 13, 2013 Jkt 037690 PO 00000 Frm 00166 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-21 CHRIS
161 

fied a problem in his family, the health care that they see, and are 

trying to figure out a way to solve it. 

Mr. GINGREY. The next question is for Mr. Bialick. Today, there 

are roughly 97,000—I can’t believe that, but this is a statistic that 

I have. Today, there are roughly 97,000 medical apps in the Apple 

app store, 97,000. These apps have generated more than three million free downloads. If the FDA regulates medical apps as medical 

devices and these products have to go through regulatory review at 

the agency and then they become subject to the 2.3 percent medical 

device tax, how likely do you believe it is that these apps will remain free to the public? 

Mr. BIALICK. I would just say that any additional costs added to 

the development process is going to change the marketing approach 

for them. This is a very capitalist market that we have created in 

health care apps. I would say that if you are going to increase the 

startup cost, if you are going to recoup that cost within a reasonable amount of time, you are likely going to have to change how 

money is coming in, and so that is either going to be to stop offering them for free, or require that end users pay for additional 

functionality within the app itself. 

Mr. GINGREY. Well sure, exactly, and I will stay with you, Mr. 

Bialick. The death toll for chronic conditions is a staggering number. More than 10,000 people die every day because of chronic conditions. Not only is the human toll large, but of course, the economics behind it are driving up health care costs, they are harming our 

household and national finances, and as these costs for health care 

go up, more money is diverted from other programs. It is diverted 

from job creation, indeed, from consumers’ pockets. How can health 

information technologies such as medical apps or electronic health 

records, if not classified by the FDA as medical devices, how can 

they address these problems and how do we accelerate their use? 

Mr. BIALICK. So to address the—let’s look at a really high cost 

problem specifically to get to your question, which would be something like dually eligible beneficiaries between Medicare and Medicaid programs. Even if you target a specific issue like using these 

mobile apps to provide very high touch care, so we are not talking 

about managed care, but rather, we are talking about a direct way 

for the patient to be reminded for something, like imagine, taking 

their medication, some of these issues that could avoid the number 

of costly returns to the hospital. That is a very direct and tangible 

way that people can interact with their health care. That is what 

should be accelerated. 

Mr. GINGREY. Well, and that is the point I wanted to make to 

the witnesses and to my colleagues on the subcommittee. These devices, these medical apps, they don’t draw blood. They don’t take 

a biopsy. They are not invasive. They are just giving information 

to people in a timely fashion, and if permitted, to members of their 

family so that they know what is going on with mom or dad who 

5,000 miles away and maybe very elderly, or maybe even in a nursing home. I mean, this is a hugely important subject and I commend the chairman for assembling this panel of witnesses and discussing this subject. 

So Mr. Chairman, I thank you for letting me go over a little bit, 

but I appreciate it and I yield back. 

162 

Mr. PITTS. Chair thanks the gentleman, and now recognizes the 

gentleman from Florida, Mr. Bilirakis, for 5 minutes for questions. 

Mr. BILIRAKIS. Thank you, Mr. Chairman. I appreciate it very 

much. Thank you to the panel for their testimony. I was over in 

VA. I apologize, but that is very important as well. 

I want to—question to Mr. Smith. You mentioned in your testimony the potential cost savings benefits of telehealth. Do you believe it is feasible to expand the use of telehealth to Medicare to 

effectively lower its costs? 

Dr. SMITH. It is a simple word, absolutely. I could go on, but we 

have seen the impact of telehealth and telemedicine—New England, the Health Care Institute, the VA program, there is a rich 

history of information, some of which I provided in my written testimony, about the beneficial impacts not only on outcome but also 

on costs. And so it seems obvious that we can extend that to patients struggling with chronic disease, independent of how their 

health care bills are paid. 

Mr. BILIRAKIS. Very good, thank you. 

Follow up again to Mr. Smith. With doctors showing an increase 

of reluctance to accept new Medicare patients, for obvious reasons, 

do you believe that allowing doctors to use telehealth will enable 

them to expand their reach in not only treating existing patients, 

but also increase access by enabling them to treat new beneficiaries? If you could elaborate a little bit. 

Dr. SMITH. Sure. I think the technology obviously enables that 

notion of care at a distance in ways that are much more efficient 

than, say, in addition to the costs associated with travel, say, many 

of the costs associated with—in unnecessary or untimely ER visits 

or doctor’s office visits. But I think it is not enough to have the 

technology enabled, we also have to have payment mechanisms 

that provide appropriate incentives for use. And so I was talking 

to a colleague who is a dermatologist and I asked about this—the 

world of teledermatology. And he says, it is never going to take off 

because I don’t get paid for it. I think that is an unfortunate, but 

rational, statement. 

Mr. BILIRAKIS. Very good. Anyone else on the panel wish to comment? 

Mr. BIALICK. I would like to just specifically on that point about 

taking on more Medicare providers. I think that when we talk 

about telemedicine, we think about it in a traditionally rural setting, so it is the idea of someone that lives in the country that 

doesn’t have access to advanced care facility that is using telemedicine to connect to that. But especially from what we have learned 

from the VA around telestroke interventions as well as a number 

of other occupational therapy style interventions that you are able 

to do via telemedicine, this is absolutely something that can be leveraged to not only increase—improve outcomes, but save money in 

the urban setting as well. 

So we shouldn’t be thinking about this as a purely rural situation, but this is also something that can be done in an urban situation as well, and still much like we are talking about with the idea 

of regulation of apps, there are major regulatory barriers in place 

that are limiting the amount that Medicare providers are able to 

do that. 

163 

Mr. BILIRAKIS. Thank you. Anyone else? 

Thank you very much. I yield back, Mr. Chairman. I appreciate 

it. 

Mr. PITTS. Chair thanks the gentleman. That concludes the questioning. 

At this time, I would like unanimous consent to place two documents into the record. The first is a letter from Kevin McCarthy, 

the second is a statement from the Bipartisan Policy Center. I 

think you have seen these. So without objection, so ordered. 

[The information appears at the conclusion of the hearing.] 

Mr. PITTS. This has been a very interesting hearing, very important issue, very informative. We would like to thank all the witnesses for taking time and presenting testimony and answering all 

the questions. Members may have follow-up questions. I will remind members they have 10 business days to submit questions for 

the record, and I ask the witnesses to respond to the questions 

promptly. 

With that—and members should submit their questions by the 

close of business on Wednesday, April 3. With that, thank you very 

much. Without objection, the subcommittee is adjourned. 

[Whereupon, at 12:00 p.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

PREPARED STATEMENT OF HON. PHIL GINGREY

Mr. Chairman, Thank you for calling this hearing today, and I commend the committee looking at the benefits that health information technologies can provide to 

the practice of medicine. The possibility that these emerging technologies may encourage higher patient engagement and ultimately better health outcome is impossible to ignore. 

An impediment to innovation continues to be the uncertainty regarding the regulation of these technologies. We must seek a balance between patient safety and innovation. An overly restrictive regulatory process will stifle innovation and ultimately lead to erosion in the quality of care that a patient may receive. We need 

to work together to develop a framework that minimizes risk to a patient, but limits 

the regulatory hurdles so that future innovation will continue to change health care 

delivery and a patient’s access to their health information. 

Mr. Chairman, I look forward to working with the Committee to develop this 

framework. I still believe in the amazing potential that health information technologies will have on the practice of medicine, and I will continue to work to allow 

the market to develop breakthroughs to the benefit of patients. 

Thank you and I yield back. 

164 


80806.044

Mal'ch20,2013 

Dear Chairman Upton and Chairman Phts, 

I would like to thank you for holding this week's series of hearings on He,llth 

Information Technology (IT) and mobile medical applications. As the hub for this industry, with 

the largest number of digital health investment deals in 2012, it is a topic of utmost economic 

importance to Califomia. More important is the promise it holds of improving the hcalth of all 

Americans. 

lVfobile electronic devices have already revolutionized the way we receive our ncws and 

communicate with one another. Industries such as banking and retail services have been 

transJi,lrmed, with billions of secure transactions occurring seamlessly in cyberspace <::ach day. 

Our globalkadership in wireless deviccs and nctworks is unrivaled, and it is essential 10 put 

America's innovation engine to work for patients. This is critical to reining in the runaway costs 

of medicine by creating a modem, efficient, pcrsonalized, and patient-centered health can; 

system. 

My stalc stands ready with the bright minds and great ideas neceSSalY to cmpo\vcr and 

inform patients using the devices they carry in their pocket My district covers a vasi and ortcn 

remote landscapc. The ability of patients to use theil' wireless device to consult their physician or 

update them on their latest blood pressure readings would be transformative. It would eliminate 

the costly and sometimes life-threatening barriers of time and distance that separate patients and 

healtheare in tbe Central Valley. 

In 2012, there was $1.4 billion invested into the digital health sector, a 46 percent 

increase over :W 11. i Tbe market for mHealtb app services is now in the commercialization phase 

and is expected to reach $26 billion globally by 20 17.ii The growth potential for this industry is 

imprcssil'c; unfortunately, there is increasing concern from both innovators and those who invest 

in them, that it will be hindered by undue Food and Drug Administration (FDA) involvement. 

I commcnd the Energy and Commerce Committee tor holding hearings on this important 

subject. Given the significance of these technologies to patients, we must take the appropriate 

steps to supporll11cdical innovation and enSurc (hat the rcgulatOlY burdens of the FDA and 

medical device tax of Obamacare do not hinder their promise. 
165 


80806.045

I look forward to continuing to work with you on protecting and cultivating innovation. 

This priority is of utmost importance to the economic and physical well-being of my constituents 

and all Americans. 

; Rock lkalth, 2012 DigilClIl/ealth Funding Report, January 3, 2013, available at 

lllll?;;~\'\\·\\'. ,I id",llare .netiRoekH ea 11 11.-'20 12-ve~r-el1d· fun.d ing·r~l1. 

"Jahns, Ralf~GQI'don, The 

March 3, 2013, available 

bjJliill~:.Ql:';?,lU2: . 

services will reach 826 hff!iol1 by 20J 7, Rescardf~Olljdanccl 
166 


80806.046

Written Statement of 

The Bipartisan Policy Center 

For the Energy and Commerce Subcommittee on Health 

U.S. House of Representatives 

March 20, 2013 

The Bipartisan Policy Center (BPC) commends the Energy and Commerce Subcommittee on 

Health's exploration of the unique role that health information technologies have played in 

advancing the health and well-being of patients nationwide, as well as the public dialogue 

which it has initiated on the regulatory framework that should be applied to such technologies. 

Today, health care costs constitute 18 percent of our nation's gross domestic product and the 

quality of care remains uneven. Rapidly emerging delivery system and payment models 

designed to improve quality, reduce costs, and improve the patient's experience of care require 

a strong information technology (IT) foundation to be successful. Several studies have shown 

that health IT, if effectively designed and implemented, has a positive impact on patient 

safety, the efficiency and effectiveness of care, and patient and provider satisfaction. 1 

Building upon numerous legislative proposals with bipartisan support over the last decade, the 

Health Information Technology and Economic and Clinical Health (HITECH) Act of 2009 brought 

about new authorities, standards, and investments in health IT. As a result of federal, state, 

and private-sector action, the number of clinicians, hospitals, and other providers across the 

United States who have adopted health IT to improve the quality, safety, and efficiency of care 

has significantly increased. 

The widespread adoption of health IT largely stems from recognition of the important role that 

it plays in improving health care quality and safety. Policies are now being developed by the 

Department of Health and Human Services (HHS) to use health IT to make health care safer 

and continuously improve the safety of health IT. 

Through a five-month, collaborative effort drawing upon the expertise and experiences of more 

than 100 leaders representing clinicians, consumers, health plans, hospitals, patient safety 

organizations, academic and research institutions, and software and technology companies, as 

well as experts in patient safety and health IT, BPC developed a set of principles and 

recommendations for assuring patient safety in health IT. The BPC report containing these 

principles and recommendations, An Oversight Framework for Assuring Patient Safety in Health 

Information Technology, was released to the public on February 13, 2013. 

Through this process, BPC identified several factors associated with health IT that led to the 

development of a set of principles that should be applied to any oversight framework. 

Bipartlsan Policy Center 

Written Statement for Energy and Commerce Subcommittee on Health 

Page 1 
167 


80806.047

1. Any framework for safety should recognize and support the important role that 

health IT plays in improving the quality, safety, and cost-effectiveness of care, as 

well as the patient's experience of care. 

Research shows that health IT has a positive impact on the quality, safety, and costeffectiveness of health care.' While the widespread adoption of health IT largely stems from 

recognition of the important role that it plays in improving health care quality and safety, 

there are also instances in which it can create harm if not effectively developed, 

implemented, or used. 

Because of the significant role that health IT plays in improving the quality, safety, and 

cost-effectiveness of care, as well as the patient's experience of care, any framework for 

safety should both recognize and support innovation in and adoption of health IT. 

2. Assuring patient safety, along with enabling positive patient outcomes, is a 

shared responsibility that must involve the entire health care system. 

Assuring patient safety in health IT is a shared responsibility among the many stakeholders 

within the health care ecosystem. As noted in the recent 10M report, safety is part of a 

larger sociotechnical system that takes into account not just the software, but also how it is 

used.' This larger system includes technology, people, processes, organizations, and the 

external environment.' 

The level of safety in health IT depends on how the technology is designed, customized, 

implemented, used, maintained, and incorporated into clinical workflows. The quality of 

data, the interoperability of IT systems, and the appropriateness of clinical interventions 

also have an impact on health IT safety. Additionally, education, training, and proficiency of 

users can playa critical role. Finally, health IT supports-but does not replace-the 

judgment of clinicians. 

Any oversight framework for safety in health IT should have strong support from and 

involvement of all stakeholders, including patients. 

3. Any framework for patient safety in health IT should be risk-based, flexible, and 

should not stifle innovation. 

The scale and scope of oversight requirements intended to ensure patient safety in health 

IT should be correlated to the potential risk of harm to patients. 

Health care is a continually evolving ecosystem that is now undergoing conSiderable 

change. Health IT plays a foundational role for rapidly emerging new models of delivery 

and payment that promise to improve the quality, safety, and cost-effectiveness of care, 

such as accountable care arrangements and the patient-centered medical home. 

Health IT must evolve to support rapidly emerging changes in the health care system and 

must continually be upgraded and/or customized to address the ever-changing needs of 

those who deliver, manage, pay for, and receive care. Innovation is needed to continually 

drive improvements in the cost, quality, and patient experience of care. 

Bipartisan POlicy Center 

Written Statement for Energy and Commerce Subcommittee on Health 

Page 2 
168 


80806.048

Any framework for safety in health IT must be flexible and promote-not stifle-the 

innovation needed to drive further improvements in health and health care. Current 

regulatory frameworks that are oriented toward turnkey devices that change infrequently 

and are often not customized based on the needs of the user, do not align well with the 

current and anticipated nature of health IT. 

4. Existing safety and quality-related processes, systems, and standards should be 

leveraged for patient safety in health IT. 

Policies, processes, and systems associated with assuring safety in health IT should be 

aligned with and integrated into well-established patient safety and quality programs, 

including those that involve accreditation, certification, and reporting. 

Quality management and safety principles, processes, and standards, which are wellestablished and common to other industries, should also be leveraged for assuring patient 

safety in health IT. 

Health IT is an essential component of a comprehensive approach to improving patient 

outcomes and assuring the quality, safety, and efficiency of health care. Any oversight 

framework for health IT should align with and leverage existing processes, systems, and 

standards in health care, and should discourage or prevent duplicative or inconsistent 

requirements. 

S. Reporting of patient safety events related to health IT is essential; a non-punitive 

environment should be established to encourage reporting, learning, and 

improvement. 

Any framework for patient safety in health IT should be data-driven. It should support and 

promote reporting, sharing, and analysis of patient safety events in a non-punitive 

environment that maintains confidentiality and enables learning and improvement. 

Reporting of patient safety events by users, developers, implementers, and patients is 

essential to both gaining an understanding of the nature and magnitude of health ITrelated safety events and developing and implementing strategies to address risks. 

Aggregation and analysis of events and timely feedback to developers, implementers, and 

users are also crUCial, so that necessary changes can be made to address identified issues 

and to mitigate future risk. 

Existing reporting processes and bodies, such as those created by the Patient Safety and 

Quality Improvement Act, should be leveraged. Reporting efforts should be coordinated. 

They should take into account existing work flows, and the burden of reporting should be 

minimized. The use of consistent formats for reporting should be encouraged so that data 

can be easily aggregated and analyzed to support learning and improvement. 

Reporting policies should encourage reporting for learning and improvement. As noted in 

the recent 10M report, "in other countries and industries, reporting systems differ with 

respect to their deSign, but the majority employs reporting that is voluntary, confidential 

Bipartisan Policy Center 

Written Statement for Energy and Commerce Subcommittee on Health 

Page 3 
169 


80806.049

and non-punitive.'" Lessons learned from such other approaches should be integrated into 

any oversight framework for health IT. 

In summary, assuring patient safety in health IT is best accomplished through an oversight 

framework that is risk-based and reflects shared responsibility, promotes innovation, is flexible 

enough to accommodate a rapidly changing health care system, supports learning and 

improvement, and leverages existing safety and quality-related processes, systems, and 

standards. 

Further, any oversight should contain the following key components: 

1. Agreement on and adherence to recognized standards and guidelines for assuring patient 

safety in the development, implementation, and use of health IT. 

2. Support for the implementation of standards and guidelines as well as development and 

dissemination of best practices through education, training, and technical assistance. 

3. Participation in patient safety activities, including reporting, analysis, and response, by 

those who develop, implement, and use clinical software, while leveraging patient safety 

organizations. 

4. Creation of a learning environment through the aggregation and analysis of data to identify 

and monitor trends, mitigate future risk, and facilitate learning and improvement. 

As the Subcommittee engages in public dialogue regarding a regulatory framework for health 

IT, we urge you to consider and draw upon the collaborative report released by the Bipartisan 

Policy Center in February 2013. 

About the Bipartisan Policy Center 

Founded in 2007 by former Senate Majority Leaders Howard Baker, Tom Daschle, Bob Dole 

and George Mitchell, the Bipartisan Policy Center (BPC) is a non-profit organization that drives 

principled solutions through rigorous analysis, reasoned negotiation and respectful dialogue. 

With projects in multiple issue areas, BPC combines politically balanced policymaking with 

strong, proactive advocacy and outreach. www.bipartisanpolicy.org 

1 Buntin M.S., Burke M., Hoaglin M'I and Blumenthal D. (2011). The Benefits of Health Information Technology: A 

Review of the Recent Literature Shows Predominantly Positive Results. Health Affairs, 30(3); 464-471. 

, Ibid. 

3 Institute of Medicine. (2012). Health IT and Patient Safety; Building Safer Systems for Better Care. Washington, 

D.C.: The National Academies Press. 

'Ibid. 

'Ibid. 

Bipartisan Policy Center 

Written Statement for Energy and Commerce Subcommittee on Health 

Page 4 
170 


80806.131

Response to Questions for the Record 

Joseph M. Smith, MD, PhD 

Chief Medical and Science Officer, West Health Institute 

Before the 

Subcommittee on Health, Committee on Energy and Commerce, 

U.S. House of Representatives 

Hearing on: 

"Health Information Technologies: How Innovation Benefits Patients" 

March 20, 2013 

The Honorable Michael C. Burgess 

1. Mr. Smith, you mention the term clinical decision support. Is this something where there already 

are FDA regulations or just an area where FDA is contemplating a new regulatory regime? 

Clinical decision support (CDS) is a logical framework for guiding clinical decisions and is most often 

embodied as a type of healthcare-related software. FDA oversight of such software spans decades 

and major FDA milestones related to software include draft software policy (1989 and subsequent 

withdrawal in 2005), pre-market software guidance (1991), off-the-shelf software guidance (1999), 

general principles of software validation (2002), cybersecurity software guidance (2005), medical 

device data system rule (2011) and mobile medical applications draft guidance (2011). 

FDA regulates some kinds of clinical decision support today; however, the exact parameters of what 

CDS is regulated are unclear. As a result, innovators, investors, and developers lack the certainty and 

predictability of whether their products will be regulated and, if so, what regulatory requirements 

apply. In September 2011, FDA offered a preliminary definition of CDS as software that converts 

information into patient-specific actionable results by any means including algorithms, formulae, 

database look-up, or comparisons or rules and associations. This definition is broad and seems to 

include a Wide-range of CDS products that involve varying degrees of risk to patient safety. BMI 

calculators, for example, may meet this CDS definition but do not involve the same risk as radiation 

dose calculators. FDA has indicated that factors to consider for CDS regulatory oversight include the 

level of impact on subject health condition or disease, degree of acceptance in clinical practice and 

the relative transparency and documentation of internal algorithms used to provide decision 

support, and the ease with which erroneous output can be identified. 

As the agency aims to clarify uncertainties surrounding CDS, we believe the approach should be to 

focus on high-risk products .. This is in keeping with the agency's proposed approach for mobile 

medical applications. The mechanism to share FDA's thinking on CDS would be issuance of draft 

gUidance. We encourage FDA to adopt a regulatory framework that is tailored to risks and clearly 

delineates areas of regulation, enforcement discretion and no regulation. It is our hope that the 
171 


80806.132

recommendations of the external stakeholder working group convened under Section 618 of the 

Food and Drug Administration Safety and Innovation Act (FDASIA) adequately address CDS within its 

proposals for an appropriate, risk-based regulatory framework pertaining to health information 

technology 

Is medication management software considered clinical decision support? 

It depends. Medication management software is an example of why it is important to specifically 

define what constitutes CDS and clarify what will be regulated, not regulated or subject to 

enforcement discretion based upon risk to the patient. Some medication management software 

may help automate workflow. Others may include recommendations for medications that are 

widely accepted, with medical references or sources readily available in the software. Still others 

may recommend dosages for treatment of serious conditions that are based on complex 

calculations that are not transparent to the user. In each of these scenarios, the risk to the patient is 

different and warrants different regulatory treatment. 

a. What about software created by a hospital to follow the care protocols of patients. Would those 

be considered decision support? 

As with medication management software, specific functionality determines whether it would be 

deemed CDS. Functionality limited to documenting and monitoring compliance would not likely be 

construed as CDS, whereas functionality intended to generate new diagnoses and treatment 

recommendations would be considered CDS. Clarification of what constitutes CDS, and its 

commensurate regulatory framework, would help alleviate uncertainty. As described above, a 

factor to consider in determining appropriate oversight is whether the decision-making process is 

sufficiently transparent to allow the clinician-user to make an informed decision. 

b. How about software that might help health information exchanges collect information for a 

patient, is that something FDA is saying it would regulate? 

No. I am not aware of any attempt or plan by FDA to regulate aspects of health information 

exchanges. 

c. Does FDA have expertise of information system types of software? 

FDA's long history of software expertise pertains more to medical devices than information systems. 

Although the agency has been regulating software and various medical device technologies for over 

20 years, the current pace of innovation and increasing sophistication of products is creating new 

challenges that will require a collaborative approach among government agencies (FDA, FCC and 

ONe), advisory groups, and other experts to ensure we take full advantage of the opportunities 

presented by health information technology. For example, ONC, which supports adoption of health 

IT and promotion of nationwide health information exchange, has deep expertise in information 

systems software. Through the Section 618 process, we believe the agencies will have the 
172 


80806.133

opportunity to further their collaboration and leverage each other's expertise. However, it is 

important to note that this collective effort with the necessary expertise must share the goal of 

developing a regulatory framework that eliminates duplication, delay and uncertainty. Clear, 

predictable, and transparent regulatory guidance - that is adaptable to the rapid pace of innovationis required to ensure health information systems flourish. 

2. Mr. Smith, you mention burdens posed by HIPAA regulations. Can you describe a few examples? 

Confidence in the security and privacy of one's personal information is a cornerstone of health 

information exchange and true healthcare transformation. The final omnibus HIPAA rule announced 

January 17, 2013 enhances patient privacy protections, provides individuals new rights to their 

health information, strengthens the government's ability to enforce the law and increases penalties 

for noncompliance. 

Unfortunately, these regulations are a complex set of rules that create administrative and 

compliance burdens that often lead to misinterpretation of the rules. This ultimately frustrates 

efforts to coordinate care and share information. 

For example, the audit trail for protected health information (PHI) is one challenge. Insufficient data 

capture from traditional log files and systems leaves gaps, particularly around the explanation of 

why data was accessed. This gap may leave companies, especially smaller businesses, with greater 

exposure to steep noncompliance penalties. Some providers have "over-protected" patient 

information out of fear of fines to which they would be subjected if they shared information with an 

unauthorized person or entity. This has led to frustration for individuals trying to access their own 

information or that of loved ones. The continued increase in use of personal mobile devices for 

clinician-clinician and clinician-patient communications requires administrative, physical and 

technical measures to safeguard PHI. Unfortunately, these measures can impede the convenience of 

this communication modality. 
173 


80806.134

\k Jim llialick 

Executive Director and CO-FOllUd(:f 

Nc\\hom Coalition 

750 9th Street, ~,W .. Suite 750 

\Vashingtoll, D.C :20001 

Ilear \'Ir. Bialick: 

fhnnk you 

w"tify at the hearing 

,\plil Fl. 2013 

Patients," 

Pursuant to the Rules oflhc CommiHee on Energy and Commerce, the hearing recol'd remains 

open It")f tell business to permit Members to submit additional qucstiOllS (hJ" the record, ,\"hit:h arc 

attached. The rormal responses to these ~houJd be as follows: (!) the name orthe 

J\<1cmbcr whose qW:$tion you are (2) text of the question you arc addressing in 

bold. and (3) your answer to thHt ql1csti-nn plain text. 

ro fUfililatc the printing of'lhc hearing record. piease to th~sc questions 

business on \Vcdncsday, April 2-l t 2013. Your r~:sponscs should e-mailcd to the 

Word l<)J"Inat at S;dnc,f lar\Vick~«":mail,housC.gD\ and mailed to Sydne llarwick, 

Committee on Energy ilnd ('<mullerCE', 2125 Ra) hurn Honse OBiee Building. 

Thank you again for your time and efTort preparing and delivering testimony before the 

Subcommillee. 

cc: The IIonorable Frank Paltonc~ Jr, Ranldng Member, SubcommiHee on Health 

Attachment 

of 
174 


80806.135

In Response to the Honorable Joseph R. Pitts: 

Question 1: During the hearing you said that regulation of mobile medical applications 

disproportionally affect certain patient groups. Would you please elaborate? 

Newborns will be disproportionately affected by the regulation of mobile medical applications. 

The development of traditional medical devices for newborns is a relatively small market. 

Technologies and devices designed specifically for newborns are inherently higher risk and are 

subject to significant regulatory oversight. Developers of these technologies incur non-trivial 

costs during the FDA regulatory process, which increases the up-front investment required to 

bring a product to market and lengthens the timeline for a product to become profitable. 

The high costs associated with bringing newborn-specific products to market have caused many 

medical device manufacturers shy away from designing products specifically for newborns. It is 

often the case that the exact same product can be brought to market with lower regulatory costs if 

the product is designated for use in adults. 

An example is the pulse oximeter, a FDA regulated medical device that is used to measure the 

level of oxygen in a patient's blood. This technology has an array of uses in newborns including 

the identification of hypoxia, neonatal sepsis, and congenital heart defects. To date, fourteen 

states and the District of Columbia have passed laws that require all newborns be screened using 

a pulse oximeter before they are discharged. However, despite the common use of this 

technology since its advent in 1972, it was not until 2012 that FDA cleared a pulse oximeter 

specifically designed for use in newborns. The forty years without newborn-specific pulse 

oximeters was not do to lack of demand, but rather it was because adult pulse oximeters could be 

used on newborns, albeit not as accurately, and the developers could bring the product to market 

with less regulatory scrutiny. 

In the absence of a product that has been developed specifically for newborns, families and 

providers have come to rely on technologies for which there is a market such as consumerfocused information and communication tools such as apps on smartphones and tablets. The 

question is not if some mobile applications should be regulated, certain mobile applications do 

present very real patient safety issues, but rather if all mobile applications should be regulated in 

the same way. 

My concern is if mobile medical apps are regulated the same way as medical devices are 

currently, then we can likely expect to see a reduction in the number of mobile medical apps that 

are designed specifically to serve newborns and their families. As demonstrated by the pulse 

oximeter, where there is a need the market will respond, but if there is an opportunity for a 

Newborn Coalition I www.newbomcoalition.org 
175 


80806.136

higher rate of return elsewhere, we must expect investment to flow to those areas first and that 

means fewer tools available to those that need them. 

Question 2: You stated in response to a question there are non-reimbursement barriers to 

telemedicine services that preclude their widespread use. Please specify what these nonreimbursement barriers are and how they might be addressed. 

Telemedicine has the ability to transcend geographic barriers but is often limited by bureaucratic 

issues such as state licensing. Currently providers have to be licensed in every state where they 

practice medicine, including telemedicine. If a provider physically located in the state where he 

or she is licensed, that provider cannot treat a patient via telemedicine that is located across state 

lines without first being licensed in both states. 

Telemedicine is a way for a provider to make a house call regardless of where the patient is 

located. The United States has long faced provider shortages in rural communities and we are 

now seeing shortages in the urban setting as well. Medicare beneficiaries will become 

increasingly aware of these shortages as more and more seniors seek healthcare and they are 

unable to find a provider. 

This problem can be solved by pursuing an approach similar to what the Veterans Administration 

and Department of Defense have done to address provider shortages great success: allow V A and 

DOD providers to treat patients regardless of where they are located. 

Something similar can be devised to address shortages in Medicare by allowing Medicare 

providers to treat their patients (those with whom they already have a relationship), regardless of 

where the patient located, and allow these providers to do so with their current state license. 

The Honorable Michael C. Burgess 

Question 1: The Health Information Management Systems Society Recommends that FDA not 

define "medical device" to cover software or hardware that provides clinical decision support, 

EHRs, simply transmits or allows other parties to read information originally sentjrom a 

medical device, or technologies that are widely used in other industries. These seem like a 

strong request that FDA not use mission creep to go into areas for which it has little expertise 

and little ability to properly review. 

a. How would FDA use a clinical trial system for clinical decision support? 

The process of using clinical trials to regulate clinical decision support (CDS) tools would be 

complex. The trial would have to be designed to investigate the efficacy of different kinds of 

CDS tools both as standalone interventions and as a part of a system. 

The issue of "mission creep" will become more apparent as CDS tools become more advanced 

and rely on individuals personalized health information instead of more fixed information sets 

such as drug formularies. 

Newborn Coalition I www.newborncoalition.org 
176 


80806.137

The concern here is that a CDS tool will have to be regulated as though it is a standalone medical 

device. This becomes increasingly complicated when we think of the EHR as being the central 

control for many CDS tools; the tools would then not only have to be individually regulated but 

also regulated as a device designed to work in concert with others. 

In this instance the regulation of CDS tools would likely extend to EHR developers as well if 

their systems use regulated CDS tools, because the system itself may be subject to additional 

regulation. CDS tools are already required for certification in the Meaningful Use program and 

have widely been incorporated into EHR systems. The concern here being that what began as 

the regulation of CDS tools may quickly lead to the regulation of the Electronic Health Record 

systems that Medicare providers have been required to purchase by the HlTECH Act. 

Newborn Coalition I www.newborncoalition.org 
177 


80806.050

RESPONSE TO QUESTIONS FOR THE RECORD 

HOUSE COMMITTEE ON ENERGY AND COMMERCE 

SUBCOMMITTEE ON HEALTH 

HEARING ON 

April 24, 2013 

HEALTH INFORMATION TECHNOLOGIES: How INNOVATION BENEFITS PATIENTS 

MARCH 20, 2013 

RESPONSE SUBMITTED BY 

JACQUELINE MITUS, MD 

McKESSON CORPORATION 

Question from Representative Michael Burgess: 

The Health Information Management Systems Society recommends that FDA not define 

"medical device" to cover software or hardware that provides clinical decision support, EHRs, 

simply transmits or allows other parties to read information originally sent from a medical 

device, or technologies that are widely used in other industries. These seem like a strong 

request that FDA not use mission creep to go into areas for which it has little expertise and 

little ability to properly review. 

a. How would FDA use a clinical trial system for clinical decision support? 

Response: 

We concur that medical devices, currently regulated by the FDA, are fundamentally different 

and distinct from clinical decision support in two important ways. 

First, the safety of a medical device is almost entirely dependent upon how it is manufactured. 

The safety of health IT on the other hand hinges upon how it is developed and, perhaps more 

importantly, on how it is deployed. Thus, health IT safety cannot be ensured simply through 

good manufacturing practices. 

Second, medical devices, unlike health IT, are directly involved in the treatment of a patient, 

with little if any opportunity for a clinician to intervene. The majority of medical software does 

not directly or independently act upon a patient, but rather provides data and guidance. The 

ability of a "learned intermediary" to utilize professional judgment distinguishes this technology 

from traditional medical devices. 
178 


80806.051

Consequently, clinical decision support, and health IT more broadly, is distinct from medical 

devices. The traditional paradigm of FDA regulation of medical devices is therefore not well 

suited to health IT, and a risk-based regulatory system similar to that advocated by the 

Bipartisan Policy Center is more appropriate. 

In the context of the oversight of health IT, clinical decision support systems refer to software 

applications which gather, present, and, to varying degrees, interpret and act upon information 

to assist clinicians in the diagnosis and treatment of patients. This is very different from more 

administrative software such as clinical trial software which may provide registries of clinical 

trials or which may manage eligibility and/or registration into trials. 

In some instances, physicians may utilize a clinical decision support system in the care of a 

patient who is participating in a clinical trial. It also is foreseeable that a clinical decision 

support system may utilize information obtained as a result of clinical trials, such as drug 

interactions or treatment recommendations associated with a medical device or 

pharmaceutical compound. However, it is difficult to envision a situation where the FDA would 

use a clinical trial system for clinical decision support in the context of the health IT discussion. 
179 


80806.138

Dr. David lVL Classen 

Pascal rv1ctrics 

Proressur of !vlcdicinc and 

Consultam in Infectious Di",eases 

l;tah School nft'd('dicil1c 

April 10. 201.l 

J 025 Th(Hllas. Jci1ersol1 Street. 1\. W.o Suit~ --12U East 

Washington. D.C 20007 

Deal' Dr. Classt'n: 

nefbre the Suhcommittee on l kalth on Wednesday. j'vlarch :20. 20! .1. to 

Informal ion I'cchnologic&: flow Innovation l-kndlts Patients.:' 

Pursuant to the Rules ofthu Commiuee on HHd Commerce. the hearing record remaius 

questions for the: record, wllicll arc 

should he as follows: (I) the name of the 

complete text oftht' question )on an: addressing in 

text, 

open f~)r h,'ll busin..:ss Jays to pt>nnit J\·1cmbcTs to submit 

attadlCd. The fbrnwt of your rcspons~s to these 

[vTcmbcl' \vhose que~tion jl,)lI arc 

bold. and (3) your an:.WN 11..1 that question 

hearing record. please respond to these 

business fln 201l Your n::spOHS\?S should he (;'wmailcd ti,) 

Word format nt ,all.llo"""g(lV and mailed to Svdn..: Harwick. 

Committee on l~ncrf!Y and Comm~rCt" 2125 House Office Building. 

Thank you again few your time and effort preparing and dclhcring, testimony before the 

Subcomrnitkc, 

l:C: The Honorable Fr.ank Pallone, Jr. Ranking ~\:le!llb\!r. Subcommittee on I fcalth 

}\lta~hmcllt 
180 


80806.139

Additional Questions for the Record 

The Honorable Michael C. Burgess 

1. In recommendation 9a of the report you cite, 10M states that if there is not 

sufficient progress, FDA should regulate electronic health records, health 

information exchanges, and personal health records. I want to ask about your 

understanding about why the 10M committee felt these items are medical devices 

within the purview of FDA. 

a. Let's start with health information exchanges. What about health 

information exchanges are medical devices? Is your view that devices 

that exchange medical records are medical devices within the purview of 

FDA? 

Please see response to lb. 

b. I am really trying to understand if the 10M believes that the entire health 

information architecture is a medical device. Can you start to tell me 

what software the committee did not consider a medical device? 

The 10M committee was asked to look specifically at "health IT-assisted 

care, " defined by ONe as including "care supported by and involving EHRs, 

clinical decision support, computerized provider order entry, health 

injormation exchange, patient engagement technologies. and other health 

information technology used in clinical care. " 

The 10M committee states on page 164 "health IT has multiple dif]erent 

characteristics {from conventional, out-ol-the box, turnkey devices], 

suggesting that a more flexible regulatory framework will be needed in this 

area to achieve the goal of product quality and sqfoty without unduly 

constraining market innovation" and calls for a "phased, risk-based 

approach" to regulation. The current model of medical device regulation, 

according to the committee, is insufficient for such complex products as health 

IT products. 

c. When the 10M Committee cites health information exchanges, what part 

of the definition of medical device is the Committee referring to? For 

example, are they saying a health information exchange is intended for 

use in the diagnosis of disease or other conditions? Or in the cure, 

mitigation, treatment, or prevention of disease? 

See response to 1 b. 
181 


80806.140

2. Page 140 of the {OM committee report states "The committee could not identify 

any definitive evidence about the impact regulation would have on the 

innovation of health IT." Yet the committee appears to recommend that FDA 

could jump in and regulate electronic health records, health information 

exchanges, and personal health records. 

a. What evidence is there about the impact that implementation of this 

recommendation would have on innovation in these areas? 

The 10M Committee believed that the evidence about the impact of regulation 

on health IT is unclear and could not be extrapolatedfrom the literature in 

other fields. The committee underscores the importance of protecting patient 

safety as the reason for making this recommendation and expresses the need 

for regulation to not restrict positive innovation or flexibility, but instead to 

maximize transparency. 

3. The 10M committee recommends an IDT error reporting system. There does 

not appear to be any discussion as to whether it is good to try to separate IDT 

issues from general care delivery system errors. 

a. Where is there evidence that you can separate HIT -related safety events 

from a category just called safety events? Is there not a danger in such 

separation oflosing an understanding of the real causes and solutions for 

such errors? 

The scope of the 10M Committee report was health IT-related patient saftty 

events, so the intent was not to create separate systems. The committee states 

on page 163 "If a broader system for all adverse events is created, the spirit of 

the committee's recommendations should be recognized and considered. " 

b. Can you give me an example of what you mean by an HIT -related safety 

error and how that does not involve non-hit issues? 

The 10M Committee believed that HIT-related safety errors are adverse events 

that are related to the design, implementation, and/or use of a health IT 

product. An example of an HIT-related safety error is presented on page 125: 

"a new kind of error that can occur with IT which did not occur previously is 

the 'acijacencyerror, ' in which a prOVider selects an item next to the one 

intended from a pUlldown menu, for example picking 'penicillamine' instead of 

'penicillin. '" Other examples /i'om the report include: 

• pick-list problem: selection of the wrong item from a menu of options, 

whether it be a patient, test, or drug per the above example of 

penicillamine/penicillin 

• alarm/alert problem: ignored alarms of potential problems 

• availability problem: system outages (e.g., during a prolonged power 

failure) where the EHR or other health IT products are unavailable 
182 

Æ 


80806.141

• interoperability problem: inverted images where the image of a right 

arm looks like that of a left arm