[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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