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

80–807 2013

HEALTH INFORMATION TECHNOLOGIES: ADMINISTRATION PERSPECTIVES ON INNOVATION AND 

REGULATION 

HEARING 

BEFORE THE

SUBCOMMITTEE ON OVERSIGHT AND 

INVESTIGATIONS 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

FIRST SESSION 

MARCH 21, 2013 

Serial No. 113–22 

( 

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 

ANTHONY D. WEINER, New York 

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 OVERSIGHT AND INVESTIGATIONS

TIM MURPHY, Pennsylvania 

Chairman 

MICHAEL C. BURGESS, Texas 

Vice Chairman 

MARSHA BLACKBURN, Tennessee 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

GREGG HARPER, Mississippi 

PETE OLSON, Texas 

CORY GARDNER, Colorado 

H. MORGAN GRIFFITH, Virginia 

BILL JOHNSON, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

JOE BARTON, Texas 

FRED UPTON, Michigan (ex officio) 

DIANA DEGETTE, Colorado 

Ranking Member 

BRUCE L. BRALEY, Iowa 

BEN RAY LUJAN, New Mexico 

EDWARD J. MARKEY, Massachusetts 

JANICE D. SCHAKOWSKY, Illinois 

G.K. BUTTERFIELD, North Carolina 

KATHY CASTOR, Florida 

PETER WELCH, Vermont 

PAUL TONKO, New York 

GENE GREEN, Texas 

JOHN D. DINGELL, Michigan 

HENRY A. WAXMAN, California (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Tim Murphy, a Representative in Congress from the Commonwealth 

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

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

Hon. Diana DeGette, a Representative in Congress from the state of Colorado, 

opening statement ................................................................................................ 4 

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

Texas, opening statement .................................................................................... 6 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee .............................................................................................................. 6 

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

California, opening statement ............................................................................. 7 

WITNESSES

Christy Foreman, Director, Office of Device Evaluation, Center for Devices 

and Radiological Health, Food and Drug Administration ................................ 9 

Prepared statement .......................................................................................... 12 

Answers to submitted questions ...................................................................... 61 

Farzad Mostashari, National Coordinator, Health Information Technology, 

U.S. Department of Health and Human Services ............................................. 21 

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

Answers to submitted questions ...................................................................... 66 

SUBMITTED MATERIAL

Letter of March 20, 2013, from the FDA to the Committee, submitted by 

Ms. DeGette .......................................................................................................... 57 

(1) 

HEALTH INFORMATION TECHNOLOGIES: 

ADMINISTRATION PERSPECTIVES ON INNOVATION AND REGULATION 

THURSDAY, MARCH 21, 2013 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 9:08 a.m., in room 

2322 of the Rayburn House Office Building, Hon. Tim Murphy 

(chairman of the subcommittee) presiding. 

Present: Representatives Murphy, Burgess, Blackburn, Harper, 

Olson, Griffith, Johnson, Long, Ellmers, Barton, DeGette, 

Butterfield, Tonko, and Waxman (ex officio). 

Staff present: Mike Bloomquist, General Counsel; Matt Bravo, 

Professional Staff Member; Karen Christian, Chief Counsel, Oversight; Andy Duberstein, Deputy Press Secretary; Julie Goon, 

Health Policy Advisor; Debbee Hancock, Press Secretary; Brittany 

Havens, Staff Assistant; Sean Hayes, Counsel, O&I; Robert Horne, 

Professional Staff Member, Health; Peter Kielty, Deputy General 

Counsel; Katie Novaria, Legislative Clerk; John O’Shea, Professional Staff Member, Health; David Redl, Counsel, Telecom; Alan 

Slobodin, Deputy Chief Counsel, Oversight; Jean Woodrow, Director, Information Technology; Tiffany Benjamin, Democratic Senior 

Counsel; Brian Cohen, Democratic Staff Director, Oversight & Investigations, Senior Policy Advisor; Eric Flamm, FDA Detailee; 

Elizabeth Letter, Democratic Assistant Press Secretary; Stephen 

Salsbury, Democratic Special Assistant; Rachel Sher, Democratic 

Senior Counsel; and Matt Siegler, Democratic Counsel. 

OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA 

Mr. MURPHY. All right. Good morning, everyone, and welcome to 

our hearing today on ‘‘Health Information Technologies: Administrative Perspectives on Innovation and Regulation.’’ Thank you for 

being here. Today, we convene the Subcommittee on Oversight and 

Investigations to discuss development and innovation and these 

technologies, particularly mobile medical applications or ‘‘apps,’’ 

and how federal regulations may impact this growing industry. 

We are joined by two witnesses from the Administration, Dr. 

Farzad Mostashari, who is the head of the Office of the National 

Coordinator with HHS; and Christy Foreman, who is the director 

2 

of the Office of Device Evaluation in the Center for Devices and Radiological Health at the FDA. Both of these agencies have been 

leading the government’s response to the rapid changes that new 

technologies are making to our Nation’s healthcare system. 

On March 4, this committee sent a letter to the FDA on its approach to regulating the rapidly growing market applications used 

on smartphones and tablets. With this explosive growth, the use of 

those apps to monitor health information is growing, as well as increasing in accuracy and technological sophistication. News reports 

indicate that there are as many as 40,000 medical applications on 

the market for smartphones and tablets. 

We are here today to discuss the discretion FDA has an regulating these apps as devices under the Food, Drug, and Cosmetic 

Act, and over the last few days, we have heard a number of examples of medical apps and concerns from apps companies about 

whether these apps are devices. For example, where does an app 

that transmits photos of potential skin cancer or the healing of surgical scars cross the line to FDA scrutiny? If an app that turns a 

smartphone into an ultrasound can be regulated, what about apps 

that let you review images from ultrasound or x-rays? 

You know, there has been incredible advances in all these things 

and we expect to see more in not only areas of dermatology in the 

use of photos, endocrinology with monitoring blood glucose levels, 

x-rays with radiology and orthopedics, heart monitors with cardiology, mental status tests with neurology. The list goes on and on. 

In 2011 the FDA issued Draft Guidance on how the Agency 

planned to regulate mobile medical applications. The FDA has not 

yet issued Final Guidance. To our witnesses from the FDA, over 

the last 2 days we have heard from a variety of witnesses and 

members of both sides of the aisle, and the message was clear: we 

need Final Guidance. The developers of these apps and the 

healthcare industry need certainty. 

That certainty is also needed because of the tax on medical devices put in place by the new healthcare law. As we have heard 

this week, a tax on medical devices can make capital needed to develop these apps and new breakthrough technologies more scarce. 

This can slow innovation. And we are caught in its cycle of the 

snake eating its own tail whereby we raise taxes on medical devices, thus increasing the costs, and then use those taxes to subsidize increased costs and offer tax incentives to cover R&D. It 

doesn’t quite make sense but we want to make sure we are not 

slowing innovation. 

So this isn’t about scaring people into thinking this tax will apply 

to their iPhones, Blackberries, or iPads, but this tax could absolutely halt the development of new apps to run on those devices. 

Everyone here recognizes the need to balance patient safety and innovation. I hope that today’s hearing will provide some certainty 

that regard. 

We will also hear from Dr. Mostashari on the efforts that have 

been made by the Department of Health and Human Services to 

encourage the utilization of health information technology, and particularly, the incentive payments that have been made to providers 

to adapt to new healthcare technologies. Recently, HHS announced 

that for this year they hope to have 50 percent of physicians’ offices 

3 

using electronic health records with 80 percent of eligible hospitals 

receiving incentive payments by the end of this year. 

While the movement to increased use of electronic health records 

may seem like an obvious choice as doctors and hospital employees 

become more comfortable with new technologies, as a supporter of 

health IT, I am concerned that the promised benefits of electronic 

medical records have yet to arrive. I have personally heard from 

physicians in my district who have struggled to adapt or received 

unclear Guidance from the Agency. Of particular concern are complaints that systems in place aren’t able to share information with 

other systems. I hope our witnesses today will be able to address 

these concerns over interoperability. 

I am encouraged by the work this committee has done this week. 

We have had a great dialogue on these issues and today I hope we 

will be able to hear the Administration’s view on its approach to 

innovation and regulation of healthcare technologies. 

I also want to apologize ahead of time. I have another hearing 

that I have to testify, and I will be leaving in a little bit, but it 

will be taken over by the capable hands of the vice chairman, Dr. 

Mike Burgess. 

[The prepared statement of Mr. Murphy follows:] 

PREPARED STATEMENT OF HON. TIM MURPHY

Today we convene the Subcommittee on Oversight and Investigations to discuss 

development and innovation in health care technologies, particularly mobile medical 

applications or ‘‘apps,’’ and how federal regulations may impact this growing industry. 

Today we are joined by two witnesses from the administration: Dr. Farzad 

Mostashari is the head of the Office of the National Coordinator within HHS. 

Christy Foreman is the Director of the Office of Device Evaluation within the Center for Devices and Radiological Health at FDA. 

Both of these agencies have been leading the government’s response to the rapid 

changes being made to the health care industry by new technologies. 

On March 4, this Committee sent a letter to the FDA on its approach to regulating the rapidly growing market for applications used on smartphones and tablets. 

With this explosive growth, the use of those apps to monitor health information is 

growing as well. News reports indicate that there are as many as 40,000 medical 

applications on the market for smartphones and tablets, and it is expected to grow. 

We are here today to discuss the discretion FDA has to regulate these apps as 

devices under the Food, Drug, and Cosmetic Act. I have seen that in today’s testimony the FDA is now definitely saying: NO, we will not regulate the general sale 

of smartphones or tablets-I thank the FDA for providing certainty on this matter. 

Yet, over the last few days we have heard a number of examples of medical apps 

and concerns from apps companies about whether these apps are devices. For example, where does an app that transmits photos of potential skin cancer cross the line 

to FDA scrutiny? If an app that turns a smartphone into an ultrasound can be regulated, what about apps that let you view images from an ultrasound or xray? 

In 2011, the FDA issued draft guidance on how the agency planned to regulate 

mobile medical applications. FDA has not yet issued final guidance. To our witness 

from the FDA, over the last two days we have heard from a variety of witnesses 

and members of both sides of the aisle-the message is clear: we need final guidance. 

The developers of these apps and the health care industry needs certainty. 

That certainty is also needed because of the tax on medical devices put in place 

by the new healthcare law. As we have heard this week, a tax on medical devices 

can cause money for the development of these apps and the advancement of medical 

technology to become more scarce. It can slow innovation. I’ve heard a lot from my 

Democrat colleagues about how we’re trying to scare people into thinking this tax 

will apply to their iPhones, Blackberries or iPads, but they don’t seem to be concerned that the problem is that it could halt the development of new apps to run 

on those devices. 

4 

1 1 http://www.hhs.gov/news/press/2013pres/03/20130306a.html 

Everyone here recognizes the need to balance patient safety and innovation. I 

hope that today’s hearing will provide some certainty on that balance. 

We will also hear from Dr. Mostashari on the efforts that have been made by the 

Department of Health and Human Services to encourage the utilization of health 

information technology, and particularly the incentive payments that have been 

made to providers to adapt to new health care technologies. Recently HHS announced that for this year they hope to have 50 percent of physician offices using 

electronic health records, with 80 percent of eligible hospitals receiving incentive 

payments by the end of the year. 1A1

While the movement to increased use of electronic health records may seem like 

an obvious choice as doctors and hospital employees become more comfortable with 

new technologies, this Committee is concerned whether their effectiveness has been 

oversold. In the last few months we have seen reports indicating that the savings 

promised by electronic health records may have yet to materialize while doctors 

struggle to adapt. Of particular concern are complaints that some of the systems 

being utilized may not be able to share information with other systems—and I hope 

our witness today will be able to address these concerns over interoperability. 

I am proud of the work this Committee has done this week—we have had a great 

dialogue on these issues and today I hope we’ll be able to hear the administration’s 

views on its approach to innovation and regulation of health care technologies. 

Mr. MURPHY. And now, I would like to recognize Ms. DeGette for 

her opening statement. 

OPENING STATEMENT OF HON. DIANA DEGETTE, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF COLORADO 

Ms. DEGETTE. Thank you very much, Mr. Chairman. 

Mobile medical apps and electronic health records are developing 

at a rapid pace and they have the capacity to transform the patient-doctor relationship, improve healthcare quality, and also to 

save billions of dollars. And I am looking forward to hearing from 

the FDA and HHS about the efforts to integrate these new technologies into the healthcare sector. 

Dr. Mostashari, I want to welcome you, the national coordinator 

for Health Information Technology. 

The 2009 stimulus bill contained billions of dollars to help 

incentivize doctors and hospitals to implement meaningful use of 

electronic medical records. That investment has already made a big 

difference. Since 2009, the use of electronic health records by physicians has doubled from 20 to 40 percent in the hospital adoption 

of electronic health records has more than tripled. More than 

230,000 healthcare providers have qualified for payments for implementing the use of electronic health records. Ultimately, the 

adoption of these records will reduce medical errors, save money, 

and most importantly, improve the quality of care. 

Earlier this week, the Premier Healthcare Alliance reported that 

333 hospitals in their network had, since 2008, save $9.1 billion 

and avoided 92,000 deaths by implementing a set of patient-centered quality improvement reforms that was made possible in part 

by enhanced data-sharing and use of health information technology. But the transition to electronic health records is not without challenges, and Dr. Mostashari, I am glad you are here to address questions about the Agency’s roadmap to help us fully implement health IT. 

5 

Ms. Foreman, I also want to welcome you to talk about the 

FDA’s role in regulating and improving mobile medical apps. 

Mr. Chairman, I have got to admit the discussion of FDA’s role 

in regulating medical apps seems a little redundant. This is the 

third hearing that is focused on these issues. As we heard during 

the first two hearings, the other subcommittee heard from 11 different nongovernment witnesses about how the Administration is 

balancing the need to promote innovation in this field against the 

need to ensure patient safety. Those witnesses thankfully already 

debunked some of the biggest myths that we have heard from the 

outside about the FDA’s role. Thank goodness the myth of the 

iPhone tax has now been put to rest. 

We also learned from the witnesses that smartphones and tablets 

are exempt from the Affordable Care Act medical device tax. We 

learned that the FDA is not currently and does not intend in the 

future to regulate smartphones or tablets as part of its regulation 

of mobile medical apps. We also learned that the FDA does not intend to regulate calorie counters or pedometers or other kinds of 

similar apps as medical devices. But we also learned about how the 

Agency has a role in ensuring that other medical devices like monitoring blood glucose or providing other vital medical information 

are accurate and work the way they are supposed to do, which is 

exactly what the FDA is therefore. 

But the Committee also heard from some industry witnesses expressing concerns about the FDA’s regulatory efforts and worrying 

that they could overreach and limit innovation. These concerns are 

not new and they are not specific to mobile medical apps. FDA, and 

frankly this committee, has to constantly address this balance, 

whether the Agency is regulating food, drugs, traditional medical 

devices, or these apps. That is part of what we have to do. 

The FDA addressed all of these concerns in a letter that was sent 

to the Committee yesterday and, Mr. Chairman, I would like to ask 

that the letter be made part of the hearing record. The letter 

makes it abundantly clear that the FDA will not tax your iPhone 

and it provides new information that shows for the mobile medical 

apps FDA has reviewed, those reviews are moving quickly, taking 

an average of only 67 days. So to me that sounds pretty much like 

an agency that is trying to foster innovation while at the same time 

ensuring that patients are safe. 

And so, Mr. Chairman, I don’t think that the debate over how 

to balance patient safety and innovation will end any time soon, 

but I am hopeful that at least we can have a common understanding of the facts with regard to electronic health records and 

mobile medical apps, and we can continue in our joint effort with 

the agencies to make sure we balance innovation and safety. 

And with that, Mr. Chairman, I yield back and thank you. 

Mr. MURPHY. Thank you. And we do have a copy of this letter 

for the record, but I thank the ranking member for bringing that 

up again. 

I now yield to Dr. Burgess for 5 minutes for an opening statement. 

6 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. I thank the chairman. And certainly we have 

heard from a number of qualified and distinguished scientists and 

specialists in medical technology and the communications industries for the past two hearings, and today, we are going to hear the 

perspectives of the agencies that wrote the proposed regulations 

guiding these industries. 

The emergence of mobile medical technology does hold great 

promise not only for lowering the care cost, but most importantly, 

for improving health outcomes. The increasing availability of these 

technologies has revolutionized how providers interact with patients. We are at a point now where the number of providers using 

these devices has increased, almost doubled, from a year ago such 

that nearly 2/3 of providers are using some type of device. The 

rapid proliferation of these new technologies also raises legitimate 

concerns about patient safety, but we also want to encourage important advancements that can improve patients’ quality of life. 

And it is not just the overregulation by the government but it is 

the uncertainty of pending regulation that also drives some of this 

discussion. 

The FDA struggles to maintain their current regulatory charge, 

but we need to be assured that they have the experience, that they 

have the expertise to handle the additional responsibilities of an 

emerging market. 

Ms. Foreman, I would like to thank you and your agency for the 

rapid response to the letter earlier this week. I hope that sets a 

new benchmark in the Administration. We are accustomed to waiting years for a response, and this was indeed refreshing that it was 

only a few weeks in turnaround. And certainly, we look forward to 

similar quick turnaround for the final regulations of the Draft 

Guidance, which was issued in July 2011. 

And Dr. Mostashari, I have enjoyed visiting with you in the past, 

and I thank you for being with us as well. 

As a provider, I have direct experience using health information 

technology and seeing the benefits as well as some of the downfalls 

that it brings to both patients and providers. Artificial barriers do 

nothing for care coordination, for patient safety, or for provider 

communication. As a physician, my primary concern is the health 

and safety of the patient. Inaction is not an option on this issue. 

However, we must do so in a way that encourages the development 

of innovative technologies, and we certainly do not want to push 

them outside of our borders. 

I will now yield the balance of the opening statement time to the 

gentlelady from Tennessee, Mrs. Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Mrs. BLACKBURN. And I thank the gentleman for yielding. And 

thank you, Mr. Chairman, for the hearing. And to our witnesses, 

Ms. Foreman, Dr. Mostashari, we thank you for being here with us. 

The hearings that we have done this week I think are essential. 

I don’t think they are redundant. I do think they are essential to 

7 

getting our arms around an issue that we are going to have to deal 

with on mobile medical apps. And I would say that one of the 

things that has come forward through the testimony we have received is that a 40-year-old FDA statute is not nimble enough to 

address the needs that are in front of us with this new innovation 

sector. 

I do think that ONC has a unique perspective on these HIT 

issues, and along with input from the FDA and from stakeholders 

that Congress can find a path forward on what a framework would 

look like. One of the things we have heard from the innovators is 

the uncertainty that is there within FDA. This big gray area of 

whether you will or will not be regulated, that is stifling innovation. And as we heard in the hearing on Tuesday, it also does not 

do anything to provide certainty to investors who are going to be 

there. So that is of concern to us. 

Now, Dr. Burgess mentioned yesterday that these are the tools 

of today’s doctors and future doctors, and 15 percent of these apps 

that are out there, the 97,000 apps, the mobile medical apps, 15 

percent are used by physicians. This is a way for us to achieve efficiency. It is a way for us to expand access, and what we want to 

be certain is that our innovators know with certainty what their 

classification would be, how they would be dealt with as an industry. 

So we thank you all for the testimony and for being here and we 

look forward to concluding our series and finding a way forward on 

the issue. 

And I yield back. 

Mr. MURPHY. Thank you. 

I now recognize the ranking member of the full committee for an 

opening statement, 5 minutes, Mr. Waxman. 

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

Mr. WAXMAN. Mr. Chairman, we are here today for the third day 

in a row to discuss electronic health records and FDA’s regulation 

of mobile medical apps, and I am surprised at the amount of time 

and attention given to this issue. 

I have attended the last 2 days of hearings, and from what I 

have heard, the members on your side of the aisle seek to answer 

two basic questions: question one, whether the FDA is regulating 

mobile medical apps with too heavy a hand; is the Agency impeding innovation and harming this market by regulating too aggressively or approving mobile medical apps too slowly? 

This is not a new responsibility for FDA. For over 100 years the 

Agency has been balancing patient and consumer safety with the 

need for innovation. In the case of mobile medical apps, the answers that we heard in the first 2 days of hearings indicate little 

by way of concern. The witnesses told us that they understood the 

role of FDA and the need for agency regulation and were unable 

to point out any legitimate examples of apps that FDA was improperly regulating under its Draft Guidance. Although they had some 

anxiety about it, they had nothing to point to. 

8 

Question two is whether FDA will impose a new tax, the Affordable Care Act medical device tax, on your cell phone. The answer 

to this question is as plain as day. The answer is no. The Affordable Care Act itself contains a clear retail exemption. Even if a cell 

phone was designated to be a medical device, the Act says that any 

device that is ‘‘generally purchased by the general public at retail 

for individual use’’ is not subject to the tax. That exemption would 

apply to any cell phone you can buy at a retail store. And FDA has 

been clear that the Agency is not currently regulating and does not 

intend in the future to regulate smartphones or tablets as part of 

its regulation of mobile medical apps. The IRS has provided similar 

indications. 

Mr. Chairman, this issue is a non-issue. We did not need to 

spend 1 day of hearings on this, let alone 3. This committee could 

have used this time more wisely. I have asked you to hold hearings 

on the abuse of tax and regulatory loopholes by the tobacco industry and their efforts to undermine the Tobacco Control Act. Ranking Member DeGette and I have asked for hearings on the impacts 

of sequestration on the agencies of our committee’s jurisdiction. We 

have asked for hearings on the risks associated with antibiotic-resistant bacteria, a very serious and growing public health threat. 

We have asked for you to hold hearings on Lifeline, the Universal 

Service Fund’s low income phone program. These hearings could 

examine the expenditure of billions of dollars of consumer funds. 

In the last 2 years, I have sent over 20 letters asking for hearings on the impacts of climate change. And we have not held a 

hearing on a single one of these important issues. Mr. Chairman, 

I hope you can understand our concern. I don’t mean to discount 

the importance of mobile medical apps and the electronic health 

records. This is an industry that, thanks to the investment we 

made in the 2009 Obama stimulus bill, is growing, is creating jobs, 

and has the potential to dramatically improve healthcare quality 

and save billions of dollars in healthcare costs. 

But there are too many pressing issues before us for this committee and this Congress to get bogged down for 3 days in what 

amounts to an inaccurate talking point about FDA overregulation 

and the nonexistent iPhone tax. I hope that in the future this subcommittee can use its time more wisely. I must say, Mr. Chairman, 

for this particular subcommittee, I thought that the first hearings 

we have held under your leadership have been very worthwhile 

and that we can go back to doing things that are constructive and 

not just talking points for political purposes, which is all these 3 

days have been about. 

I yield back the balance of my time. 

Mr. MURPHY. Thank you very much, Mr. Waxman. I would now 

like to recognize Christy Foreman. She is currently the director of 

the Office of Device Evaluation for the Center for Devices and Radiological Health for the FDA. Before being named to the director 

position, she served as the deputy director for Science and Regulatory Policy in the Office of Device Evaluation. 

I would also like to introduce Farzad Mostashari. He currently 

serves as national coordinator for Health Information Technology 

within the Office of the National Coordinator for Health InformaVerDate Nov 24 2008 14:46 Jun 19, 2013 Jkt 037690 PO 00000 Frm 00014 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-22 CHRIS
9 

tion Technology at the U.S. Department of Health and Human 

Services. Farzad joined ONC in July of 2009. 

You are aware that the Committee is holding an investigative 

hearing, and when doing so, has had the practice of taking testimony under oath. Do you have any objections to testifying under 

oath? 

Both witnesses have said they do not. 

The chair then advises you that under the rules of the House and 

the rules of the Committee, you are entitled to be advised by counsel. Do you desire to be advised by counsel during your testimony 

today? 

Both witnesses have said no. 

In that case, if you please rise and raise your right hand, I will 

swear you in. 

[Witnesses sworn.] 

Mr. MURPHY. And if someone could work on the volume, I would 

appreciate that, too. 

You are now under oath and subject to the penalties set forth in 

Title XVIII, Section 1001 of the United States Code. You may now 

give a 5-minute summary of your written statements. Ms. Foreman, if you would like to begin. 

TESTIMONY OF CHRISTY FOREMAN, DIRECTOR, OFFICE OF 

DEVICE EVALUATION, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION; AND 

FARZAD MOSTASHARI, NATIONAL COORDINATOR, HEALTH 

INFORMATION TECHNOLOGY, U.S. DEPARTMENT OF HEALTH 

AND HUMAN SERVICES 

TESTIMONY OF CHRISTY FOREMAN 

Ms. FOREMAN. Mr. Chairman, Ranking Member DeGette, and 

members of the subcommittee, I am Christy Foreman, Director of 

the Office of Device Evaluation in the Center for Devices and Radiological Health, or CDRH, at the Food and Drug Administration. 

Thank you for the opportunity to testify today. I am pleased to be 

here to discuss issues related to health IT and to talk specifically 

about the actions FDA is taking to foster innovation in the field of 

mobile medical applications, also referred to as mobile medical 

apps. 

The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and healthcare delivery. Mobile apps, which are software programs that run on 

smartphones and other mobile devices, can help consumers and patients manage their own health and wellness, promote healthy living, and gain access to useful information when and where they 

need it. 

FDA believes it is important to adopt a balanced approach to mobile medical apps that supports continued innovation while assuring appropriate patient protections. We also recognize that mobile 

health application developers need a clear, predictable, and reasonable understanding of the Agency’s expectations. 

While many mobile apps carry minimal risk, others can pose significant risk to patients if they don’t operate correctly. In some 

cases, those risks are identical to the risks associated with an alVerDate Nov 24 2008 14:46 Jun 19, 2013 Jkt 037690 PO 00000 Frm 00015 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-22 CHRIS
10 

ready marketed medical device. For example, a mobile app that affects the programming of a drug infusion pump or a Computed Tomography scanner could lead to a drug or radiation overdose. And 

an inaccurate or malfunctioning mobile medical app designed to diagnose skin cancer could delay life-saving diagnosis and treatment. 

In July 2011, FDA issued a Draft Guidance announcing our intention to exercise enforcement discretion for most mobile apps. 

The Guidance also clarifies that the focus of our oversight will be 

a small subset of mobile apps, which we refer to as ‘‘mobile medical 

apps.’’ These are apps that meet the definition of a device in the 

Federal Food, Drug, and Cosmetic Act and that are either intended 

to be used as an accessory to a regulated medical device or transform a mobile platform into a regulated medical device. 

What our policy proposes is equally important as what our policy 

does not propose. It would not regulate the sale or general consumer use of smartphones or tablets. It would not consider entities 

that exclusively distribute mobile medical apps, such as the iTunes 

App Store or the Android Market, to be medical device manufacturers. It would not consider mobile platform manufacturers to be 

medical device manufacturers just because their mobile platform 

could be used to run a mobile medical app regulated by FDA. It 

would not require mobile medical app developers to seek agency reevaluation for minor iterative product changes. And it would not 

apply to mobile apps that perform the functionality of an electronic 

health record, an EHR system, or personal health record system. 

We have received more than 130 written comments on our Draft 

Guidance. The comment have been overwhelmingly supportive of 

our narrow, tailored, risk-based approach, and we continue to receive many inquiries from industry stakeholders who are eager to 

see this Guidance finalized. Some commenters have sought additional clarity on the types of mobile apps that would fall within the 

scope of enforcement discretion. Our Final Guidance will provide 

that additional clarity and examples. 

Pursuant to Section 618 of the Food and Drug Administration 

Safety and Improvement Act (FDASIA), the FDA, the Office of the 

National Coordinator, and the Federal Communications Commission have established a FDASIA workgroup which will provide expert input from a wide range of stakeholders to develop recommendations on an appropriate, risk-based regulatory framework 

pertaining to health information technology, including mobile medical apps. 

It is important to note that FDA has been regulating medical device software for decades, and medical device software on mobile 

platforms for more than 10 years. We have reviewed approximately 

100 mobile medical apps, including remote blood pressure, heart 

rhythm, and patient monitor apps in addition to smartphone-based 

ultrasound and glucose meters. 

We recognize the importance of using a balanced, transparent 

approach that fosters the development of innovative mobile medical 

apps while ensuring appropriate patient protections. We intend to 

strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps 

that present a serious potential risk to patients if they do not work 

as intended. We believe that focusing the Agency’s oversight will 

11 

encourage the development of new products while also providing 

appropriate patient protections. 

Thank you for the opportunity to testify today about issues related to health IT, including mobile medical apps, and about the 

actions FDA is taking to foster innovation. 

Mr. Chairman, I commend the Subcommittee’s efforts and am 

pleased to answer any questions the Subcommittee may have. 

[The prepared statement of Ms. Foreman follows:] 

12 


80807.001

HEALTH Al\D Hl'MAN SERVICES Public Health Service 

STATEMENT 

OF 

CHRISTY L. FOREMAN 

DIRECTOR, OFFICE OF DEVICE EVALUATION 

CENTER FOR DEVIC.ES AND RADIOLOGICAL HEALTH 

FOOD AND DRUG ADMINISTRATION 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

BEFORE THE 

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS 

COMMITTEE ON ENERGY AND COMMERCE 

U.S. HOUSE OF REPRESENTATIVES 

"HEALTH INFORMATION TECHNOLOGIES: 

20993 

ADMINISTRATION PERSPECTIVES ON INNOVATION AND REGULATION" 

l\farch 21, 2013 

Release Only On Delivery 
13 


80807.002

INTRODUCTION 

Chairman Murphy, Ranking Member DeGette, and Members of the Subcommittee, I am Christy 

Foreman, Director of the Office of Device Evaluation in the Center for Devices and Radiological 

Health (CDRH) at the Food and Drug Administration (FDA or the Agency). I am pleased to be 

here today to discuss issues related to health information technology (health IT), and to talk 

specifically about the actions FDA is taking to foster innovation in the field of mobile medical 

applications (mobile medical apps). 

Health IT serves as the fundamental infrastructure that enables the management of health 

information across multiple electronic systems and devices, such as wireless medical devices, 

hospital information systems, communications infrastructures, and electronic health record 

(EHR) systems. 

The widespread adoption and use of mobile technologies is opening new and innovative ways to 

improve health and health care delivery. Mobile applications (mobile apps)-software programs 

that run on smartphones and other mobile communications devices--can help consumers 

manage their own health and wellness, promote healthy living, and gain access to useful 

information when and where they need it. Not surprisingly, these tools are being adopted almost 

as quickly as they can be developed. In fact, industry estimates that 500 million smartphone 

users worldwide will be using a health care application by 2015, I and by 2018, 50 percent of the 

hcalthcarc mobile al'l""""'''''' in 20lS" (Nov. 10,2(10), 

]Ot5. 
14 


80807.003

more than 3.4 billion smartphone and tablet users will have downloaded mobile health 

applications.2 Thcse users include health care professionals, consumers and patients. 

FDA believes it is important to adopt a balanced, approach to mobile medical apps that supports 

continued innovation, assuring appropriate patient protections. We also recognize that mobile 

health application developers and manufacturers need a clear, predictable, and reasonable 

understanding ofthe Agency's expectations. 

Mobile apps span a wide range of health functions. While many mobile apps cany minimal or 

no risk, others can pose significant risks to patients if they don't operate conectly. And, as we 

will discuss, FDA's proposed guidance takes this variation in risk into account. 

Consumers use mobile apps to manage their own health and wellness, such as to monitor their 

caloric intake for healthy weight maintenance, or like the National Institutes of Health's 

LactMed app, to provide nursing mothers with infom1ation about the effects of medicines on 

breast milk and nursing infants. Other apps are aimed at helping health care professionals to 

improve and facilitate patient care. such as the Radiation Emergency Medical Management 

(REMM) app. which gives health care providers guidance on diagnosing and treating radiation 

injuries. Some mobile apps can even diagnose cancer or heart rhythm abnormalities, or function 

as the "central command" for a glucose meter used by an insulin-dependent diabetic patient. 

Consumers and health care professionals should be aware of the potential benefits and risks 

associated with technologies that incorporate mobile apps. In some cases those risks are similar 

or identical to the risks associated with an already-marketed medical device. As an example. 

2 Research2Guidance, "Mobile Health Market RcporI2013-20l7: The Commercialization ofmHealth Applications" 
15 


80807.004

mobile apps that aHcct the programming of a drug infusion pump or computed tomography (CT) 

scanner could lead to a drug or radiation overdose. An inaccurate or malii.mctioning mobile 

medical app that uses a sensor to diagnose skin cancer or to measure critically low blood oxygen 

levels in chronic lung disease patients, could delay lifesaving diagnosis and treatment. 

FDA's 2011 Draft Guidance and Public Meeting 

FDA has jurisdiction over those mobile apps that meet the definition of "device" in section 

201(h) of the Federal, Food, Drug. and Cosmetic Act (FD&C Act) and the Agency intends to use 

this authority reasonably and judiciously. FDA issued draft guidance in July 2011 3 to announce 

its intention to exercise enforcement discretion for most mobile apps. The guidance also clarifies 

that the focus ofFDNs oversight will be the small subset of mobile apps, referred to as mobile 

medical apps, that meet the definition of "device" in section 201 (h) of the FD&C Act and that 

are either intended to: (I) be used as an accessory to a regulated medical device,4 ill (2) 

transform a mobile platform into a regulated medical device.5 This narrowly tailored approach 

would not require active FDA oversight of many apps that would otherwise meet the definition 

of "device." Our draft guidancc clarified that a currently regulated medical device would not 

become unregulated just because it was designed to work on a mobile platform. For example, 

medical ultrasounds and electrocardiogram (EKG) machines are medical devices subject to FDA 

review whether or not they are on a mobile platform. We believe that focusing FDA oversight 

(March 4. 2013), available at 

http,"~ 11'wH',l'esearch2guidal1ce,com "hop inde.r.()hp downloadable download sample sample td 262 . 

3 FDA, "Draft Guidance for Industry and Food and Drug Administration Staff - Mobile Medical Applications" (July 

21, 20 I I). available at 

an a cure professional to make a 

medical image Jeom a picture archiving and communication system (PACS) on a smarttlho.ne 

5 For example, an application that turns a smartphonc into an electrocardiograph 

hear( rhythms or to detcrmine if a patient is experiencing a heart attack. 
16 


80807.005

on a narrow subset of mobile apps will encourage the development of new products while 

providing appropriate patient protections. 

Just as important as what the policy proposes is what the policy does not propose. FDA's 

proposed mobile medical apps policy would not regulate the sale or general consumer use of 

smartphones or tablets. FDA's proposed mobile medical apps policy \vould not consider entities 

that exclusively distribute mobile medical apI's, such as the owners and operators of the "iTunes 

ApI' store" or the "Android market," to be medical device manufacturers. FDA's proposed 

mobile medical apps policy would not consider mobile platlorm manufacturers to be medical 

device manufacturers just because their mobile platform could be used to run a mobile medical 

app regulated by FDA. FDA's proposed mobile medical apps policy would not require mobile 

medical app developers to seek Agency re-evaluation for minor. iterative product changes. 

FDA's proposed mobile medical app policy would not apply to mobile apI's that perform the 

functionality of an electronic health record (EHR) system or personal health record system. 

The draft guidance also states the Agency's intent to exercise enforcement discretion for those 

mobile apps that do not meet the proposed definition of a mobile medical app, even if the mobile 

app meets the FD&C Act's definition ofa "device." 

Throughout the development of the mobile medical apps draft guidance and following its 

issuance in July 2011. FDA has actively encouraged public feedback on how the regulatory 

approach proposed in the draft guidance would affect the balance between promoting innovation 

and providing reasonable assurance of safety and effectiveness. In addition to opening the draft 

guidance for public comment, the Agency has interacted with the stakeholder community. 

including traditional medical device finns, software companies, health care professionals, patient 
17 


80807.006

advocacy groups. health care facilities. third-party payers, and the health IT community. FDA 

also hosted a widely attended public meeting to provide a forum tor discussion and to encourage 

additional public comment from interested stakeholders on the issues raised in the draft 

guidance.6 

In total, FDA has received more than 130 submissions to the public docket on the July 20 II draft 

guidance. Respondents have overwhelmingly supported the narrowly tailored, risk-based 

approach described in the draft guidance, and we continue to receive many inquiries from 

industry stakeholders who are eager to see the guidance finalized. Some commenters have 

sought additional clarity on the types of mobile apps that would fall within the scope of 

enforcement discretion; the final guidance will provide such additional clarity and examples. 

It is important to note that FDA has been regulating medical device software for decades and 

medical device software on mobile platfonns for more than 10 years. The Agency has reviewed 

approximately 100 mobile medical apps. including remote blood pressure, heart rhythm, and 

patient monitors, and smartphone-based ultrasounds, EKG machines, and glucose monitors. 

Some have questioned the implications of the medical device excise tax (device tax) enacted as 

part ofthe Health Care and Education Reconciliation Act of2010 in cOI\junction with the Patient 

Protection and Affordable Care Act for mobile medical apps. The Internal Revenue Service 

(IRS) and the Department of the Treasury, not FDA. are responsible for the excise tax imposed 

on the sale of certain medical devices. The IRS' final regulations 7 pertaining to the device tax 

define a taxable medical device as "a device that is listed as a device with the FDA under 5100) 

12-13.2011." available at 
18 


80807.007

of the FFDCA and 21 CFR Part 80T' and provide a "retail exemption" for medical devices that 

are "generally purchased by the general public at retail for individual use." Questions about the 

implementation of this policy should be directed at the IRS. 

FDA developed the Agency's draft mobile medical apps policy to protect public health and 

promote innovation. Because the draft guidance states that the Agency intends to exercise 

enforcement discretion for certain categories of mobile apps with respect to applicable device 

requirements. including listing. FDA does not expect such devices to list. FDA plans to provide 

additional clarity regarding the specific types of apps for which the Agency intends to exercise 

enforcement discretion in the final mobile medical apps guidance. The Agency intends to 

maintain a publicly available website with updated information listing those apps which have 

been cleared or approved by FDA and those for which FDA intends to exercise enforcement 

discretion, in order to provide continuing clarity on this issue for industry and other stakeholders. 

Developing an Appropriate, Risk-based Regulatory Framework for Health IT 

Mobile medical apps represent just one component in an increasingly connected health care 

environment. Three federal agencies-FDA, the Office of the National Coordinator for Health 

Information Technology (ON C), and the Federal Communications Commission (FCC)-each 

have unique and complementary responsibilities in the health IT arena. Section 618 of the Food 

and Drug Administration Safety and Innovation Aet (FDASIA), enacted on July 9, 2012, 

requires the Secretary of Health and Human Services, acting through the Commissioner of Food 

and Drugs and in consultation with the National Coordinator for Health IT and the Chairman of 

FCC, to prepare a report by January 2014 containing "a proposed strategy and recommendations 
19 


80807.008

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.',g 

FDA, ONC, and FCC have estahlished a "FDASIA Workgroup" under ONe's Health IT Policy 

Committee (HITPC)9, which will provide expert input to ONe's HITPC to inform the 

development of this report. Like ONC's other workgroups, it will be comprised ofa wide range 

of stakeholders and conducted in a transparent manner with ample opportunity for public 

comment. 

CONCLUSION 

FDA recognizes the importance of implementing a balanced, transparent approach that fosters 

the development of health IT solutions and innovative products like mobile medical apps, while 

ensuring appropriate patient protections, Like traditional medical devices, mobile medical apps 

may in some cases present significant health risks to patients, FDA seeks to strike the right 

balance by providing a risk-based, focused approach to the oversight o1'a small subset of mobile 

medical apI's that present a potential risk to patients ifthey do not work as intended. Consistent 

with this balanced approach, FDA would not regulate the sale or general consumer use of 

smartphones or tablets. 

8 Food and Drug Administration Safety and Innovation Act Public Law 112-144(126 Stat. 993) (July 9, 2012), 

available at hllp: '11.",11'. gpo. go" fd'l's pkg PL.! 11'-1 npuN N~ pdfFL..! W-112puhlI 4.f.pdt: 

q See FCC, "Membership Applications Sought for FDA Satety Innovation Act Workgroup," available at 

http.-,','www(cc.gor membershiD-applicatio!1s-sought-fda-safetl'-innol'atiQI1-act-l-l'orkgroup. The Workgroup is being 

formed under the ONC's HlTPC , a federal advisory committee established by the Health Information Technology 

for Economic and Clinical Health (HITECll) Act (Title Xllf of the American Recovery and Reinvestment Act. 

Public Law 111-5 (123 Stat. 115)(Feb. 17,2009). available at I!i.UL_11J11l',iJPO.!J,ITJsLIT5J2.kgPLAWI I Ipubl5 pdfPLAW-I I Ipuh/5.pd[. 
20 


80807.009

In its regulation of medical devices, the Agency strives for transparency, interaction, 

collaboration, and the appropriate balancing of benefits and risks; ensuring predictable and 

consistent recommendations, decision-making, and application ofthe least-burdensome 

principle; and implementing efficient processes and use of resources. FDA's ongoing actions 

with respect to the regulation of mobile medical apps. and the tri-Agency collaborative effort on 

health IT, reflect this regulatory approach. 

Thank you for your commitment to the mission of FDA and the continued success of our medical 

device program, which helps to ensure that patients and health care professionals have access to 

safe and effective innovative medical technologies. Thank you for the opportunity to testify 

today about issues related to health IT, including mobile medical apps. and about the actions that 

FDA is taking to foster innovation. I am happy to answer questions you may have. 
21 

Mr. BURGESS [presiding]. The chair thanks the witness. I recognize Dr. Mostashari, 5 minutes for your opening statement, sir. 

TESTIMONY OF FARZAD MOSTASHARI 

Dr. MOSTASHARI. Dr. Burgess, Ranking Member DeGette, distinguished subcommittee members, thank you for the opportunity to 

appear today on behalf of the Department of Health and Human 

Services. My name is Dr. Farzad Mostashari. I am the National 

Coordinator for Health Information Technology. 

In 2009, HITECH was enacted as part of the American Recovery 

and Reinvestment Act. HITECH provided the resources and infrastructure needed to stimulate the rapid, nationwide adoption and 

use of health IT, especially electronic health records, or EHRs. 

HITECH is working. The CMS Medicare and Medicaid EHR Incentive Program, the ONC-led Certification Program for EHRs, as well 

as the hands-on technical assistance provided by 62 regional extension centers, or RECs, across the country are critical in facilitating 

unprecedented progress in EHR development, adoption, and use. 

There are now over 1,700 unique products produced by nearly 

1,000 EHR developers and certified by 1 of 5 ONC-accredited private sector certification bodies. Adoption of EHRs has doubled 

among providers and more than tripled in hospitals. Electronic prescribing has increased sevenfold. RECs have signed up more than 

130,000 primary care providers in over 30,000 practices. As of February 2013, more than 230,000 providers, nearly 43 percent of the 

Nation’s eligible professionals, and over 75 percent of eligible hospitals have earned payments for meeting the initial requirements 

of EHR Incentive Program. 

Recognizing the need to strike a balance between the urgency of 

modernizing our healthcare system and the pace of change that can 

be safely absorbed, CMS and ONC have developed the Incentive 

Program in stages. Each stage is designed to add increasingly advanced concepts. Published in July 2010, the Stage 1 final rules focused on functionality that support the electronic capture of data 

and its use to improve patient care, enhance care coordination in 

population health management, and increase patient and family 

engagement. The final rules for Stage 2 were published in September 2012 and represent an important next step with a focus on 

increasing standards-based health information exchange between 

providers and with patients. 

Even as we work to bring data and data tools to doctors and hospitals, we have also been encouraged by the pace of progress in the 

domain of consumer e-health tools. Increasingly, people are literally taking their health into their own hands. Mobile phones can 

be an incredible tool for empowering consumers to take control of 

their health, their care, their healthcare finances. And as we all 

know, more engaged consumers get better outcomes. 

ONC’s strategy in consumer e-health is to work with partners to 

increase patients’ ability to access their own health data, to increase the use of this data for actionable apps and services, and to 

shift attitudes around patient empowerment. However, we recognize there are risks as well as benefits to any technology. We must 

carefully balance the need for the widest possible innovation with 

protection of patient privacy, security, and safety. 

22 

Over the past 4 years, we have worked with FDA and other departmental agencies on a risk-based approach to health IT that 

promotes innovation and avoids regulatory duplication. ONC advised FDA on the Draft Guidance for mobile medical apps. Where 

it concerns EHR technologies, FDA has advised us on a health IT 

patient safety action and surveillance plan, the draft of which was 

released on December 21, 2012. The draft plan prescribes actions 

that all stakeholders can take within their existing authorities and 

resources, including safety requirements related to user-centered 

design quality management systems and easier reporting of adverse events in ONC regulations, use of ONC-authorized testing 

and certification bodies to collect complaints and conduct surveillance, working with developers to establish a code of conduct, working with AHRQ and patient safety organizations to improve aggregation and analysis of reported events and working with CMS to 

train surveyors and use health IT to assist investigations. ONC has 

received public comments on the draft plan, and those comments 

have been generally favorable. 

On February 20, ONC, FDA, and FCC announced the formation 

of the Food and Drug Administration’s Safety Innovation Act Work 

Group under ONC’s Health IT Policy Committee to provide expertise for the development of a congressionally mandated report on 

an appropriate risk-based regulatory framework pertaining to 

health IT broadly, including mobile medical applications that will 

further promote innovation, protect patient safety, and avoid regulatory duplication. We are now in the process of reviewing nominations. 

New technologies, including health IT and mobile applications, 

offer great promise to improve the quality of care and bring down 

healthcare costs. This doesn’t happen overnight. To truly transform 

delivery, healthcare providers must also redesigned workflows and 

reengineer care. Payments must promote value over volume and 

care that is better coordinated and safe. Implementation of any 

program of this scale and complexity will inevitably include challenges, but by working within an open and transparent process and 

in partnership with our public and private sector stakeholders, we 

can build on this strong start in bringing better care to all Americans. 

Thank you. 

[The prepared statement of Dr. Mostashari follows:] 

23 


80807.010

Testimony before the Subcommittee on Oversight 

and Investigations 

Committee on Energy and Commerce 

U.S. House of Representatives 

Statement of 

Farzad Mostashari, M.D., ScM. 

National Coordinator, Office of the National Coordinator for 

Health Information Technology 

U.S. Department of Health and Human Services 

Health Information Technologies: 

Administration Perspectives on Innovation and Regulation 

March 21, 2013 
24 


80807.011

Chairman Murphy, Ranking Member DeGette, and distinguished Subcommittee 

members, thank you for the opportunity to appear today on behalf of the Department of 

Health and Human Services (HHS). My name is Dr. Farzad Mostashari and I am the National 

Coordinator for Health Information Technology. 

In 2009, Congress and President Obama enacted the Health Information Technology for 

Economic and Clinical Health Act (HITECH) as part of the American Reinvestment and Recovery 

Act of 2009 (ARRA). HITECH established the Office of the National Coordinator for Health 

Information Technology (ONe) by law and provided the resources and infrastructure needed to 

stimulate the rapid, nationwide adoption and use of health IT, especially electronic health 

records (EHRs). Among other measures, HITECH included the establishment of the Medicare 

and Medicaid EHR Incentive programs which provide technical assistance and financial 

incentives to eligible professionals and hospitals that adopt and "meaningfully use" EHRs. 

Thank you for the invitation to be here today to discuss how health IT benefits 

patients and provides the tools that are necessary to transform care. Already, HHS and its 

partners have made significant progress expanding health information technology use. 

Since 2009 physician EHR adoption has nearly doubled, growing to 40 percent in 2012, and 

hospital EHR adoption has more than tripled over the same period, increasing to 44 percent. 

In addition, I would like to provide a status report on HHS's Patient Safety Action & 

Surveillance Plan and an update on the progress we have made in the relatively short time 

since HITECH's passage. Finally, I will conclude with an overview for what we have planned 

in 2013 and beyond. 

2 
25 


80807.012

Health IT is Transforming Care 

Technology is just a tool but it is a critical tool that can foster much-needed 

innovation in entrenched industries. Our healthcare system is poised for a transformation 

in how care is paid for and delivered and how patients engage in their own health and health 

care. Health information technology supports these transformations. 

In the past, our healthcare delivery system based its payments solely on the number of 

services provided and not on the quality of care. As a result, patients might receive 

duplicative tests and/or services that might not improve their health. As required by the 

Affordable Care Act, HHS has launched several initiatives to more closely link payments with 

quality outcomes and promote value-based care.1 For example, the hospital readmissions 

reduction program links hospital payments in Medicare to avoidance of potentially preventable 

readmissions. These reforms enable HHS to promote value over volume, and patient safety, 

and ensure that care is better coordinated across the healthcare delivery system. 

As both public and private payers take concrete steps to change the incentives for 

paying providers, health IT can provide the infrastructure for improved care coordination, 

better quality, and lower costs, as well as the data analytics that providers need to understand 

the cost of doing business under the new payment models. 

1 See Statement of Jonathan Blum on Delivery System Reform: Progress Report from eMS: Senate Committee 

on Finance, February 28, 2013. 

3 
26 


80807.013

Federal Advisory Committees: The HIT Policy and Standards Committees 

Recognizing that health IT is a complex and quickly changing field, HITECH established 

two Federal advisory committees under the Federal Advisory Committee Act (FACA). The 

Health IT Policy Committee was created to make recommendations on a policy framework to 

support the development and adoption of a nationwide health information infrastructure. 

The Health IT Standards Committee is responsible for making recommendations on standards, 

implementation specifications, and certification criteria for the use and exchange of health 

information. 

Both the HIT Standards Committee and HIT Policy Committee include experts from the 

private sector to help guide ONC and the Centers for Medicare & Medicaid Services (CMS) in 

developing the rules for meaningful use and the certification of EHR technology. HITECH 

specified the different stakeholder perspectives that must be represented on the Committees. 

The law explicitly charged the Comptroller General of the United States with the responsibility 

of appointing 13 members representing various stakeholder groups to the Health IT Policy 

Committee. Additional perspectives are provided by the members appointed by the Secretary 

of Health and Human Services, the Majority and Minority Leaders of the Senate, and the 

Speaker and Minority Leader of the House of Representatives. HITECH further specified that 

the Health IT Standards Committee include providers, ancillary healthcare workers, consumers, 

purchasers, health plans, technology vendors, researchers, relevant Federal agencies, and 

individuals with technical expertise on health care quality, privacy and security, and health 

information exchange. 

4 
27 


80807.014

To further enrich the advice they provide, each Committee maintains several 

workgroups that incorporate the perspectives of additional stakeholders from government and 

the private sector. Since the creation of the Committees, their members and their many 

working groups have dedicated their time to meeting an average of once every other day for 

the past three years. We make each Committee's meetings publicly available through live 

webcasts. These Committees have informed the development and implementation of all of 

HITECH initiatives. 

Progress on HITECH Implementation 

Our goal is to assist clinicians and hospitals in using technology to meaningfully deliver 

health care that is higher quality, safer, patient-centered, and coordinated. And, we want 

providers to thrive in the new health care marketplace that puts a premium on value over 

volume, on coordination over fragmentation, and on patient-centered ness over all. 

The CMS Medicare and Medicaid EHR Incentive Programs, the ONC-Ied certification 

program for electronic health records, as well as the hands-on technical assistance provided by 

the Regional Extension Centers (RECs) across the country, are critical in facilitating 

unprecedented progress in EHR development, adoption and use. There are over 1,700 unique 

certified products produced by nearly a thousand developers, and certified by one of five 

ONC-accredited private sector certification bodies. As of February 2013, more than 230,000 

providers -- nearly 43 percent of the nation's eligible professionals, and over 75 percent of 

eligible hospitals -- have earned over $12.6 billion in total payments for meeting the 

requirements of the EHR Incentive Programs. ONe's Regional Extension Centers (RECs) have 

5 
28 


80807.015

signed up more than 130,000 primary care providers in over 30,000 different practices. This 

means that roughly 44% of the nation's primary care providers have committed to 

meaningfully using EHRs by partnering with their local REC. RECs have signed up more than 

20,000 Nurse Practitioners (NPs), 48% of all NPs nationwide, to assist them in meaningfully 

using EHRs. More than 80% of all Federally Qualified Health Center grantees are enrolled 

with an REC. 

Health IT Patient Safety Action and Surveillance Plan 

The Institute of Medicine's (10M's) 1999 landmark report To Err is Human raised 

awareness of the large number of avoidable medical errors harming patients. The report 

also stated that the use of information technology could improve patient safety through 

automated order entry, clinical reminders, and drug drug interaction and drug allergy 

checking. While the magnitude of establishing a national infrastructure was hard to imagine 

in 1999, the Medicare and Medicaid EHR Incentive Program is a realization of that goal. 

Health IT - which includes EHRs and health information exchange - has already demonstrated 

the ability to reduce medical errors. For example, EHRs can flag and help providers avoid 

potential drug-drug interactions and improve the accuracy of physicians' drug ordering. Yet 

health IT will only fulfill its enormous potential to improve patient safety if the risks 

associated with its use are identified, if there is a coordinated effort to mitigate those risks, 

and if it is actually used to make care safer. 

Recognizing the need to understand how health IT can promote patient safety as well 

6 
29 


80807.016

as identify and mitigate risks, ONC commissioned an 10M study to determine how 

government and the private sector working collaboratively can maximize the safety of health 

IT-assisted care. The 10M report, Health IT and Patient Safety: Building Safer Systems for 

Better Care, was published in November 201l. 

The 10M Report included the following three key findings: 

Health IT can improve patient safety in some areas such as medication safety; 

however, there are significant gaps in the literature regarding how health IT 

impacts patient safety overall; 

Safer implementation and use begins with viewing health IT as part of the larger 

sociotechnical system; 

All stakeholders need to work together to improve patient safety. 

Based on these findings, the 10M recommended that the market forces are not 

adequately addressing the potential risks associated with the use of health IT and all 

stakeholders must coordinate efforts to identify and understand patient safety associated 

with health IT. 

Building on 10M's recommendations, ONC worked collaboratively with colleagues 

throughout HHS to develop the Health IT Patient Safety Action and Surveillance Plan, the 

draft of which was released on December 21,2012. This Health IT Safety Plan addresses the 

role of health IT within HHS' commitment to patient safety. The plan seeks to build upon 

and strengthen patient safety efforts across government programs and in the private sectorincluding efforts by patients, health care providers, technology companies, and health care 

7 
30 


80807.017

oversight bodies - to improve knowledge on health IT-related patient safety events. 

The draft plan prescribes actions that all stakeholders can take within their existing 

authorities and resources to promote a culture of safety related to health IT. Suggested 

actions include: 

• Use ONC-Authorized Testing and Certification Bodies to collect complaints and 

conduct surveillance; 

• Work with developers to establish a code of conduct that includes working with 

Patient Safety Organizations and supporting providers in reporting adverse events; 

• Work with Patient Safety Organizations according to the Agency for Healthcare 

Research and Quality's (AHRQ's) Common Formats in order to improve aggregation 

and analysis of reported events; 

• Include safety requirements related to user-centered design, quality management 

systems, and easier reporting of adverse events in ONC regulations; 

• Work with CMS to train surveyors and use health IT to assist investigations; 

ONC received public comments on the draft plan through February 4, 2013, and those 

comments have been generally favorable. We are in the process of reviewing comments 

and will publish the final Health IT Safety Plan in the near future. 

8 
31 


80807.018

Consumers - The Most Underutilized Resource in Healthcare 

Over the past few decades, we have seen information technology improve the 

consumer experience in almost every other aspect of our lives, including the way we manage 

our finances, shop, and book travel. But, health care has been slower to leverage this 

technology. Most notably, relevant information is not available to patients when and where it 

is needed. 

Increasingly, people are literally taking their health into their own hands-whether that 

means tracking their health through a Smartphone app or a remote monitor, participating in 

online patient or caregiver communities, or accessing their medical records online. Changes in 

consumer technology, such as the growth of mobile phones, are helping to drive this change --

nearly nine out of ten people own a mobile device and nearly half of all Americans own a 

smartphone.2 Mobile devices offers several advantages over traditional PCs-they can help 

remove traditional barriers such as geography and time, breaking down the digital divide in 

underserved communities, enabling remote treatment, and more continuous monitoring of 

health make health more convenient and personalized. The mobile devices in our pocket can 

help us access a world of information at the right time to help make the right health decisions, 

which is important since 80% of Internet users have gone online seeking health information. 3 

Apps like iTriage can help us find a local care facility and Pillbox can help us quickly identify 

unlabeled medications. iBlueButton - developed pursuant to an HHS-sponsored challenge 

'Pew: http://pewinternet.org/Reports/2012/Cell-lnternet-Use-2012/Main-Findings/Cell-Internet-Use.aspx 

3 Pew: http://www ,pewinternet,org/Reports/20 11/Hea Ith T cpics,aspx). 

9 
32 


80807.019

program - can help us share our medical history, and Ginger.io tracks our level of activity. The 

Department of Defense has developed apps to help veterans and their caregivers cope with 

post-traumatic stress disorder. Mobile phones can be an incredible tool for empowering 

consumers to take control of their health, their care, and their health care finances and as we 

know from the literature, more engaged consumers get better outcomes. 

ONe's strategy in consumer eHealth is to work with partners to increase patients' ability 

to access their own health data, to increase the use of this data for actionable apps and 

services, and to shift attitudes around patient empowerment. 

ONe is also encouraging institutions that have health data to make it easier for patients 

to get easy, electronic access to their data and to use that information in ways that improve 

their health and health care. The Blue Button Pledge Program is a voluntary mechanism for 

supporting consumers' access to their health data. The Blue Button Pledge Program now 

includes more than 450 organizations that are committed to learning and collaborating in 

efforts to increase patient access to, and use of, health data. The Pledge Program, launched in 

2011, includes "data holders"-such as health care providers and insurers-who pledge to 

improve the accessibility of health data to patients and other authorized users, and "non-data 

holders" -such as software developers and consumer advocacy organizations- who pledge to 

educate consumers about the value of getting and using their health data. 

The government is moving forward in this direction. Veterans today can access their 

full records online, and download their records with a simple click of a "Blue Button" - and more 

than one million veterans have done so. Medicare beneficiaries can access their full Medicare 

records online today, and download three years of claims data. HH5 is also encouraging 

10 
33 


80807.020

Medicare Advantage plans to expand the use of Blue Button to provide beneficiaries with 

one-click secure access to their health information. And the Federal Employee Health Benefits 

program has asked carriers to do the same. 

Our regulations and guidance are also encouraging this "data liberation" to patients and 

consumers. Our partners in HHS's Office for Civil Rights (OCR) recently launched a campaign to 

build public awareness of individuals' legal right under the Health Insurance Portability and 

Accountability Act of 1996 Privacy Rule to access their own health information - including an 

electronic form - if the information is readily producible in the form. In May 2012, OCR 

released a memo detailing these rights and directing consumers to educational resources. 

Meaningful Use Stage 2, as part of the Medicare and Medicaid EHR Incentives Programs, 

requires eligible providers to use secure e-mail with patients and to provide patients with a way 

to view, download, and transmit their own health information. Under Stage 2, patients will be 

able not only to view their health information online, but also to export their data from EHRs in 

structured and human-readable formats; share those data with others; and use tools and 

applications to store, analyze, or otherwise make use of their information. Stage 2 also 

establishes thresholds for the proportion of patients using these functions, which will 

encourage providers to promote their use. 

11 
34 


80807.021

Privacy and Security of Mobile Technology (including Mobile Applications) 

At ONC, we recognize that clinicians want to use mobile technology to access and 

transmit health information in health care delivery. We recognize the mobile device benefits 

- portability, size, and convenience in overall care coordination. 

However, we recognize that there are risks as well as benefits to any technology. The use of 

mobile health technology holds great promise in improving health and health care. But the 

ubiquity and connectedness of mobile devices creates concerns for privacy and security. ONC 

has developed a number of projects that address the privacy and security of mobile health 

(mHealth) devices, including convening stakeholders and focus groups to identify concerns and 

developing technical assistance and education materials to begin to address those concerns. 

First, ONC is working with other agencies and stakeholders to identify security issues 

with regard to mHealth technology, including smartphones, implantable medical devices, and 

remote monitoring devices. As part of this assessment, ONC hosted the public Mobile Device 

Roundtable in March 2012 where we gathered public, industry, health care provider, and 

subject matter expert input on the topiC of safeguarding health information when using mobile 

technology.4 The Roundtable included participants from various federal bodies that have a 

role in mobile health, including the Food and Drug Administration (FDA), the Federal 

Communications Commission (FCC), FTC, and OCR, to discuss the current privacy and security 

4 For more information about the Mobile Device Roundtable, please visit: 

http://www.healthit.gov!policy-researchers-implementers!mobile:devices-roundtable-safeguarding-health-inform 

ation 

12 
35 


80807.022

legal framework for mobile devices accessing, storing, and transmitting health information. In 

addition, through its mHealth Privacy and Security Consumer Research Initiative, ONC identified 

and explored consumer attitudes and preferences, including underserved populations and 

different age categories, regarding the privacy and security of communicating health 

information using mobile devices, including the use of mobile apps. 5 The research initiative 

highlights the important role that technology developers can play in meeting consumer needs 

for functionality and improving privacy and security. Results from the initiative may help 

inform future policy and educational development activities. 

Second, based on these assessments, ONC has developed technical assistance materials 

on privacy and security involving mobile technology. For example, in December 2012, ONC 

and OCR rolled out a national, multi-prong privacy and security educational initiative targeted 

at health care providers and professionals using mobile devices such as laptops, tablets, and 

smart phones in the delivery of care.6 We developed a set of online tools that encourage 

health care providers and professionals to know the risks and take the steps to protect and 

secure health information when using mobile devices. These materials are available at 

https://www.healthIT.gov!mobiledevices. Although the materials were developed with 

health care providers in mind, anyone can use the education materials to help them securely 

adopt and harness the power of these technologies. 

Through these projects, ONC has been able to rapidly assess and respond to the growing 

6 A variety of resources, including videos, fact sheets, and other downloadable resources, addressing the privacy 

and security protections and safeguards can be found here: http://www.healthit.gov/mobiledevices 

13 
36 


80807.023

need for privacy and security policy and guidelines in securing health information as it is being 

stored and transmitted through mobile technology. 

Model Personal Health Record Privacy Notice 

As personal health information increasingly becomes stored managed by companies 

that offer direct-to-consumer technologies, it becomes important for consumers to be aware of 

these companies' data practices, and to have an easy way to compare the data practices of two 

or more companies. 

The Personal Health Record (PHR) Model Privacy Notice is designed to be a 

standardized template that a web-based PHR company can use to succinctly inform consumers 

about its privacy and security policies7

• The PHR Model Notice was developed by ONC based 

on consumer testing that identified key issues individuals care about and language that they 

understand. The PHR Model Privacy Form is meant to be similar to other consumer-oriented 

"labels" that have been developed for other industries, such as the nutrition facts label for food, 

and the Model Privacy Notice developed for the financial services industry for compliance with 

the Gramm-leach Bliley Act. It is intended to focus only on some important information and 

does not substitute for more comprehensive privacy policies. Many of the largest PHR 

companies have agreed to use the PHR Privacy Model Notice. ONC does not enforce use of 

the tool. However, if a PHR company under the jurisdiction of the Federal Trade Commission 

7 http://www.healthit.gov/policy-researchers-implementers!personal-health-record-phr-model-privacy-notice 

14 
37 


80807.024

(FTC) does not adhere to the privacy and security commitments stated in their PHR Notice, the 

FTC has the authority to challenge the notices as false or misleading in violation of the Federal 

Trade Commission Act. 8 

FDASIA Workgroup on Risk-Based Regulatory Framework for Health IT 

Throughout the development of the Health IT Patient Safety Action and Surveillance Plan, 

ONC worked collaboratively with other federal agencies such as the Agency for Healthcare 

Research and Quality (AHRQ), CMS, FDA, and FCC to leverage existing authorities and to add a 

focus on health IT and patient safety. On February 20, ONC, FDA, and FCC announced the 

formation of the Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup -

under ONe's Health IT Policy Committee -- to provide expert for the development of a 

Congressionally-mandated report on an appropriate, risk-based regulatory framework 

pertaining to health IT, including mobile medical applications, that promotes innovation, 

protects patient safety, and avoids regulatory duplication.9 FDASIA indicated that if a 

8 For a more complete explanation of how the voluntary adoption of privacy and security practices can result in 

legally enforceable commitments, see The White House, Consumer Data Privacy in a Networked World: A 

Framework for Protecting Privacy and Promoting Innovation in a Global Digital Economy, Feb. 2012, available at 

http://www.whitehouse.gov/sites!default!files!privacy-final.pdf. In addition, the National Telecommunications 

and Information Administration is convening stakeholders to develop a code of conduct to improve transparency 

in how mobile applications collect, store, and use personal data. See 

https://www.ntia.doc.gov!other-publication!2013!privacy-multistakehalder-process-mobile-application-transpare 

L!fY. 

9 Section 618 of the 2012 FDASIA charges the Secretary of Health and Human Services (the Secretary) (acting 

through the Commissioner of the Food and Drug Administration (i.e., FDA), in consultation with the National 

Coordinator for Health Information Technology (i.e., ONe) and the Chairman of the Federal Communications 

Commission (i.e., FCC) to publish a report by January 2014 that expresses "a proposed strategy and 

15 
38 


80807.025

workgroup was formed, it should be geographically diverse and include representatives of 

patients, consumers, health care providers, startup companies, health plans or other 

third-party payers, venture capital investors, information technology vendors, health 

information technology vendors, small businesses, purchasers, employers, and other 

stakeholders with relevant experience. The three agencies received applications through 

March 8th to participate in the Workgroup and are now in the process of reviewing the 

nominations. The first meeting of the workgroup is expected to be held in April 2013. 

The FDASIA Workgroup will build on prior work such as the 10M report, Health IT and Patient 

Safety: Building Safer Systems for Better Care and ONe's Health IT Patient Safety Action and 

Surveillance Plan; FDA's mobile medical applications guidance10 and Medical Device Data 

Systems Rule11 ; FCC's National Broadband plan and other relevant work. Specifically the three 

agencies will seek input on issues relevant to the report: 

Types of risk that may be posed by health IT which impact patient safety, the likelihood 

that these risks will be realized, and the impact of these considerations on a risk-based 

approach; 

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." 

10 FDA's proposed oversight approach would limit FDA oversight of mobile medical apps to the small subset that 

are either used as an accessory to a regulated medical device, or that transform a mobile platform into a regulated 

medical device. 

11 This is a down classification rule (Class I) that does not require premarket submissions for medical products that 

are intended to be used in diagnosing, curing treating of a disease and that transfer, store, convert formats, and 

display medical device data. 

16 
39 


80807.026

• Factors or approaches that could be included in a risk-based regulatory approach for 

health IT to promote innovation and protect patient safety; and 

• Approaches to avoid duplicative or overlapping regulatory requirements. 

Like all ONC FACA Workgroups, all FDASIA Workgroup meetings and documents discussed at 

the meetings will be publicly available and will offer opportunities for public comments. 

Conclusion 

New technologies including health IT and mobile applications - offer great promise to 

improve the quality of care and bring down health care costs. Our progress in moving towards 

these goals has been steady and deliberate. Working within an open and transparent process 

with our public and private stakeholders, we have developed a health IT patient safety and 

surveillance report. 

We have worked with other government agencies to help secure the privacy of mobile 

applications, within existing authorities whenever possible. As technologies continue to 

advance, we want to work together with Congress to ensure health data is secure. 

To truly transform delivery, health care providers must also redesign and reengineer 

workflow of care. This does not happen overnight. Health IT holds tremendous promise for 

delivering "smart health" to patients right at their fingertips to help all of us achieve the best 

possible outcome for each individual. We must carefully balance the need for the widest 

innovation possible, with protection of patient privacy, security, and safety. 

17 
40 


80807.027

We look forward to continuing to working with Congress to accomplish these goals. 

would be happy to answer any questions that you may have regarding my testimony. 

18 
41 

Mr. BURGESS. I thank the gentleman for his testimony. 

Before we start members’ questioning, I do want to stress the importance of the members’ questions and the importance of getting 

direct answers from all of you all. The importance of this questioning is reflected in the fact that the Committee recently changed 

rules to limit member opening statements to provide more time for 

testimony and questioning. In order to make the question-and-answer period as productive as possible, I ask that you answer the 

questions in as a director manner as possible. Some members will 

ask yes-or-no questions and I ask that you limit yourself to a yesor-no answer. I thank you in advance for your understanding. 

I will now yield myself 5 minutes for the purposes of questions. 

Ms. DEGETTE. That is not part of the rules. 

Mr. BUTTERFIELD. Will the chairman allow a question at this 

point? Is that part of our committee rules? 

Mr. BURGESS. Stop the clock. 

Mr. BUTTERFIELD. Yes. 

Mr. BURGESS. Yes, the committee rules as adopted and the Committee was to limit the opening statements. 

Mr. BUTTERFIELD. Dr. Burgess—— 

Ms. DEGETTE. Yes, but not the whole rest of the stuff you said. 

Mr. BUTTERFIELD. Dr. Burgess, I have been in this Congress for 

81⁄2 years—not as long as you have—but I have never, ever, ever 

heard of a rule such as that. 

Ms. DEGETTE. It is not a rule. 

Mr. BUTTERFIELD. Thank you. 

Mr. BURGESS. Well, let me direct it as a courtesy then to the 

members of the committee that we keep our answers direct and to 

the questions at hand. 

I yield myself 5 minutes for questions. 

Now, we are here today of course to discuss the issue of the guidance that was produced in July of 2011. Ms. Foreman, the FDA 

proposed its mobile medical apps policy would not regulate the sale 

of the general consumer or the use of smartphones or tablets. And 

certainly, today, we thank you for the certainty. Will the Final 

Guidance definitively say that the sale or general consumer use of 

smartphones or tablets will not be regulated by the Food and Drug 

Administration? 

Ms. FOREMAN. No, it is not the Agency’s intent to change that 

position in the Final Guidance. 

Mr. BURGESS. But, as everything, there is that possibility. And 

that is where the uncertainty comes from. And really, one of the 

things that the last 2 days and today are all about is trying to provide some certainty for the people who work into this space and are 

making significant investments of dollars and time, and they are 

doing so because they think they have ideas that are ultimately 

going to help people. And we would like to provide them that certainty. I think that is one of the reasons these committee hearings 

have been so important. 

Some of the uncertainty we have heard this week relates to the 

fact that the Guidance issued in July of 2011 is a draft. When can 

we look for the final draft, the Final Guidance? When can that be 

released? 

42 

Ms. FOREMAN. We have prioritized that Guidance for publication 

this year. It should be coming soon with the intent of providing 

clarity to the—— 

Mr. BURGESS. Is your microphone working? 

Ms. FOREMAN. It is on. 

Mr. BURGESS. OK. Pull it a little closer then. 

Ms. FOREMAN. We intend to finalize that Guidance this year. It 

is a priority for the Agency. It should be coming out within the 

next few months. And the point of the Final Guidance will be to 

seek to provide clarity by addressing the questions received during 

the comment period, and provide additional examples to clarify the 

Agency’s policy. 

Mr. BURGESS. Did you say it will be coming out in the final 

month of this year? 

Ms. FOREMAN. No, it will be coming out in the coming months. 

Mr. BURGESS. In the coming months. And when you say this 

year, you are talking about the calendar year and not the fiscal 

year? 

Ms. FOREMAN. It should be out before the end of the fiscal year, 

yes. 

Mr. BURGESS. OK. The fiscal year. Well, then let’s make a note 

of that. 

Some of the statements made by the FDA either in the Guidance 

or were made by you today, is the Guidance going to be binding 

on the Food and Drug Administration? Are there situations where 

the Food and Drug Administration has deviated from its Guidance 

when exercising its enforcement discretion? 

Ms. FOREMAN. Guidance is not binding. Guidance represents 

agency thinking, but it is not a regulation. It is not statute. It is 

on a lower level that represents agency thinking to provide clarity 

both to staff and to industry. 

Mr. BURGESS. And again, I do want to just for the record thank 

you for your rapid response to that letter. Again, I do hope that 

sets a new standard for the Administration in replying to letters 

from this committee. Historically, it can take some time to get 

questions answered, but these are important questions. These are 

questions not asked in a partisan manner in any way, shape, or 

form, and really trying to advance the science of the knowledge. 

Dr. Mostashari, I will tell you, again, I do get to travel to a lot 

of places in the country. I talked to a lot of provider groups. And 

I will just say there is some concern. You know, the FDA always 

looks to whether things are safe and effective, well, with the exception of tobacco, but always looks to whether things are safe and effective under its regulatory jurisdiction. I can’t recall if we ever 

saw the randomized clinical trials for electronic health records. Are 

those trials in existence? Were they done? Do we have that data? 

Dr. MOSTASHARI. Dr. Burgess, thank you for your question. 

There are many, many studies that have looked at whether when 

you try to improve quality, whether having information helps. And 

it is not something that perhaps is well-suited to a randomized 

trial at the policy level, but the overwhelming evidence—and we 

have commissioned a study of—that looks at every published study 

on this—and while some of the negative studies, the ones that are 

counterintuitive, get a lot of press, the preponderance of the eviVerDate Nov 24 2008 14:46 Jun 19, 2013 Jkt 037690 PO 00000 Frm 00048 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-22 CHRIS
43 

dence is absolutely that when implemented appropriately, health 

IT is going to improve quality, safety, and efficiency. 

Mr. BURGESS. And yet, I just noticed from your testimony—I 

mean it was the end of last year, December of 2012, when your 

safety guidelines were published. Our stimulus bill was passed 4 

years ago. The implementation began June of 2011 as I recall, and 

December of 2012 is when you were providing the safety guidelines. And you have stipulated such things as privacy and patient 

protections. 

Dr. MOSTASHARI. We have been—you know, our belief is that— 

and I think the evidence is that the best thing we can do for safety 

in general is to get off of paper. And the evidence around computerized order entry, for example, reducing medication errors by 48 percent, is clear. And we have seen an increase in e-prescribing that 

gets away from my handwriting and perhaps yours, which is a good 

thing in terms of improving the safety of prescribing. 

We just heard from the Premier System just this week about how they have saved $9 billion and 91,000 lives by implementing datadriven processes to improve care that can’t be done in a paperbased world. So we believe that really getting healthcare into the 

data age is critical for improving safety. 

Now, as I mentioned, any technology—— 

Mr. BURGESS. Sir, I am actually going to stop you because my 

time has expired. In the interest of getting everyone heard, I will 

yield to the ranking member of the subcommittee. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

I just have a few questions. Over the last 2 days of hearings before today there was a lot of testimony and claims that app developers face a threat from the FDA and that the Agency is planning 

to regulate mobile phones on a wide range of apps and then impose 

a medical device tax on phones. In the chairman’s opening statement, I think he implied that he understands that the Agency is 

not planning to put the medical device tax on phones, but I just 

want to clarify exactly what the Agency is planning to do, Ms. 

Foreman. So I want to ask you a couple questions. 

Is it within the Agency’s jurisdiction to regulate mobile medical 

apps? 

Ms. FOREMAN. Yes, it is. 

Ms. DEGETTE. If you can pull that microphone even closer, I 

think you are a very soft-spoken person. Can you give us some examples of the types of apps that the FDA is trying to regulate? 

Ms. FOREMAN. The apps that we are trying to regulate and that 

we have been regulating for a decade, are similar to what is regulated through other medical device technology, such as a central 

monitoring station for a nurse that transmits patient data, heart 

rate, SpO2, other critical parameters for patient care that need to 

be monitored. We have seen ultrasound technology where there is 

an app and a transducer that can plug into a smartphone to allow 

ultrasounds to take place. Those are the types of technology that 

we are regulating. 

Ms. DEGETTE. And why are you trying to regulate those types of 

technology, Ms. Foreman? 

Ms. FOREMAN. Those types of technology pose patient risk. If the 

device does not perform as intended, there is a potential for patient 

44 

risk. Additionally, it is the same as other medical devices we regulate. We regulate based on intended use, not based on platform. 

Just because a device moves to a mobile platform, it would not be 

the Agency’s intention that that would make it deregulated. 

Ms. DEGETTE. So you are not looking at how the app is used; you 

are looking at what the purpose is, right? 

Ms. FOREMAN. Exactly. 

Ms. DEGETTE. And this is an ability that the Agency has had for 

some years; it is just not new under the Affordable Care Act or 

under the stimulus, correct? 

Ms. FOREMAN. That is correct. Our first clearance of a mobile app 

product goes back to 1997. 

Ms. DEGETTE. 1997, oK. And can you tell me what types of apps 

the Agency will not be regulating and why? 

Ms. FOREMAN. There are apps that do not meet the definition of 

a medical device. The Agency would not regulate those. Those 

would be, for example, an app that takes an electronic version of 

a printed textbook. We have said that is not a medical device. 

Ms. DEGETTE. OK. 

Ms. FOREMAN. There are mobile medical devices that meets the 

definition of a device, but the risk is low. The Agency would rather 

focus its regulatory priorities on the higher-risk products. So devices for maintaining a healthy lifestyle that help with—— 

Ms. DEGETTE. Pedometers—— 

Ms. FOREMAN. Exactly. We would not put regulatory oversight 

priorities into those products. 

Ms. DEGETTE. OK. Now, in a different subcommittee the other 

day, members of the industry also agreed with what you are saying. Qualcomm’s representative testified at that hearing ‘‘the FDA 

is squarely within its jurisdiction and we took a lot of their initial 

actions as a very promising indication to the industry at large that 

they were willing to work with all of us.’’ So Ms. Foreman, I want 

to ask you, what are you doing to make sure that the Agency 

doesn’t overreach when regulating these devices and using the 

standards that you have set forth? 

Ms. FOREMAN. As I mentioned, for FDA to regulate the product, 

it must first meet the definition of a medical device. That is what 

gives the Agency its authority. But for all of the products that technically meet the definition of a medical device, we have narrowed 

our focus to a smaller subset of those based on risk. We are actually refining our regulatory approach rather than overreaching. 

Ms. DEGETTE. OK. So that is good that you are narrowing it 

down, looking at things that affect patient safety and so on, but we 

are still hearing concerns about the impact of uncertainty on the 

mobile medical device market. Can you tell me what the Agency is 

doing to eliminate this uncertainty for investors and developers? 

Ms. FOREMAN. We believe finalizing the mobile medical apps 

Guidance is the first step in eliminating that uncertainty. That 

Guidance will provide clear, transparent, and predictable messaging regarding FDA oversight of mobile medical apps. 

Ms. DEGETTE. And that is the Guidance that you told Mr. Burgess that you are planning to issue by the end of the fiscal year, 

right? 

Ms. FOREMAN. Correct. 

45 

Ms. DEGETTE. Now, also, we have heard concerns about the effects of FDA-induced delays on the mobile medical device market. 

Now, how do you respond to those? 

Ms. FOREMAN. We looked at our performance over the last 3 

years, which we believe is a contemporary sample of performance. 

On average, it takes the FDA 67 days to review a mobile medical 

app. That is well within our statutory time frame of 90 days for 

the 510(k) process. All mobile apps we have seen thus far have 

been in the 510(k) process on—— 

Ms. DEGETTE. And you are going to continue that—— 

Ms. FOREMAN. For the most part, yes. 

Ms. DEGETTE. Thank you. Mr. Chairman, I had referenced the 

letter from the FDA in my opening statement and asked for inclusion in the record, and the chairman said he had received it but 

I don’t believe he agreed to my unanimous consent request to put 

it into the record, so I would renew that request. 

Mr. BURGESS. I also received it and I accept your unanimous consent request. So ordered. 

[The information appears at the conclusion of the hearing.] 

Ms. DEGETTE. Thank you so much. 

Mr. BURGESS. The chair recognizes Mr. Johnson from Ohio, 5 

minutes, for the purposes of questions, sir. 

Mr. JOHNSON. Thanks to our panelists for coming today. 

The Meaningful Use Program has made good progress in automating the current system. The first stage was to encourage adoption of current technology and gain automation efficiencies. Of 

course, Stage 2 addressed connectivity and sharing of information, 

and Stage 3, the final stage, is where providers and patients have 

accurate, real-time information in the systems and devices that 

provide care anywhere. 

As an IT professional myself for nearly 30 years, architecture 

and a roadmap of where you are going is vitally important because, 

as they say, if you don’t know where you are going, any road will 

get you there. And you can pump millions, billions into these 

projects. And in today’s environment, our healthcare providers simply don’t have millions and billions to pump into something that 

is not working for them. 

So what is the gap between today’s technology and the architecture of tomorrow to achieve an integrated, coordinated care system? How are we making sure that the data that is being collected 

people can use? I call it decisional information. How are we making 

sure that we are connecting the dots? 

Dr. MOSTASHARI. That is a terrific question and you are absolutely right that it is the use of data not just the data itself that 

improves care. And as we found in other IT endeavors, it—particularly—IT becomes particularly important when you redesign the 

processes to take advantage of the information technology instead 

of merely digitizing the paper-based or former processes. 

Mr. JOHNSON. And I would certainly agree with you. You know, 

over my 30 years in IT, one of the cardinal lessons is just because 

something can be automated doesn’t mean that it should be automated. It is an issue of business process reengineering, and if you 

don’t do that, you don’t have a complete solution or certainly you 

don’t have a solution that is connected. 

46 

So who is developing the architecture that tells our healthcare 

providers in our system how this is all going to fit together? 

Dr. MOSTASHARI. We have developed that roadmap that you 

speak of, and it is an incremental roadmap, as you mentioned, 

through the stages. And it begins with making sure that we have 

data because until you have data, you really can’t see what you are 

doing. You can’t have accountable care if you can’t count. And that 

is where paper-based systems are today. So in Stage 1, the idea is 

let’s collect the information in a structured way because—yes. 

Mr. JOHNSON. Well, that goes back to what I said earlier, and I 

think this is a discussion between two IT professionals here that 

everybody else may get bored with. That goes back to the ‘‘if you 

don’t know where you are going, any road will get you there.’’ I 

don’t think you know what data you need until you have an architecture and you know what the end stage looks like. You know, in 

the many, many software and technology programs that I managed 

throughout my 30-year career, if you don’t start with an idea of 

what the end state looks like, then you waste a lot of money; you 

waste a lot of time. 

Dr. MOSTASHARI. That is right. 

Mr. JOHNSON. So I am not sure data collection up front without 

knowing what data you want to collect makes a whole lot of sense. 

Dr. MOSTASHARI. Let me clarify my response. 

Mr. JOHNSON. Sure. Because we start with data. Data doesn’t become information until it is relevant and until it can be used. And 

data just for the sake of data, as you know, is—— 

Dr. MOSTASHARI. That is right. 

Mr. JOHNSON. So go ahead. I am sorry. 

Dr. MOSTASHARI. Sorry about that. So we start with—in the 

framework, we actually start with the end in mind. So we said 

what is it about the use of technology that can—we can expect to 

improve safety, improve the quality of care, patient engagement, 

public health. And then we work backwards to say, oK, if we want 

to reduce deaths—unnecessary deaths, those are associated with 

better decision support at the point of care, it is associated with 

quality measurement, and being able to make a list of patients by 

certain criteria, oK, and taking that a step back, you need to be 

able to have a list of medications for patients. That is pretty clear. 

We need to have a list of their problems and diagnoses. You need 

to know their allergies. You need to know their laboratory values. 

You need to know their blood pressure and smoking status. And it 

was those data elements recognizing that as the system evolves, 

there would need to be flexibility and the ability to extend that 

framework and add in the next iteration devices, for example. 

Mr. JOHNSON. Like I said, people are probably going to get bored. 

You and I can—— 

Dr. MOSTASHARI. We would—— 

Mr. JOHNSON. But how many physicians have been involved in 

the development of this roadmap and the kind of data that we need 

to—— 

Dr. MOSTASHARI. We have one of the, I think, hardest-working 

and most respected Federal Advisory Committees in government. 

We—it—there—it is—there are certain statutory representations 

on that. The house majority and minority leaders appoint members 

47 

to the Policy Committee. The Senate minority, majority leaders, 

the Comptroller General—— 

Mr. JOHNSON. My time is expired. 

Dr. MOSTASHARI. Sorry. 

Mr. JOHNSON. The chairman is making that known, so I thank 

you for your answers. I would love to talk to you more sometime. 

Mr. BURGESS. And the gentleman may request the answer in 

writing, and I hope that he will. 

The chair recognizes—— 

Dr. MOSTASHARI. Will do. 

Mr. BURGESS [continuing]. Now Mr. Waxman, the ranking member of the full committee. 

Mr. WAXMAN. Thank you, Mr. Chairman. 

Ms. Foreman, we have heard a lot of allegations over the last few 

days that FDA is intending to regulate everything and anything 

digital or online that has any relation to healthcare. But the facts 

seem to be very different. I know you have attempted in your testimony, as well as in the 2011 Draft Guidance, to allay concerns 

about the scope of what FDA intends to regulate. But I would like 

for the record to go over some of the examples we heard in testimony yesterday or the day before. Is FDA currently proposing or 

does it intend in the future to regulate ordinary smartphones and 

tablets? 

Ms. FOREMAN. No, it does not. 

Mr. WAXMAN. What about mobile platforms in general such as 

the iPhone, Blackberry, Android phones, tablet computers, or other 

computers that are typically used as smartphones or personal digital assistants? 

Ms. FOREMAN. No. 

Mr. WAXMAN. What about the entire mobile network? 

Ms. FOREMAN. No. 

Mr. WAXMAN. Each new mobile device released on the market? 

Ms. FOREMAN. No. 

Mr. WAXMAN. All health IT? 

Ms. FOREMAN. No. 

Mr. WAXMAN. An iPad application to help track the number of 

steps walked per day? 

Ms. FOREMAN. No. 

Mr. WAXMAN. An iPad application that reminds one that it is 

time to refill a prescription? 

Ms. FOREMAN. No. 

Mr. WAXMAN. Software that enables a physician to search a medical textbook? 

Ms. FOREMAN. No. 

Mr. WAXMAN. Apps to allow parents to access online services 

such as personal health records to document procedures that a 

baby has undergone and drugs their baby was given? 

Ms. FOREMAN. No. 

Mr. WAXMAN. I don’t think you can be any clearer. FDA has established limits on what it can and cannot regulate in the mobile 

device market, and I appreciate you walking through these limits. 

While I know that IRS, not FDA, implements the tax code, I 

would like to ask you a bit about the recent claims that mobile 

platforms will be taxed under the Medical Device Act. Under the 

48 

new medical device tax, will smartphones and iPads now be taxed 

as medical devices? 

Ms. FOREMAN. The FDA is a public health agency, not a taxation 

agency. 

Mr. WAXMAN. I understand. 

Ms. FOREMAN. These questions would probably be best answered 

by IRS or the Treasury, but my understanding is no. 

Mr. WAXMAN. These type of products are exempt from the medical device tax, isn’t that correct? Can you explain a little bit about 

this exemption? 

Ms. FOREMAN. As I said, we are public health agency—— 

Mr. WAXMAN. Yes. 

Ms. FOREMAN [continuing]. Not a taxation agency, but they 

would not be regulated as medical devices, therefore, not subject to 

the medical device tax. 

Mr. WAXMAN. OK. As I understand it, they will be exempt because FDA will not define them as a medical device, and even if 

you did define them as a medical device, they won’t be tax because 

they will qualify for the retail exemption. The law says that items 

sold to consumers by way of retail cannot be taxed. Isn’t that your 

understanding as well? 

Ms. FOREMAN. That is my understanding. 

Mr. WAXMAN. Although we don’t rely on you for tax information. 

Ms. FOREMAN. You really should not. 

Mr. WAXMAN. But we are interested in this issue because it has 

been brought up so many times, and this committee is not a committee that has jurisdiction over tax. 

I thank you very much. It is clear that fears that iPhones and 

other smartphones are going to be regulated by FDA and taxed as 

medical devices are unfounded and we can put this myth to rest. 

OK. Well, Mr. Chairman, my staff informs me the next question 

is not for me to pursue and I have asked the questions that I think 

are important and I think they are good way to end the third day 

of hearings to allay a lot of the fears that have been raised in the 

other two. And so unless anybody wants my minute, I will yield it 

back. 

Mr. BURGESS. And the chair thanks the ranking member. It is 

forever in his debt. 

Now yields for 5 minutes to Ms. Ellmers from North Carolina. 

Mrs. ELLMERS. Thank you, Mr. Chairman. 

Thank you. Thank you. And Dr. Mostashari, good to see you 

again. We have worked together many times on this issue and 

there again thank you for coming. Thank both of you for coming 

to testify today. 

You know, one of the things—and I know we have discussed this 

in the past—is really the cost to physicians who are small business 

owners, and as important as we all know health information technology is, the cost being passed on to them, you know, there are 

estimations of 15,000 to $70,000 for the cost of implementing IT. 

And also, there is the issue of the physician really being taken 

away from the patient at the bedside to implement the information. 

And there is of course that learning curve that everyone has to go 

under. 

49 

Now, one of the points that is being made is how this is helping 

eliminate errors and actually thereby improving healthcare. However, when limited time is given to the patient directly, hands-on, 

and eye-to-eye contact with that patient, don’t you think that subsequently it could actually have a bearing on the ultimate outcome 

of the patient, maybe something being missed, possibly tests being 

over-ordered as a result of not an adequate time with the patient? 

Dr. MOSTASHARI. Overall, the—we actually have data from the 

National Center for Health Statistics where providers report that 

EHRs have, in their estimation, produced clinical benefit for their 

patients. It is 79 percent. And if you look at those who are using 

the modern systems and who have been using it for more than 2 

years—and this is important because it takes time—— 

Mrs. ELLMERS. Yes. Yes. Sure. Sure. 

Dr. MOSTASHARI [continuing]. To get used to the systems, that 

rises to 92 percent. Now, providers believe that in their practice the 

electronic health records are providing clinical benefit to their patients. 

Mrs. ELLMERS. OK. Now, that leads me to my next question because a lot of the software is incompatible with other facilities, so 

software that one physician may be using may not be the same 

software another physician or the physician in the hospital not 

using the same. So getting back to again considering errors, considering the possibility of information not being exchanged adequately, but also considering cost, which of course ultimately gets 

passed on to the patient, and we are always looking for good quality of care, what is going to happen when we are trying to integrate 

all those systems? Is this cost then going to be passed on to the 

physician again and, you know, having to bear the brunt of that 

expense? 

Dr. MOSTASHARI. Making sure that the patient information is 

available when and where it is needed is one of our top priorities. 

And we could have, as some countries have done, have said we are 

going to solve that problem by the government is going to buy the 

EHR system for the whole country. That is not the way we do 

things—— 

Mrs. ELLMERS. Yes. Yes. 

Dr. MOSTASHARI [continuing]. Right? We said the people who are 

best suited to make those purchasing decisions are the hospitals 

and doctors who have to live with the systems. But in order to 

make sure that they can talk with each other, then we need to 

have some standards. We need to have a certification program and 

to evolve that certification program and to create consensus, industry consensus—— 

Mrs. ELLMERS. Yes. 

Dr. MOSTASHARI [continuing]. Private sector consensus around 

how we can have one doctor choosing one system, the other choosing a different system that meets their needs but having those systems—— 

Mrs. ELLMERS. Be able to communicate. 

Dr. MOSTASHARI [continuing]. Be able to talk to each other. That 

is the approach we have taken, and the certification criteria for 

2014 put a big step up in those requirements. 

Mrs. ELLMERS. OK. Thank you. 

50 

Ms. Foreman, I do have a couple questions. I know we continuously are talking about, one, the FDA regulation issue, which is 

very important, but also the tax on the medical devices. Has the 

FDA looked at this as an issue that it might actually be stifling 

some of the innovation moving forward with having the tax on 

medical devices? 

Ms. FOREMAN. As I said, we are public health agency. Our decisions are governed by public health. Our decision-making is based 

on balancing innovation and public health. 

Mrs. ELLMERS. Yes. Yes. 

Ms. FOREMAN. We identified a large subset of devices that could 

be under enforcement discretion without our regulatory oversight. 

Mrs. ELLMERS. Yes. Yes. 

Ms. FOREMAN. As it happens, those devices may not be subject 

to the device tax. 

Mrs. ELLMERS. OK. 

Ms. FOREMAN. As was mentioned, there is a retail exemption as 

well—— 

Mrs. ELLMERS. Right. 

Ms. FOREMAN [continuing]. Meaning products available for retail—even declared to be a medical device—is exempt from the 

tax—FDA does is a public health organization, not a taxation agency. 

Mrs. ELLMERS. Thank you. Thank you. My time is expired. 

Thank you both. 

Mr. BURGESS. The chair recognizes the gentleman from North 

Carolina 5 minutes for purposes of questions, sir. 

Mr. BUTTERFIELD. I thank you, Mr. Chairman. 

And I thank both of you for your testimony here today. 

Over the course of the last 2 days of hearings, and actually in 

Ms. Foreman’s testimony here today, we have learned that FDA 

has proposed regulating only a very small subset of mobile applications. FDA’s Draft Guidance states that the Agency will only look 

at those mobile apps that are essentially acting as a medical device 

or as part of one. The Guidance also explicitly exempts many of the 

apps that my colleagues on the other side have been trying to scare 

people into thinking FDA was going to take over, things like electronic PDRs and electronic health records. That seems like a very 

reasonable approach to me. 

But I want to learn more about exactly what kind of regulatory 

burden we are talking about even with this small subset of applications that will be regulated as devices. I know that an FDA-regulated medical device may fall into one of three tiers. We have heard 

about that. Class 1 devices are the least risky devices while Class 

3 devices are the most risky. 

And so let me start with Ms. Foreman. Ms. Foreman, can you 

briefly elaborate on these three levels of device oversight and explain what responsibilities a device manufacturer has under each 

of these levels? 

Ms. FOREMAN. Certainly. I will start at the bottom and work up. 

If the device is a Class 1 device, and this small subset could include devices that would meet the Class 1 definition of a medical 

device, they are not subject to agency premarket review. They are 

subject to meeting registration and listing requirements, as well as 

51 

the quality system regulation, which ensures that the devices are 

manufactured properly. 

Moving up to Class 2 devices, these must meet those same criteria—registration, listing, quality system—but they also need 

what is called a 510(k) or a premarket notification. That application would allow the Agency to review and clear the device as 

equivalent to another device on the market. There is a user fee associated with that. It is just under $5,000. However, if it is a small 

business, it is half of that. If the sponsor makes significant modifications to the device, they would need a new 510(k), but as I mentioned, we planned many of those iterative changes to not require 

new submissions of 510(k)s. 

If we move up to the next level, Class 3, those devices require 

a premarket approval application. To date, we have not found a 

mobile app that would fit into that category. I am not saying that 

in the future it wouldn’t be possible, but we have not seen one yet. 

Mr. BUTTERFIELD. So essentially, what you are saying is that a 

Class 1 or 2 device doesn’t have to do all that much in terms of 

premarket clearance, while Class 3, if there is one, sounds like it 

may be subject to more stringent requirements if one evolves—— 

Ms. FOREMAN. Correct. 

Mr. BUTTERFIELD [continuing]. Is that correct? 

Ms. FOREMAN. Correct. 

Mr. BUTTERFIELD. OK. Now, which level of regulatory oversight 

will most of these medical applications fall under? 

Ms. FOREMAN. Class 1 or Class 2. 

Mr. BUTTERFIELD. Class 1 or Class 2. And you don’t know of any 

Class 3 existing at this moment? 

Ms. FOREMAN. I do not. 

Mr. BUTTERFIELD. All right. Now Ms. Foreman, there were also 

some assertions yesterday that FDA lacked the expertise to regulate mobile applications. Your testimony states that you have regulated medical device software for decades and mobile apps for more 

than 10 years. Can you elaborate on FDA’s experience regulating 

in this area? 

Ms. FOREMAN. Absolutely. This is not a new area for the FDA. 

We have been regulating software and mobile apps for some time. 

When we do our review, we actually bring together two different 

sets of expertise. There is the software expertise, we have software 

engineers who will review the software information to make sure 

that it was developed properly, coupled with a clinical review because the app is intended for a medical application. For example, 

if you take an app to view a radiology image on a smartphone, the 

software reviewer can make sure that all of the technical specifications happen properly on the smartphone. And we will ask the clinical reviewer for an evaluation to determine if, for example, we 

view an image on a smartphone, can we actually detect cancer with 

the same level of sensitivity and specificity that we would on the 

large view station? You can zoom the image, you can pan, you can 

look at it that way, but is there a difference between looking at the 

whole image versus pieces of the image to make sure that patient 

safety is not compromised? Because you don’t want somebody to 

have undergone radiation for a diagnostic purpose and then—realize there is a false negative or a false positive. 

52 

Mr. BUTTERFIELD. Can you finally address how you plan to keep 

up with the world in which so many apps are already on the market and so many new ones are coming out every day? How are you 

going to keep up with all this stuff? 

Ms. FOREMAN. As I mentioned, part of keeping up with it is 

prioritizing our focus, and we are prioritizing our focus on the 

small subset; within that subset we receive about 20 applications 

a year. Right now, we are getting less than 20 a year. That is actually in our 510(k) inventory. That is about .5 percent of the medical 

device applications that we review. And keeping up with technology 

is something that we are always faced with, so that is why we add 

on competent staff and we make sure to provide training opportunities for those staff so that they can continue to stay abreast of 

the latest technology. 

Mr. BUTTERFIELD. Thank you. My time is expired. 

Mr. BURGESS. The gentleman’s time is expired. 

I am advised that votes have been called. We will try to go over 

and get through as many of the panel as we can. 

I recognize the gentleman from Missouri 5 minutes for questions. 

Mr. LONG. Thank you, Mr. Chairman. And thank you all for 

being here today. 

Director Foreman, I have a question for you. As far as current 

FDA Risk Evaluation and Mitigation Strategy, REMS for short, 

their Guidance requires, doesn’t it, that medication guides upon 

first dispensing of the medication and then for every subsequent 

refill you have to have the medication guides printed out. Is that 

correct? 

Ms. FOREMAN. So I am going to apologize because REMS is a 

provision implemented by CDER, or Center for Drug Evaluation 

and Research. So that is really outside of my area of expertise in 

the Center for Devices and Radiological Health. 

Mr. LONG. OK. Who should I go to to answer that question? Who 

should I—— 

Ms. FOREMAN. CDER is headed by Dr. Janet Woodcock. 

Mr. LONG. OK. OK. Because that was my intent was to ask if 

on a refill prescription if that could be able to be handled through 

a mobile device as opposed to trying to mail a stack of how to retake your medicine every time that it is prescribed. So with that— 

and I know we are short on time—Mr. Chairman, I yield back. 

Mr. BURGESS. The gentleman yields back. 

The gentleman from New York is recognized for 5 minutes for 

questions. 

Mr. TONKO. Thank you, Mr. Chair. 

Dr. Mostashari, there is a broad consensus that the increased 

use of electronic health records and health information technology 

ultimately leads to better patient care and a bending of that cost 

curve and savings, but there is also a concern that the adoption of 

these EHRs also provide an increased opportunity for fraud by exaggerating the intensity of care or severity of patients’ conditions 

on their Medicare claims. We have, I guess, labeled this as up-coding and it is often facilitated by software programs that prompt 

billing for additional services that were not provided and maybe 

only tangentially related to the care received. Many of our health 

53 

IT vendors are developing these systems to promote their products 

as a way to increase the bottom line. 

So my question is can you discuss what your office is doing to 

develop guidance and technological standards in electronic health 

records software that will help to prevent this type of fraud? 

Dr. MOSTASHARI. Yes, thank you for the question. I want to make 

one thing very clear, which is that if there is documentation of care 

that did not occur, that is fraud. And CMS and the Attorney General and the Secretary of Health have made it very clear that we 

will not tolerate fraud. And the electronic health records provide 

increased tools also on our side to be able to better investigate and 

prosecute fraud should it occur. There are always those who will 

attempt to defraud the system and I think this Administration in 

particular has been very successful and has had record prosecutions and recoveries under that. 

But I think your question gets to also issues where it is not explicit fraud, and those are more complicated situations. I think 

some of the analysis has been done looked at patterns of coding intensity over the past decade. Before the first meaningful use payment check ever went out, for a decade there has been this creep 

towards higher intensity codes. CMS—this is not a new issue for 

CMS and they have ways of dealing with shifts in these patterns. 

But the electronic health records that were formally predominantly 

used for documentation and billing purposes before meaningful use, 

that may have been part of the business case for them. I think that 

our challenge is twofold. First, to make sure that we get the broadest possible input on ways that we can mitigate any possibility of 

the records systems themselves inducing inadvertent violations. 

The second is to make sure that the systems meet the needs of 

the future, which is, as I think there is broad consensus, means 

moving away from paying fee-for-service based on documentation 

and more towards outcomes and value. 

Mr. TONKO. Thank you. And what lessons can be drawn from the 

implementation of EHRs nationwide from the VA’s long successful 

track record with VISTA, their Veterans Health Information Systems and Technology Architecture program, specifically in terms of 

interoperability and usability of records? 

Dr. MOSTASHARI. It is interesting, following on your previous 

question, one of the groups that had the most experience with the 

perils of copy-and-paste was the VA, which, even though there was 

no billing incentive, it was convenient to carry forward notes from 

before, and it resulted in not—it is not a billing issue. It is a clinical documentation issue where it wasn’t easy to understand. If you 

practiced at the VA, sometimes you saw notes that were copied forward and forward and forward, and it wasn’t good for clinical care. 

You couldn’t understand what was really going on with the patient 

in this visit. And the VA has done a lot working with clinical leadership to say how can we improve the quality of the clinical documentation and the usability of the systems? 

The VA—there is very strong evidence that they have saved billions of dollars by implementing IT and by continually improving 

the systems that they have. And if there is one lesson I would take 

from the VA it is that, that no system is perfect the day it is implemented. And it becomes improved over time through the polishing 

54 

of that stone to the application of clinical judgment, improved 

usability, improved interoperability, and that is what we are engaged with here. This is not a, you know, one-and-done process. 

This is going to be a continual process of refinement, optimization, 

improvement, and redesign. 

Mr. TONKO. Thank you, Dr. Mostashari and Ms. Foreman, for appearing before us. 

And Mr. Chair, with that, I yield back. 

Mr. BURGESS. The gentleman’s time is expired. 

The chair now recognizes Mr. Griffith for 5 minutes for questions, sir. 

Mr. GRIFFITH. Thank you. 

And I apologize to the witnesses in advance. I have to move fairly quickly so I am cutting through a lot of the explanation because 

I think you all know where we are heading with the questions as 

we get to it. But if you need further, let me know. 

Ms. Foreman, your testimony notes that questions about medical 

device tax should be directed to the IRS, but clearly, they are going 

to need help in figuring out what is a medical device at what you 

are regulating as a medical device if it is the purpose of it and not 

the platform. And so I would ask, have you had any discussions 

with the IRS about this tax, if they have asked for your input on 

that? 

Ms. FOREMAN. We provided technical input to the IRS on the interpretations of our laws. The way it was implemented is that if 

a medical device lists, it would be subject to the tax. 

Mr. GRIFFITH. And can you provide us with a copy of what you 

gave the IRS so we can take a look at that to the committee? Not 

today, but subsequently? 

Ms. FOREMAN. I can look into that. 

Mr. GRIFFITH. OK. Thank you. And has the FDA done any analysis on the impact of the tax either in dollar figures or the number 

of manufacturers it will have an impact on? 

Ms. FOREMAN. FDA is a public health agency. We are not involved in the taxation. We receive no direct benefits. 

Mr. GRIFFITH. In regard to the questions, the list of examples 

that Mr. Waxman listed out, while the FDA does not currently 

have any plans, do you believe that the FDA could if it so chose 

to do so regulate those examples down the road if it had a change 

of heart? 

Ms. FOREMAN. If the device meets the definition of a device as 

defined in the Food, Drug, and Cosmetic Act, we could. We have 

no intent to. The only thing that would change our mind is if there 

was a strong safety signal that we became aware of related to a 

device that we were not regulating appropriately under enforcement discretion. By not regulating it, that would cause us to reconsider our position. But absent strong safety signals, no, we would 

not change our mind. 

Mr. GRIFFITH. All right. And then the practical question that I 

would have is if somebody is currently developing an app of a medical nature, how does anybody know if they are supposed to be contacting the FDA? And, you know, I am just an old country lawyer 

and I got on my tablet here—it is an Android—and found an article 

yesterday and there was lots of; I just chose this one because it 

55 

sounded interesting—that the iPhone is now a handy tool for detecting and diagnosing parasites, and the article says ‘‘using little 

more than an iPhone, strips of double-sided tape, a cheap ball lens, 

and a battery-powered flashlight, a workable model was assembly 

to determine whether or not a child had parasites.’’ Are you all regulating that or not? 

Ms. FOREMAN. To my knowledge, we have not regulated that. It 

has not come before us. A diagnostic device, though, would meet 

the definition. That would—— 

Mr. GRIFFITH. So if the Canadians, the Bostonians, and the 

Swiss who worked this up to help in other countries decided that 

it might be helpful in rural parts of the United States, they would 

have to come to you first, and instead of costing $8, it would cost 

what? Hundreds of thousands? 

Ms. FOREMAN. We are not involved in the pricing of medical devices. 

Mr. GRIFFITH. No, no, no, I am not talking about with the price 

is. I am talking about how much it costs to get it approved. 

Ms. FOREMAN. So, as I say, a 510(k) fee is just under $5,000. If 

it is a small business, it would be half of that. 

Mr. GRIFFITH. OK. 

Ms. FOREMAN. So $2,500. 

Mr. GRIFFITH. But you would want all kinds of tests and studies, 

not the fact that they have been out in the field and made it work 

with double-sided tape, am I not correct? 

Ms. FOREMAN. I am not inherently opposed to double-sided tape 

but—— 

Mr. GRIFFITH. I understand. I think I have made my point, and 

I yield back my time, Mr. Chairman. 

Mr. BURGESS. I thank the chair. The chair yields to the gentleman from Texas, Mr. Barton, for questions. 

Mr. BARTON. Mr. Chairman, I appreciate the time. I want to 

yield it to you to use as you so decide. 

Mr. BURGESS. Well, I thank the chairman emeritus. 

Dr. Mostashari, I just have to ask you here as we conclude today, 

I hear a lot of stuff about interoperability. I mean you are the 

head. Why don’t you just fix that? Why don’t you just make that 

happen? 

Dr. MOSTASHARI. We are using every lever at our disposal to increase the sharing of information, and that includes not just the 

data standards and getting industry together to help us. We don’t 

want to be the ones to say, you know, we will choose the standards. 

We really want to work with industry to get consensus and to accelerate this. 

Mr. BURGESS. But, you know, in the interest of time, we do hear 

about this a lot. Even anecdotally, hospital systems in the same 

city that have the same operating system aren’t talking to each 

other. It seems like you could make that happen. 

Dr. MOSTASHARI. We—the 2014 certification criteria, Dr. Burgess, I—we—I would be happy to go into great detail with you, but 

they are a big step forward, and I believe that hospitals and doctors around the country will see a palpable difference once those 

certification criteria are in place. 

56 

Mr. BURGESS. Well, I want to thank both of our witnesses for 

being here today and for bearing with us. I apologize about votes 

cutting the hearing short. Dr. Mostashari, I look forward to having 

you back at either the Health Subcommittee or this subcommittee 

in the future. You are a fascinating witness. We have learned a lot 

this morning from both of you, and I appreciate your time. 

I want to thank the members for their devotion to the hearing 

today. 

The committee rules provide that members have 10 days to submit additional questions for the record to the witnesses. I also 

failed to ask for unanimous consent that all members’ statements 

that wish to be entered in the record be entered. 

Hearing no objection, so ordered. 

The hearing stands adjourned. 

[Whereupon, at 10:25 a.m., the subcommittee was adjourned.] 

[Material submitted for inclusion in the record follows:] 

57 


80807.028

The Honorable Tim Murphy 

Chairman 

Subcommittee on Oversight and Investigations 

Committee on Energy and Commerce 

House of Representatives 

Washington, D.C. 20515-6115 

Dear Mr. Chairman: 

20993 

Thank you for your letter of March 1,2013, cosib'1led by six of your colleagues, regarding the 

requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Patient 

Protection and Affordable Care Act (PPACA), and how these laws are applied to the 

mannfacturers of smartphones, tablets, and individualized applications (apps). Your letter poses 

several specific questions concerning the activities of the Food and Drug Administration (FDA 

or the Agency) regarding the regulation of "ire less medical devices (also referred to as "mobile 

medical applications" or "mobile medical apI's"). 

We have restated your questions below in bold, followed by FDA's responses. 

1. When will the FDA issue final or updated guidance with respect to the July 19,2011, 

request for input on its oversight approach for mobile medical applications designed for 

use on smar!phones or other mobile computing devices? 

FDA issued a draft guidance domment regarding mobile medical applications on July 21, 

2011.' That guidance announced FDA's intention to exercise enforcement discretion for 

most mobile apps. The draft guidance proposed regulatory oversight of only a small subset 

of mobile apI's (referred to in the guidancc as "mobile medical apps') that meet the definition 

ofa device in section 201 (h) ofthe FD&C Aet and are intended for use as either: (1) an 

accessory to a regulated medica~ de\'ice, or (2) to transfom1 a mobile platform ioto a 

regulated medical device. 

and Food and Drug Administration Staff - Mobile Medical 
58 


80807.029

Page 2 - The Honorable Tim Murphy 

FDA received more than 130 submissions to the public docket on the draft guidance. Many 

cornmenters sought additional clarity on the types of mobile apps for which FDA intends to 

exercise enforcement discretion. FDA will seek to provide this clarity in the final guidance. 

Commenters ovenvhelmingly supported the narrowly tailored approach FDA described in the 

draft guidance. FDA has since received many more inquiries from members of industry 

eager to see the guidance finalized. The mobile medical apps guidance is currently in the 

final stages of Agency review. The Agency has previously indicated its intent to publish the 

final guidance this year. 

2. Has the FDA discussed, prepared, or analyzed the effect of the medical device tax on 

smartphones (as well as tablets or similar devices) or the creators or distributors of 

applications for those products? If so, please provide all documents analyzing or 

relating to this issue. 

FDA has not analyzed the effect of the medical device tax on creators and distributors of 

smartphones, tablets, and similar devices but is aware of concerns about the effect on 

innovation if novel technologies become subject to the tax. FDA developed the Agency' S 

draft mobile medical apps policy to protect public health and promote innovation, 

Although the definition of a "taxable medical device" is tied to the FD&C Act, it is the 

Internal Revenue Service (IRS) and the Department of the Treasury that are responsible for 

the excise tax imposed on the sale of certain medical devices, not FDA. Moreover, as 

indicated by the IRS's definition of "taxable medical device," not all medical devices 

regulated by the FD&C Act are subject to the ta'{-{)nly those that are required to list with 

FDA. Because the mobile medical app draft guidance states that the Agency intends to 

exercise enforcement discrction for many mobile apps v,1th respect to applicable device 

requirements, including listing, FDA does not expect those devices to list. 

Questions about the implementation of this policy should be directed to the IRS. 

3. Will the actual use of a smartphone, tablet, or app be a factor in whether the FDA 

chooses to regulate the device or app as a medical device? Has it been a factor in any 

analysis by FDA already completed? 

The answer to both questions is no. 

As stated in FDA's draft mobile medical apps guidance, FDA's mobile medical apps policy 

will not regulate the sale or general consumer use of smartphoncs, or tablets even when such 

sale or use is in a health care setting (e.g., in a doctor's ofilce or hospital). FDA's proposed 

mobile medical apps policy does not consider entities that exclusively distribute mobile 

medical apps, such as the owners and operators of "iTunes store" and" Android market," to 

be medical dcvice manufacturers. 

Instead, FDA's draft mobile medical apps guidance toeuses on the intended use ofthe mobile 

app and proposes oversight only for those mobile apps that meet the definition of a "device" 
59 


80807.030

Page 3 The Honorable Tim Murphy 

under section 201 (h) ofthe FD&C Act, and are either intended for use as an accessory to a 

regulated medical device or to transform a mobile platform into a regulated medical device. 

This analysis is typieal of how FDA has handled various products that might be devices that 

serve multiple purposes. FDA looks to the intended use of the product to determine whether 

the product is a device. The intended use of a product is typically detennined by how a 

product is marketed; that is, by labeling, advertising, and promotional claims. 

We note that products that are not intended for use in the diagnosis of a disease Of other 

conditions, or in the cure, mitigation, treatment, or of disease, including 

smartphones, tablets, and apps, even when used in a health care setting, would not be 

considered to be medical devices. 

4. How many mobile medical apps have sought approval from the FDA before entering 

the market? What was the processing time for each ofthese apps? How many mobile 

medical apps have been sub.jecf to oversight by the FDA after introduction to the 

market? How many apps have either been changed or removed from the market by 

FDA oversight, and why? 

It is imponant to note that FDA has been regulating medical deviee software for decades and 

medical device software on mobile platfonns for more than 10 years. During the past 10 

years, the Agency has revievv'ed more than 30,000 premarket medical device submissions, 

including approximately 100 for mobile medical apps. However, FDA traditionally has not 

categorized or tracked premarket submissions based on the specific underlying technology of 

a medical device. Rather, our systems have been focused on capturing devices that generally 

fall within device classifications that are grouped by medical specialties (for example, 

radiology; ear, nose, and throat; toxicology; dental; ophthalmic; etc.). We are currently 

exploring methods to better capture the number and types of mobile medical app 

submissions. 

For 2011 and 2012, the average time for FDA review of medical device submissions that 

were identilied as containing a mobile medical app was 67 days and the average total time 

from submission to FDA decision was 110 days, These numbers represent review of not 

only the mobile medical app, but also review of any relevant attachments or accessories 

included in the submission. For example, review of a submission of a glucose meter 

included evaluation of both the mobile medical app and the blood glucose attachment. 

In general, manufacturers often voluntarily correct their products that either be in 

violation of the FD&C Act or experience a malflll1Clion that could result serious injury or 

death. We are aware of one voluntary recall invohing a mobile medical app that could 

miscalculate an insulin dose potentially resulting in dangerously low or high blood glucose 

levels in diabetic patients. In addition, the app was unintentionally made available in the 

United States by the manufacturer. The mannfacturer voluntarily notified all users 

worldwide and removed the app from the Global App Store. 
60 


80807.031

Page 4 The Honorable Tim Murphy 

As requested in your letter, appropriate FDA representatives briefed staff of the COllUuittee 

on Energy and Commerce and discussed these issues by telephone conference on Thursday, 

March 14, 2013. 

Thank you, again, for contacting us concerning this matter. lfwe can be offnrther assistance, 

please let us know. The same Jetter has been sent to your cosigners. 

Sincerely, 

Michele Mital 

Acting Associate Commissioner 

for Legislation 

cc; The Honorable Henry A. Waxman, Ranking Member 

The Honorable Diana DeGette, Ranking Member 

Subcommittee on Oversight and Investigations 
61 


80807.032

Thc Ilonorable Tim Murph~ 

Chairman 

Subcommittee on Ovcrsight and Investigations 

Committee on Energy and Commerce 

I,jouse of Represent;iives 

\Vashington. D,C. 20515-6115 

Dear ML Chairman: 

MAY 02013 

Thank you for providing the opportunity tl>r the Food and Drug Administration (FDA or the 

Agency) to testify at the March 2 L 20! 3. hearing before the Subcommittee on Oversight 

and Investigations. Committee on Energy and Commerce. entitled "'lleallh Information 

Tcchnologies: Administration Pcrspectives on Innovation and Regulation." This letter 

provides responses for the record to questions posed by certain MCl'nbers of the 

Subcommittee. which \\c received on April 9, 2Dl2, 

If you have thrthe,. questions, please let us know. 

Sincerely. 

Michele IVlital 

Acting Associate Commissioner 

for Legislation 

tc: The Honorable Diana DeGette 

Ranking Member 

Subcommittl;:'e on and In\'e~tigations 

Commerce 
62 


80807.033

Page 2 - The llonorable Tim Murphy 

We have restated each Member's questions below in bold. lb!lowed by OUf responses. 

1. The slates that the FDA's proposed 

mobile medical ap!> to mobile apps that perform the 

fUllctiionalilty of an eiectronie health (EHR) system or health record 

system. Has the FDA iUIl! discussions or conducted on how this 

will to the insurance that debut on li, 

2014 as part oftbe Patient Protection and Care Act? Will any mobile 

lIPpS related to the be to this Same statement? 

fDA's proposed policy would focus its regulatory oversight on only a subset of mobile 

medical apps that meet the definition ofa device in section 20l{h) ofthe Federal Food. 

Drug, and Cosmetic Aet (FD&C Act) and are intended to be used as an accessory to a 

cleared/approvcd medical device, or to tnmsibrm a mobile platfoml into a clcared/approved 

medical device. We are not awarc of any mobile apps related to health insurance exchanges 

under the Patient Protection and Ailbrdable Care Act that meet that definition, 

2. your indicated that FDA had provided technical guidance to 

the ~nternal Revem.le to the Medical Device Tax created the 

Patient Protection and Affordable Act. Please dds for the 

\Vc are in receipt oflhe April 9. 2()13, tener to FDA on this issue from Chainnan Fred 

Upton, House Committee on Energy and Commerce, Chairman Tim Murphy, Subcommittee 

on Ovcrsight and and Rep. Morgan Griffith. We will respond to this request 

under separate cover. 

3. Both written and responses to questions at the indicated 

that willl.lltilize its discretiun in a mobile 

medical apE> will be regulated more carefully (and subject to the 

Mcdie<.d Devi£e Tax). Are there in wbich that discretion wm not be 

necessary? If a previous or furore indicates that manufacturers 

should automatically with the or otherwise notify the FDA srilleil' 

intentions, could that trigger increased Will the use enforcement 

discretion occur on a case case basis· or win there be certain that 

guarantee a mobile requires in£reascd oversight, outside of the 

listed in tbe guidance? 

FIJA's draft guidance. issued in July 2011. proposes our intent to exercise enforcement 

discretion tlJr most mobile apps. As stated in our guidance. FDA is !bcusing. its regulatory 

priorities on those mobile apps that mect the definition of device and are intended to (1) bc 

used as an accessory to a cleared/approved medical device. 01' (2) transform a mobile 

platform into a clcared/approved medical device. FDA typically makes its enforcement 
63 


80807.034

Page 3 - The Honorable Tim Murphy 

decisions on a case-by-ease basis and these decisions will be 

forth in the final version of this >!U!U<HIU;. 

by the principles set 

To help darify tile Agency's policy for mobile medical apI's, FDA intcnds to post on its 

website new examples of mobile apps on which FDA is focusing its priorities, 

l. With the tbollsands of medical apI's that are cu .... ~'nltllv 

does FDA have to approve the majority of these 

developed, wbat plan 

apps in a timely fashion'? 

FDA has been reviewing medical device software for almost as long as FDA has had 

premarket review authority for devices, Further, although there are thousands of mobile 

apps on the market, relatively Jew have required FDA review. FDA has reviewed 

approximately 100 mobile medical apI'S over the last decade. All of these apI's have been 

reviewed as premarket notit1eation (5iO(k» submissions. rather than premarket approval 

applications (PMA). 

Even with the recent increased growth and availability ofthese mobile apI's, in the last two 

years FDA has received for clearance no more than 20 premarket notification (51 O(k» 

submissions per year for mobile medical apI's. For 2011 and 2012, the average time for 

FDA review of medical device submissions that were identified as containing a mobile 

medical app was 67 days. Under the FD&C Act. medical device 51 O(k) clearances are to be 

completed within 90 days. and our data show that the Agency is well \vithil1 that time franle 

in reviewing mobile medical app submissions. 

FDA docs not anticipate a substantial increase in its premarket review workload due to an 

increased number of submissions tl)r mobile medical apI's. Under FDA's propos<.'<i 

guidance, most mobile apI's will fall outside of FDA's regulatory focus. Thc approach 

propcsed in the Agency's July 2011 draft guidance on mobile medica! apI's states that 

FDA's oversight will focus on a small subset of mobile apI's that arc similar to medical 

devices that are clearedlapproved or that may affect the functionality ofdearedfapprovcd 

medical devices. 

2. Has FDA considered a 3-tiered, risk-bastd framework for bealth 

informatioll medical appli, as discussed McKesson in 

testin!!lEllY before tile and Commerce Health Subcommittee on Wcdnesday, 

March 2013 and by the Bipartislln Center in a February 2013 stlldy titled 

"An Oversight Framework for Assuring Patient Safety in HIe'.hith Information 

Technology"'? 

As required by section 618 of the Food and Drug Administration Safety and Innovation Act 

(FDASIA),! FDA is working with the Federal Communications Commission (FCC) and the 

Department of Health and Human Services (HHS) Office of the National Coordinator for 

I Public Law 112,144, 126 Stat. 9n (July 9, 2012). 
64 


80807.035

Page 4 - The Honorable Tim 

Health Infol1nation Technology (ONe) to develop a report a proposed strategy 

and recommendations on an risk-based regu!altlry framework pertaining to 

health information technology that promotes innovation. protects patient and avoids 

regulatory duplication. 

The three agencies are a workgroup of exlemal stakeholders and experts, as 

suggested in section 618 under the of Health and Iluman Services 

Health Information Technology (HIT) Policy Committee. This wi!! allo\\" for diverse 

stakeholder groups to input to the HIT Policy Committee on the proposed strategy 

and recommendations the risk-based regulatory framework for health information 

technology. The working group will be with providing input on a tiered, risk-based 

regulatory framework that appropriately addresses patient safety and innovation and avoids 

regulatory duplication. We intend to consider all proposals, including the 

approaches that were described in the testimonies before the Health Subcommittee of the 

House Committee on Energy and Commerce during the ? ... 1arch 20, 2013, hearing entitled 

"Health Intormation How Innovation Benefits Patients." 

3. If so, does the FDA need to facilitate the , ... ,,,,,~,,,'~ adl~ptilln and 

Im'l)!emE!ntlttnm of a 3-tiercd, risk-based fill' health 

, .. r" ... " .. t'"'' tell:lnnOiogy, including medical 

Please sec response to Question #2 above. 

1. The world we live in is filled with resourees for everyday folks to their 

symptoms by adviee websites, and countless m!:UtcIIIIHI'«m!.'leu 

llppS. I am a proponcllt of consumcrs direct access to information, but 

do you have any Cllncerns about il!ldividuals using these to and 

not their doctor or other healtheare you talk 

moment about the impact these medical apps Illn'c bad on eonsumer actions'! 

Certain health-related mobile apps can improve the care and quality of life for many people, 

giving them tbe freedom to conveniently access health-related infonnation that can help 

them make important decisions about their care. Mobile apps that motivate Individuals to 

lead a healthy lifestyle (tor example. by and eating a healthy diet) providing 

information and education are good examples mobile technology has enhanced 

people's lives and helped them manage their conditions. We cncourage consumers of these 

types of apps to consult their physicians and other health care professionals before making 

any lifestyle changes that could potentially affect medical conditions. 

For other types of mobile apps that are to help individuals diagnose illnesses, there 

is always the risk that consumers \lIouId not seek treatment when they should. We believe 

that consumers should make informed decisions and so instead of solely relying on 
65 


80807.036

Page 5 - The llanorable Tim Murphy 

technology to diagnose a disease or health-related condition. they should also consult a 

licenscd medical practitioner, as ar>!JrGIPri'lIe. 

1\10bile medical apps that allow consumers to a disease must be shown to be 

sate and effective so that consumers can rely on them as they would rely on a blood glucose 

meter or an over-the-counter blood pressure cuff, 

FDA intends to focus its oversight on these types of mobile medical apps. to 

ensure that this technology. which enables consumers and patients to diagnose serious 

diseases or conditions or that may be used to make important treatment decisions. is safe and 

effective. 

2. mobile wheIDI their creators or conSUmers 

notice problems that reqllire correction. will tile FDA with new 

gcnerations of web and help ensure COIDI§UmCl"S IIlfC safe and 

accurate mobile 

FDA's proposed mobile medical apps policy would not mobile medical 

developers to scek re-evaluation tor minor, product ehangcs that not 

significantly affect and effectiveness of the mobile app. Even for the small subset 

of mobile medical applications that FDA would actively regulate, such changes could be 

made without notification to FDA, provided that the manufacturer complies with applicable 

Quality System requirements in making such 

For changes that significantly afTect and effectiveness of the mobile medica! app, 

FDA would take a risk-based approach that primarily relies on manufacturers to have 

Quality System processes in place. Significant changes made to higher-risk regulated 

mobile medical apps may be subject to certain additional oversight by FDA, in order to 

ensure that such changes do not adversely affect the saiety and effectiveness of the device. 

3, Certain mobile appUcatiorms nr01tICII':iv with ail m"",ru,£" ... ",,,mobile 

device. How Cllin we llissist in COlllUlllUllticati,ng are 

"",,,, .. ,,,,,.,,,1" .. for their indi"'idual mobile 

The mobile apps industry plays an important role in standards in areas such as 

device compatibility. Some industry groups have already begun activities in developing 

open architectures and standards with rcgard to expectations tor compatibility, FDA can 

also playa role, by participating with health care industry, and standardsetting organizations in standard-setting activities. 
66 


80807.037

QUESTIONS FOR THE RECORD: Farzad Mostashari, National Coordinator for Health Information 

Technology, U.S. Department of Health and Human Services 

"Health Information Technologies: Administration Perspective on Innovation and Regulation" - March 

21,2013 

Committee on Energy and Commerce, Subcommittee on Oversight and Investigation, U.S. House of 

Representatives 

Chairman Murphy 

Question 1: 

Page 7 of your testimony notes that a November 2011 10M report reported that "market forces are 

not adequately addressing the potential risks associated with the use of health IT." Has ONC 

experienced this? Does ONC believe that market forces are not adequately addressing patient safety 

or other risks? 

ONC believes that on the whole, the adoption of health iT has greatly improved patient safety by 

reducing medical errors and helping to standardize the way that care is provided, but we are mindful of 

the need to ensure that new systems are built and used in the safest possible manner. We believe 

market forces have already motivated a high level of safety in the industry, but there is opportunity for 

improvement. For instance, in 2014, certified EHR technology developers will be required to publicly 

identify a method of incorporating user-centered design that has a high likelihood of helping to prevent 

medical errors. Certified EHR technology developers will also be required to provide transparency 

regarding their approach to quality management systems. 

In our draft Health IT Patient Safety Action and Surveillance Plan, we encouraged the industry to draft 

and enforce a voluntary code of conduct to improve safety practices, among other things. We will 

continue to monitor the industry's progress in addressing potential safety risks going forward. 

Question 2: 

Page 8 of your testimony notes that ONC's draft plan on Health IT Patient Safety will recommend the 

inclusion of "safety requirements related to user-centered design ... and easier reporting of adverse 

events ... n Can you elaborate on the authority given ONC to either compel or recommend that these 

items be included? How will this be enforced, if ONe chooses to endorse this approach? 

The draft Health IT Patient Safety Action and Surveillance Plan (the Safety Plan) restates ONe's 

commitment to patient safety through the safe use of health IT. Prior to the Safety Plan's release, ONC 

had already adopted through rulemaking two safety-related 2014 Edition certification criteria for EHR 

technology. The first certification criterion requires that EHR technology presented for certification to 

anyone of eight specific medication-related capabilities must have had user-centered design processes 

applied to them in order to be certified. The second certification criterion requires the identification of 

the quality management system followed and used in the design of the EHR technology. Given that 

these requirements are part of ONe's HIT Certification Program, they will be primarily enforced by the 

certification bodies ONC has authorized to perform certifications and, generally, by ONC in providing its 

overall program oversight. 
67 


80807.038

Question 3: 

One of the main concerns about the push for the meaningful use of health IT is that we may be 

encouraging doctors and patients to rely more heavily on computers or the internet than face-to-face 

interaction. Do you have any evidence that the use of health IT is better or worse than interaction 

between a doctor and patient? Have any studies been done on the possibility this could decrease 

patient safety? 

Meaningful Use does not replace appropriate physician-patient interaction or in any way encourage 

virtual interaction when face-to-face is best warranted. Its application encourages more productive 

interactions by enabling physicians to make more fully informed pOint-of-care decisions and 

recommendations. Just as the advent of the telephone did not preclude, prevent, or disable the need for 

face-to-face interaction between the patient and his/her doctor, health IT and Meaningful Use provides 

yet another timely conduit for information exchange. 

One of the most recently published reports by David Radley, et. aI., describes how the use of 

computerized provider order entry (CPOE), a central component of Meaningful Use, decreases the 

likelihood of prescribing error by 48%1 ONC believes the application of this tool has tremendous 

potential to improve patient safety. 

Question 4: 

Many complaints have been made about the problem of interoperability - health IT systems that 

cannot communicate with each other - in fact you were asked about this during questioning. What 

does ONe plan to do to finally solve this problem? 

Health IT and the secure exchange of information across providers are crucial to reforming the system. 

In 2014 EHRs will be significantly more interoperable because providers will have to demonstrate that 

they can exchange clinical information with other providers. 

More specifically, starting in 2014 hospitals, doctors, and other eligible professionals that use certified 

EHR technology in Stage 2 of Meaningful Use will be able to share summary records across providers, 

send electronic prescriptions, electronically report clinical quality measures, and allow patients to view, 

transmit and download their health information. These advances, combined with the ongoing work ONC 

is doing to develop standards for health information exchange, will continue to drive increasing levels of 

interoperability over the coming months and years. 

In addition, we are currently considering which policy levers might be able to strengthen the business 

case for the exchange of health information by making sure that different providers and vendors have 

the strongest possible incentive to share information. In March, ONC and eMS jointly issued a request 

for information (RFI) seeking public input on this issue. We have received over 200 comment letters 

from a wide variety of stakeholders, which we are reviewing. 

I Radley, D. C., Wasserman. M. R .. Olsho. L. E. W .. Shoemaker S. J, Spranca. M.D., Bradshaw, B. Reduction in 

medication errors in hospitals due 10 adoption ,!lCOmpuleri=ed pro)'ider order enfly systems. JAm Med Inform 

Assoc 470-476 Published Online First: 20 February 2013 doi:lO.1136/amiajnl·2012-001241 (available at 

lillJ.li,williilml.i.&ill.ll!£Q1l!l::!llL:;QihllflJQi:!£.) (last accessed 4/15/20 13) 
68 


80807.039

We are also encouraged that others have increasingly recognized the progress that is underway. At a 

recent hearing on HIT standards and interoperability that took place on November 14th, 2012 before the 

House Committee on Science, Space, and Technology, Subcommittee on Technology, all five witnesses 

stated that progress is being made on interoperability. Similarly, in an October, 2012 report on 

information sharing, the Bipartisan Policy Committee stated that a business case for electronic health 

information sharing is beginning to emerge, and also that the Meaningful Use Stage 2 requirements that 

take effect in 2014 largely address a majority of the information sharing needs that have been identified 

in clinician surveys. 

Question 5: 

Does ONe see a problem with information sharing among psychologists or behavior health workers? 

Were Health IT incentives offered to this group? Why or why not? 

ONC has worked with the HHS Substance Abuse and Mental Health Services Administration (SAMHSA) to 

clarify the federal protections over substance abuse information in the context of health information 

exchange.' These efforts led to the publication of FAQs "Applying the Substance Abuse Confidentiality 

Regulations to Health Information Exchange (HIE). Further, in September 2012, in partnership with other 

components of the Department of Health and Human Services (HHS) and with the Department of 

Veterans Affairs (VA), ONe, through its Data Segmentation for Privacy Initiative (DS4P) demonstrated 

that with proper standards in place, existing privacy laws and poliCies can be implemented appropriately 

in an electronic environment. Using standards identified in the DS4P Initiative, SAMHSA and the VA 

safely and securely transmitted a mock patient's substance abuse treatment records tagged with privacy 

metadata from one EHR to a different EHR system after electronically verifying that the mock patient 

had consented to the transmission. 

Health IT incentives were not offered specifically to psychologists or behavioral health workers, and only 

mental health professionals who meet the definition of an eligible professional (EP) could qualify to 

receive EHR incentive payments under Medicare or Medicaid. The specific criteria for Medicare or 

Medicaid EPs can be found at the following link: http://www.cms.gov!Regulations-andGuidance/Legislation!EHRlncentivePrograms!Getting Started.h.J:ml. 

Question 6: 

The Health Insurance Portability and Accountability Act (HIPAA) protects the privacy of an individual's 

health information. How does ONC balance the requirements of HIPAA with the benefits of Health IT? 

What conflicts or barriers exist? In particular, are there any specific barriers or problems related to 

mental health records that ONe has encountered? Has ONe done any analysis or identified any 

problems related to HIPAA and the coming health insurance exchanges established by the Patient 

Protection and Affordable Care Act? 

ONC recognizes the importance of protecting the privacy of patient health information while at the 

same time encouraging greater use of health information technology (Health IT) in order to achieve 

significant improvements in areas such as health care quality and cost control. ONC works closely with 

other Health IT stakeholders to create a culture where ensuring the confidentiality, integrity and 

availability of electronic health information is seen less as a barrier to health information exchange than 

as a valued, shared cultural norm. 

2 htlp:llwww.samhsa.gov/aboutilaws/SAMHSA_ 42CFRPART2F AQll_ Revised.pdf 
69 


80807.040

With respect to HIPAA, ONC is not aware of any specific problems related to mental health records and 

the use of Health IT. For the most part, the HIPAA Privacy Rule treats mental health records in the same 

manner as any other protected health information {PHI}. Under the Rule, a health care provider 

generally may use and disclose protected health information, including mental health records, for the 

key health-care related purposes of treatment, payment, and health care operations without obtaining 

the patient's express written authorization. While the Rule generally does require patient authorization 

for a covered health care provider to disclose psychotherapy notes (Le., notes recorded by a mental 

health professional documenting the contents of a private or group counseling session which are 

maintained separately from the rest of the medical record), such notes are subjective to and for use by 

the originating provider and thus, access to the notes is rarely needed by other health care entities for 

treatment or other purposes. 

Finally, with respect to the coming health insurance exchanges, ONC reviewed and contributed to the 

Patient Protection and Affordable Care Act (ACA) regulations, to help ensure that privacy, security, and 

data stewardship policies were appropriately incorporated into the final rules governing the new modes 

for exchanging and analyzing health information under the ACA. This effort addressed regulations 

governing: 1) accountable care organizations; 2) qualified entities that provide performance 

measurement services, 3) and the health insurance marketplace. 

Representative Johnson 

Question 1: 

As an IT professional for 30 years, I understand the vital importance of IT architecture and having a 

road map to achieve the end state. As they say, if you don't know where you are going, any road will 

get you there. 

When ONC and CMS together published the original set of rules setting up the Electronic Health Record 

Incentive Program in 2010, we articulated long-term goals for the program that continue to serve as a 

useful roadmap as the program evolves over time (see 75 FR 44321). We continue to believe that 

certified EHR technology used in a meaningful way is one piece of a broader HIT infrastructure that will 

ultimately help reform the health care system and improve health care quality, efficiency, and patient 

safety. We look forward to working with you as we continue to pursue this vision. 

Question 2: 

With regard to the Meaningful Use Program currently in place to guide implementation of electronic 

health record (EHR) systems, how is HHS ensuring that we aren't just collecting and digitizing data? 

Were the stages of Meaningful Use crafted with an IT architecture in mind that spans all stages to 

achieve a specific end? If so, then how? 

Starting with the first proposed rule on Meaningful Use Stage 1 issued in January 2010, HHS laid out its 

vision for what Stages 1, 2, and 3 would look like and focus on. With that vision in mind, we worked 

backward and charted an ambitious yet incremental course for the industry. We also took care to 

ensure that each Meaningful Use stage would build on the next. Thus, as an eligible provider progresses 

from one stage to the next they are asked to use the data in their EHR technology (and the technology 

itself) in specific ways that will help enhance care delivery and improve patient engagement. As we 

consider policy for Stage 3, we will continue to work toward the vision we laid out with a careful interest 
70 


80807.041

in making sure that the experience eligible providers' gain through Stages 1 and 2 can be applied in 

Stage 3. 

Question 3: 

Information must also be relevant and functional for the end user. How have you involved health care 

providers in the development of this road map to ensure that the time, money, and effort put into 

these systems will be worth their while and create an integrated, coordinated care system that 

streamlines their work? What concerns have these providers had with regards to EHR and Meaningful 

Use stages and how has HHS worked with these individuals to address them? 

Health care providers and other health professionals have been involved at every step of HHS's policy 

development processes for Meaningful Use. The HIT Policy Committee, which has made policy 

recommendations regarding Meaningful Use, includes healthcare providers that participate in the EHR 

Incentive Programs - for instance, the Committee's Meaningful Use Workgroup includes 8 medical 

doctors (including both co-chairs), 2 registered nurses, and a variety of other stakeholders who 

represent the health care industry more broadly. ONC and CMS openly solicit feedback from provider 

organizations during our rulemakings, and HHS employs several staff with significant clinical experience 

working with electronic health records. In both our Stage 1 and Stage 2 rulemaking processes, we 

introduced significant new flexibilities for providers into our final rules in response to public comments. 

Some provider concerns are unique and specific to their practice/setting while others are more general. 

To educate providers about program requirements, HHS has produced a significant amount of 

downloadable education materials, increased the number of webinars and education sessions, and 

regularly communicated with provider associations to help spread the word. We have also devoted a 

considerable amount of resources toward the 62 Regional Extension Centers (RECs) that have been 

established across the country through cooperative agreements funded under the Health Information 

Technology and Clinical Health (HITECH) Act. The personnel that work in the RECs are local experts and 

work hand-in-hand with health care providers along every step of the way - from selecting an EHR to 

getting to meaningful use. We have also established a virtual infrastructure of communities of practice 

to enable healthcare providers to share best practices with each other and to communicate feedback 

directly to HHS. 

Representative Butterfield 

Question 1: 

Many rural parts of my congressional district are desolate and where the nearest primary care doctor 

can be an hour or more drive away. East Carolina University located in my district in Greenville, North 

Carolina has been operating a telemedicine program since 1992 - making it one of the oldest 

telemedicine programs in the world. Recognizing that there is a dear link between access to care and 

improved health, what other resources in addition to telemedicine are available now to link the rural 

elderly and indigent populations to healthcare providers like primary care doctors and physician's 

assistants? What is on the horizon? 

Medicare pays for certain telehealth services to beneficiaries in rural communities. Medicare pays for 

these services when they are furnished at specified originating sites that include physicians' offices, 

critical access hospitals, rural health clinics, and federally qualified health centers, and when those sites 
71 


80807.042

are in either a rural Health Professional Shortage Area (HPSA) or a non-Metropolitan Statistical Area 

county. 

In addition to telehealth, there are a number of programs available to help link the rural elderly and 

indigent populations to health care providers. HHS administers the Rural Health Outreach program, 

which provides grants to rural communities to test out new ideas and develop models for improving 

access to care. This program includes funding for rural health networks that help rural providers work 

together to build better systems of care. 

As authorized under Section 3026 of the Affordable Care Act, HHS is also partnering with community 

based organizations and acute care hospitals under the Community-Based Care Transitions program to 

improve transitions of beneficiaries from the inpatient hospital setting to other care settings, to improve 

quality of care, to reduce readmissions for high risk beneficiaries, and to document measurable savings 

to the Medicare program. One of these partners, Access East Community-based Transitional 

Partnership, is located in Greenville, North Carolina. 

Question 2: 

Recently, Congress passed legislation that requires the Department of Defense to expand 

telemedicine opportunities to service members regardless of whether they are on a base or in a 

home, and regardless of where the doctor is licensed. Are there ways we can use this model in other 

federal programs like Medicare to better expand access to care via telemedicine? 

The Center for Medicare and Medicaid Innovation is testing several projects related to increased use of 

telehealth. A project in Hawaii received a Health Care Innovation Award for telehealth-based home 

monitoring for very high risk patients with complex health care needs in order to prevent 

hospitalizations. A project in Wyoming received a Health Care Innovation Award to improve care 

coordination and communication with practitioners in ten rural Iowa counties using telehealth and webbased personal health records. 

In addition, under the Affordable Care Act, accountable care organizations (ACOs) participating in the 

Medicare Shared Savings Program agree to coordinate care for beneficiaries, such as through the use of 

telehealth, remote patient monitoring, and other such enabling technologies. 

Question 3: 

The VA has moved to mostly eliminate cost sharing on telemedicine, recognizing treating veterans at 

home is less expensive than treating them in a VA facility. For example: The Veterans 

Administration's home telehealth program has resulted in a 30 percent reduction in hospital 

administration and a 20 percent decrease in hospital stays. How can Congress build off this model 

and achieve similar outcomes in other federal healthcare programs? 

The Veterans Administration has long been a pioneer in the use oftelehealth technology. In addition, 

the Health Resources and Services Administration has awarded funding for using tele-home care 

services. The CMS Center for Medicare and Medicaid Innovation (Innovation Center) has also funded a 

number of new models using telehealth technology. The Innovation Center is testing innovative 

payment and service delivery models that have the potential to reduce expenditures while preserving or 

enhancing the quality of care provided to Medicare, Medicaid, and CHIP beneficiaries. Participants in 

the testing of all of the models are encouraged to use health information technology, and we 

understand that they are using a variety of different technologies. 
72 

Æ 


80807.043

Currently, under the fee-for-service Medicare benefit, Medicare has the authority to pay for 

telemedicine services for beneficiaries in specified rural communities provided by specified providers. 

Section 1834(m) of the Social Security Act authorizes Medicare payment for telehealth services. The 

statute requires that the originating site for telehealth services be in an area designated as either a rural 

health professional shortage area, or a county that is not included in a Metropolitan Statistical Area. 

The statute lists certain services that are considered telehealth, but also allows for the addition of other 

telehealth services. CMS annually evaluates whether to add additional services to the telehealth 

benefit, and last year in the final rule for the CY 2013 Physician Fee Schedule, a variety of new services 

were added. Some of these new services include: alcohol and substance abuse and intervention 

services; annual alcohol misuse screening; annual depression screening; intensive behavioral therapy for 

cardiovascular disease; and intensive behavioral therapy for obesity.