[Congressional Record Volume 160, Number 24 (Monday, February 10, 2014)]
[Senate]
[Pages S853-S854]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mrs. FISCHER (for herself, Mr. King, and Mr. Rubio):
  S. 2007. A bill to amend the Federal Food, Drug, and Cosmetic Act to 
provide for regulating clinical and health software, and for other 
purposes; to the Committee on Health, Education, Labor, and Pensions.
  Mrs. FISCHER. Mr. President, I rise today to speak about rapid 
advancements in health care information technology or health IT. Health 
IT holds amazing potential to transform Americans' everyday lives for 
the better. I believe that protecting this kind of exciting innovation 
from overregulation and excessive taxation needs to be a high priority.
  That is why I am introducing the Preventing Regulatory Overreach to 
Enhance Care Technology or the PROTECT Act of 2014. Together with 
Senator Angus King of Maine and Senator Marco Rubio of Florida, we are 
putting forward this pro-jobs, risk-based framework governing health 
IT.
  Before I speak about our bill, I thank my colleague from Maine 
Senator Angus King for joining me in this effort. I am informally 
telling people that our efforts might be the start of the ``surf and 
turf caucus'' in the Senate, the place where Nebraska and Maine come 
together politically to find common ground and work to address real 
problems in this country.
  We are able to do so together because Senator King is known as an 
independent thinker, a problem-solver who isn't afraid to work across 
the aisle in order to get things done. It is refreshing, and I 
sincerely appreciate his willingness to work with me.
  I also give special thanks to Senator Rubio for his interest in this 
issue as well. He is also an original cosponsor, and he has worked with 
us on this important topic.
  What we are trying to do is clarify the Food and Drug 
Administration's oversight authority over health information 
technologies. Under current law dating back to 1976, the FDA can apply 
its definition of a medical device to assert broad regulatory authority 
over a wide array of health IT, including applications that do not pose 
a threat to human safety.
  That means low-risk health IT can be treated like traditional medical 
devices, subjecting job creators and innovators to these challenges 
that really don't make sense.
  The PROTECT Act fixes this discrepancy. The PROTECT Act keeps the 
FDA's resources focused on products that pose the highest risk to human 
health. In doing so it also gives regulatory certainty to innovators 
and job creators who are developing these new products that use data 
safely to improve health care and also to reduce its cost. Furthermore, 
the PROTECT Act relieves categories of low-risk clinical and health 
software from the 2.3-percent medical device tax. Most importantly, 
though, it protects and promotes American jobs in a key growth sector 
of our economy.
  The mobile health and mobile application market is expected to exceed 
$26 billion by 2017, while the U.S. mobile apps economy is responsible 
for nearly half a million new American jobs. A report from Health Data 
Management anticipates 23-percent annual growth in this sector over the 
next 5 years. The FDA highlights on their Web site that 500 million 
smartphone users worldwide will be using health apps by 2015. The 
mobile analytics platform Localytics, which monitors more than 20,000 
apps, has seen a 19-percent increase in new health and fitness apps in 
2013 from the year prior. That is amazing.
  But what is even more impressive is the health IT's ability to 
protect people. Consider the example of a young man named Xavier Jones 
whose basketball coach downloaded a $1.99 mobile application that gave 
him a refresher course on how to properly administer CPR. It was a 
skill that came in handy the very next day when Xavier collapsed in the 
middle of practice.
  In 2012 the Departments of Defense and Veterans Affairs partnered to 
release a free Apple and Android app called the Post-Traumatic Stress 
Disorder Coach. PTSD Coach has been downloaded over 100,000 times in 74 
countries. It provides reliable information on PTSD and treatments on 
users' smartphones.
  Other types of health IT, such as electronic health records and low-
risk clinical decision software, can also lower costs and can improve 
outcomes. Some of these technologies hold the power to quickly and 
broadly disseminate new information about effective

[[Page S854]]

treatments and recent clinical trials. Patients want their doctors to 
have access to these cutting-edge therapies. Protecting low-risk health 
IT is about empowering people with access to information. We need to 
protect that kind of innovation because innovation is an equalizer for 
consumers.
  These technological benefits don't stop at our borders. Think about 
this statistic: One estimate shows that mobile health deployment in 
Africa could save as many as 1 million lives by 2017. From assisting 
nurses with scheduling to reminding pharmacists to refill their stock 
or even tracking emerging malarial epidemics, mobile health is already 
transforming the landscape of the developing world in very dramatic 
ways.
  These stories only scratch the surface of where this technology is 
going. It is important how we treat innovation here in the United 
States. Other countries around the world are looking at how our 
government will regulate and oversee these low-risk technologies.
  Our bill makes it so low-risk, highly innovative clinical and health 
software technologies--and the potential they have to empower people--
are not undercut by these burdensome regulations. FDA's promise to use 
its enforcement discretion over low-risk health IT only serves to 
create confusion and uncertainty in the marketplace. Regulatory 
discretion by its very nature is something that can easily change over 
time, and discretion can be misused or abused.
  Clear rules should be set because the current FDA regulatory model 
for medical devices is not well suited for low-risk health information 
technologies. In a House Energy and Commerce Committee hearing last 
year, the FDA submitted a letter to the committee that said:

       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 and the average total time 
     from submission to FDA decision was 110 days.

  When regulatory days turn into months, problems are going to persist, 
and that is not something we should leave to discretion. The regulatory 
time line for risky devices should not be the same for low-risk 
software that gets released every 60 days, has major updates every 
month, and sees regular changes every week. Having an approval process 
that takes longer than the shelf life of the average device operating 
system stifles opportunity and it stifles innovation.
  Innovators, regulators, and consumers need clarity and certainty into 
how these regulations are going to be enforced. Since mobile wellness 
apps and most clinical decision support technologies pose little risk 
to patients, they should not be subject to the same costly painstaking 
processes as medical devices. The answer is the commonsense, risk-based 
regulatory approach the PROTECT Act provides. It protects innovation, 
it protects jobs here in the United States, and it protects jobs in 
this U.S.-based job sector. Most importantly, it protects patient 
safety by giving the FDA continued authority and oversight over health 
IT that is risky and by creating an appropriate regulatory framework 
for that which is lower risk.
  With the introduction of the PROTECT Act, I would also like to 
acknowledge the great work of Senator Lamar Alexander of Tennessee, 
Senator Orrin Hatch of Utah, Senator Michael Bennet of Colorado, and 
others who have undertaken this effort in the past. These Senators have 
helped to lay the groundwork for the development of a risk-based 
framework for health IT. The ideas included in the PROTECT Act would 
not be possible without the progress they secured in previous 
Congresses and in the FDA's Safety and Innovation Act.
  I am committed to working with anyone on these issues to exchange 
views and to exchange ideas so we can get the right policy balance our 
country needs and deserves.
  Again, I thank my friends Senator King from Maine and Senator Rubio 
from Florida for joining me in this important effort. Together, we can 
achieve our shared vision of protecting patient safety, protecting 
innovation, and protecting U.S. economic job growth and opportunity.
  Mr. President, I yield the floor.
  The PRESIDING OFFICER. The Senator from Maine.
  Mr. KING. Mr. President, it is a pleasure to join the Senator from 
Nebraska. I love the idea of the surf-and-turf caucus reaching across 
the country to try to find commonsense solutions. I often think about 
legislation and what we are attempting to do, and there is an attempt 
to codify common sense, to try to bring to the regulatory process, as 
it deals with medical devices, a little more thoughtfulness and 
cautiousness as it affects health information technology.
  The first part of the bill actually sets up a process whereby we can 
examine in a thoughtful kind of way some of these issues to reduce the 
regulatory burden and at the same time foster innovation and, very 
importantly, protect patient safety. It sets up a process involving the 
National Institute of Standards and Technology and other parts of the 
administration so that the regulatory process in this area can be 
rationalized across agencies and better coordinated.
  The heart of the bill, however, as the Senator just outlined, is our 
attempt to differentiate between medical software, which has a direct 
impact upon patient health, and software that is more peripheral and 
can range from the app I have on my iPhone, which is a pedometer that 
tells me how much I have walked each day and how much I should walk 
each day, to the kind of software that is being developed across the 
country to assist medical practices in their billing and in the 
operational part of the medical business.
  I think one of the most important points, as the Senator pointed out, 
is that software evolves almost overnight, and if you go through this 
burdensome regulatory process--whether it is 60 days, 120 days, or 1 
year--to get your software approved and then you find there is a bug 
you have to fix, that could restart the whole regulatory process. So I 
think we should acknowledge that this is a bit of preemptive 
legislation because the FDA thus far has not intruded very deeply into 
this process, and we believe it is important in order to define the 
areas where regulation and the protection of patient safety is 
important, but software that manages the billing process of a medical 
practice should not fall into that category and should not be subject 
to that level of regulation. That is really what we are talking about.
  As the Senator mentioned, this law goes back to 1976. In thinking 
about 1976, Gerald Ford was President and software was a mink coat. We 
weren't really thinking about what we are doing today, and of course 
the legislation did not anticipate the kind of intense innovation and 
new thinking that is going on that is able to protect people's health 
just by giving them information about themselves. No doubt the time 
will come when a smartphone will be able to do blood pressure or 
temperature or certainly provide one's heart rate, and that is 
information we should have ourselves, not necessarily regulated by the 
Federal Government.
  I am delighted to join the Senator from Nebraska and the Senator from 
Florida in introducing this piece of legislation. I think it is 
important. It is part of a larger project to try to bring our Federal 
regulatory process into the 21st century where time is of the essence, 
innovation is at the speed of light, and that we can't burden our 
people who are creating these innovations with a lengthy and, yes, 
expensive process that has a tendency to discriminate against smaller 
entrepreneurs and businesspeople.
  I compliment the Senator from Nebraska for bringing this piece of 
legislation forward. I am absolutely delighted to join her in its 
sponsorship, and I look forward to moving it through the legislative 
process. There is a companion piece of legislation in the House, and I 
think this, as I said at the beginning, is an effort to get as close as 
we can to legislating common sense in this area, and I believe it will 
make a difference for businesses, for people, for patients, and for the 
health care system in America.

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