Bradley Merrill Thompson, mHealth Regualtory Coalition

(Music)

Mark Masselli: This is Conversation s on Health Care . I am Mark Masselli .

Margaret Flinter: And I am Margaret Flin t er.

Mark Masselli: Well Margaret , big announcement recently from First Lady
Michelle Obama . She unveiled the new food labeling design that will be required
on all food items sold in this country .

Margaret Flinter: That’s right , Mark . The First Lady unveiled the first revision in
FDA food labeling design in 20 years . The new design will show the calorie
count in much larger bo ld bl o ck letters , and food manufacture r s are going to be
required to show just how much sugar they added to the food item as well .

Mark Masselli: You know Margaret , most health experts point to the introduction
o f high fructose corn syrup into processed food s is one of the driving forces
behind the nation’s obesity epidemic . A majority of the population simply isn’t
aware of the sugar they are consuming in most of the foods everyday .

Margaret Flinter: Another aspect of the new labeling design will show a very
clear portion size and I might say a realistic portion size associated with the
calorie count listed .

Mark Masselli: The First Lady has been a st aunch advocate for promoting better
health across the coun try with her Let ’ s Move Campaign and her pr omotion of
home g ardens and greater emphasis on fresh produce availability . Apparently ,
her staff work ed diligently with the FDA to get this change approved .

Margaret Flinter: And Mark , another new set of rules was recently approved by
the FDA , and that ’s the rules governing oversi ght of medical mobile apps for the
health care industry . Now t hat’s an area as we have talked about often on th is
show that’s just exploded with growth in recent years .

Mark Masselli: Some 100,000 medical and fitness apps no w in the marketplace,
the FDA has issued new guidelines for the growth industry of medical software
and mobile apps to make sure they a dhere to safety requirements , something
our guest today is quite an expert in .

Margaret Flinter: Bradley Merrill Thom p s on is a health law expert wit h a special
emphasis on the FDA , and he will break down these new regulations regarding
mobile medical apps and take a look at some other policies coming out of
Washington that are seeking to regulate th is new and perhaps disru ptive
discipline in the health care arena .

Mark Masselli: Factcheck.org ’s managing editor , L ori Robertson , looks at false
claims that the Affordable Care Act is going to extract hundreds of million s of
dollars o f new taxes on small businesses.

Margaret Flinter: And no matter what the topic , you can hear all of our shows by
going to CHC Radio .

Mark Masselli: And a s always , if you have comments , please email us at
www.chcradio.com or find us on Facebook or Twitte r because we love hearing
from you.
Margaret Flinter: We will get to our interview with Bradley M errill Thom p son in
just a moment.
Mark Masselli: But first , here is our producer , Marianne O'Hare with this week’s
Headline News.
(Music) Marianne O'Hare : I am Marianne O'Hare with these Health Care Headlines. The
clock is winding down towards the end of open enrolment for folks to sign up for
insurance under the Affordable Care Act . Most states wind up open enrollment
by the end of March , and wh ile num bers of those signing up are over 4 million ,
still a long way to go before they reach the target 7 million figure . The President
held a town hall meeting to court one group that should qual ify f o r subsidies in
big numbers, Latinos , many of whom have staye d away from the insurance
exchanges due to lac k of access to good information .
Meanwhile, another campaign out of th e White House is the First Lady ’s Just
Move Campaign , aimed at getting Americans and especially kids to get more exercise to tackle the gro wing obesity problem . The First Lady announcing last
week that those food labels on the sides of food packages are about to get a
whole new look with calorie counts now bolder , the first meaningful change in the
food label design in 20 years . The new lab els will also make more clear what a n
actual portion size is .
A disturbing report out of the Department of Heath and Human Services shows
one in three nursing home or critical care patients , about a m illion patients across
the country are harmed by the he alth care workers treating them , either through
incorrect doses of medication , the wrong meditation altogether or o ther accidents
in care delivery . The study by the Inspector General of the US Department of
Hea l th and Human Services focused on skilled nur sing care , treatment in nursing
homes for up to 35 days after a patient was discharged from an acute care
hospital. The doctors found that 22% of patient s suffered events that caused
lasting harm , a nother 11% were temporarily harmed and in 1.5% of the cas es the
patient died .

I am Marianne O'Hare with these Health Care Headlines .

(Music)

Mark Masselli: We are speaking today with Bradley Merrill Thompson , FDA law
expert and general coun se l for the m Health Regulatory Co alition, the voice for
mHealth techn ology stakeholders in Washington . Mr . Thom p son is an attorney
with the firm Epstein Becker & Green , where he leads the Connected Health
Initiative . He serves as a member of the work group created by the Department
of Health and Human Services and the Fed eral Communications Commission to
identify key considerations in improving patient safety with health information
technology and mobile medical apps . Mr . Thompson was elected as a Fellow of
the American Bar Association and was included in the 100 Most Not able People
in the Medical Device Industry . Mr . Thompson , welcome to Conversations o n
Health Care .

Bradley Merrill Thompson: Thank you so much for having me .

Mark Masselli: Brad, as an attorney specializ ing in health laws with a focus on
the FDA , you have been a driving force in seeking to create some meanin g ful
guidelines for developers and stakeholders in this rapidly expanding mobile
medical app world . And you helped launch the mHealth Regulatory Council to
shape policies that will help the health care industry and embrace the benefits of
mobile cellular communication products and services . Can you give ou r listeners
s ort of the broad overview of the marketplace and talk a little bit about its
stakeholders and the impact mobile medical apps are lik el y having on health care
industry and on consumers ?

Bradley Merrill Thompson: Well you are exactly right . There are so many
different types of apps . But broadly speaking , you can put at least a few of these
app s into some buckets that show kind of the trend f o r where the industry is
going . One of them is certainly the wellness and fitness category , and within
that , there is just a whole s lew of apps that r evolve around tracking key aspects
of body function or exercise or caloric intake for purpose s re ally of helping you to
change your behavior and to become healthier . There is this philosophy that if
we do a better job of tracking health information , we can do a better job of
managing it . In addition to that , there is a whole sle w of apps that really are
designed to try and get typically consumers , sometimes doctors , the best
available information on a given subject . So whether it ’ s maybe a rare disease ,
there are apps that simply help you organize all of the educational material s
related to that dis ease . Then there is a variety used in remote monitoring and so
it’s a way to collect information often from a medical device and kind of te ther you
to your doctor . So if you are a person with diabetes and you need to manage
your blood glucose , then it be comes a way to transmit that data back to your
doctor .

One of the really exciting areas that’s really growing significantly i s what’s called
clinical decision support software , and that’s a big name for simply the analytics
that are used on data now to he lp with the diagnosis of disease , help with
identifying the most likely or e ffective treatment . So that’s an exciting area . You
have a variety of products that are really just physician tools . We really want to
figure out a way to make physician s more e fficient . There is a physician
shortage but there is also frankly just ever - growing need to bring cost out of the
health care system . So if we can arm a doctor with a tablet and that tablet can
be used to pull up lab values , it simply makes the doctor mo re efficient as he
encounters patients . Even the pharmaceutical industry is getting into the game .
I have been reading about apps lately that are used for a variety of things from a
Sma rt Pill which simply tells you -- it actually tracks when you take you r
medication down to the minute in order to help particularly the elderly o r anyone
who just lose s track of whe ther they have taken their medications . But even
more cutting edge , there are apps that help you decide whether a given drug is
appropriate for you because the use of the drug can be guided in effect by a
mobile app . Clinical trials , mobile health is completely revolu tionizing the way
they organize clinical trials and medical device manufacture r s are all of a sudden
realizing that the ir devices a re going to be electronically tethered to every other
part of the health ecosystem and that raises a host of issues around
in teroperability . So it ’ s really affecting everyone .

Margaret Flinter: Well Brad , I want to talk about regulation for just a minut e .
You r work with the mH ealth Regulatory Co alition has come in two phases since
forming in 2010 , the first one help ed facilitate the development of basic
guidelines that we re passed by the FDA at the end of last year t h at gave some
regulatory framework in the medical app marketplace . So maybe tell us what
kind of apps will be governed by this first round of FDA guidelines and what
essentially do the guidelines serve to achieve?

Bradley Merrill Thompson: To be honest, one of the big challenges that we ha ve
in th is space is the investors needing to know is a particular app that is being
developed going to be regulated by FDA or not . And the reason they want to
know that is quite simple ; it dramatically impacts the cost of the development of
the product bu t also the timeline for the development because you have to factor
in compliance with FDA before going to market . So knowing what FDA is going
to regulate w as just pivotal really to a lot of start ups getti ng the funding that they
needed . And it addressed typical fashion 80% of the open questions , the basic
questions anyway and left about 20% that were still kind of fu zz y . But that 80%
was a big win for the industry because it meant that if you we re developi ng an
app in that space , you c ould relatively cl early is FDA going to regulate it or not .

So what do those guidelines say ? We ll basically it identifie s two different apps or
two different categories of apps that might be regulated . The first one is where
an app is functioning as a n accessory to a med ical device . So let ’ s say you

make a blood glucose meter and you want to produce an app that will be used
maybe to control a blood glucose meter, maybe it will take the reading s out of the
meter and it will graft them on your cell phone . FDA said if you are making an
app to be a n accessory to a medical device , the app will be regulated . Well you
know , truth be told , that’s pretty commonsense . I think we expected that
because if the accessor y doesn’t work , it can mea n the whole medical device
doesn’t wor k .

The second category is equally intuitive but it was nice that FDA kind of laid it out
there and then gave a whole bunch of example s and that is whenever you have
an app that does the same thing that historically a medical device has done , you
can expec t the app to be regulated . There are lot of example s, a simple one
being an electronic stethoscope . Stethoscopes ha ve always been regulated so if
you take an i P hone and you use the microphone on the phone as a way to listen
to the heartbeat and the app b asically translates it into a meaningful sound, that’s
basically an electronic stethoscope and it would be regulated. A little bit more
sophisticated would be an example of an app that came out last spring to do
laboratory testing on urine. What you actu ally do is you test urine in a cup. You
put a test strip in the cup of urine, you take it out and you use the camera on the
phone to basically read and measure blood glucose levels and a variety of other
substances that you test urine for. And FDA basica lly said , “Look , in the past, a
cash register size machine used to do that; now it’s on a cell phone. That’s
terrific. But it’s doing the same thing as a medical device, therefore it’s
regulated.” So really those are the two buckets. Once they laid tha t out, folks
were able to decide whether or not it was regulated and investors were able to
understand what the cost was.

Mark Masselli: I want you to talk to our listeners about this larger role that you all
are playing with various regulatory bodies. The Federal Communications
Commission is involved; the FDA is involved . And how are you helping shape
their thinking about the mobile medical app world and what are some of the
concerns that consumers might have, safeguards in terms of security or how are
you trying to help shape the regulatory thinking about this new arena ?

Bradley Merrill Thompson: Well that’s a key question is making sure that we
have clarity not just on what the rules are but frankly which agency has the
responsibility to make those rules. So FDA’s role with all technology is to make
sure that the technology does what it says it will do and does it in a manner that
is safe and effective. But when you are talking about technology that sits on a
cell phone and a key aspect of the func tionality then is transmitting those results
or information or whatever it might be, you necessarily involve the FCC because
they control the airwaves and they control by and large the devices that transmit
over those airwaves. So you have simultaneously a cell phone that may be
functioning as a medical device and at the same time is functioning as a cell
phone, piece of a communication equipment. So it’s really important to parse out
which agency has responsibility for a given question and to get those a gencies

talking with one another , and fortunately they have been. As I understand it, I
think they have a standing meeting on Thursday afternoons where they talk
about what each of them is doing and making sure that they are coordinating, not
frustrating, the industry.

You layer on to that the overall federal policy of trying to encourage the adoption
of electronic health records. Mr. Obama committed $20 billion basically to
encouraging the “meaningful use” of electronic health records. And a lot of thi s
stuff dovetails with electronic health records because it is data that might get
deposited into an electronic health record. So the connectivity to that is very
substantial. So you get O N C, Office of the National Coordinator involved as well.
The key is that they talk to each other because the worst thing that could happen
in my opinion would be agencies working against one another, working in
opposite directions, giving conflicting signals. So I do think there is a strong
effort within the administra tion to make sure that they are coordinated.

Margaret Flinter: I also understand it’s not just the federal agencies but
Congress itself in the House and Senate that is looking to change the oversight
of medical mobile apps and I found that somewhat surpr ising. What are these
pieces of legislation and is there a role for Congress in this? Do you think that
this will also help or hinder the growth of the use of medical mobile apps?

Bradley Merrill Thompson: So there are two pieces of legislation that ha ve been
introduced, one in the House and one in the Senate. The House bill is called the
SOFTWARE Act and the one in the Senate is called the PROTECT Act. Overall,
the thrust of both pieces of legislation is removing from FDA regulation a whole
variety o f health information technology, including a variety of mobile apps. I
think basically they want to avoid FDA regulation. That’s what the legislation
does. So it seems that must be their intent . I have publicly honestly come out
against both of those b ills because I think they would be bad for the industry , and
I have a few reasons for that . The first is they take some very important and
frankly , risky software and remove it from FDA regulation . I will give you an
example.

Let’s say you wanted to dev elop an app for detecting melanoma , and there is this
technology being developed . You basically would take picture of a mole on your
skin and then maybe six months or a year later you take another picture and the
software compares the two pictures and the n offers a view on whether the re are
any changes to the mole such that it might indicate melanoma and you ought to
go see a doctor. The legislation would deregulate that and I can’t for the life of
me understand that . And it’s not just that . That’s not good for patient s . I think
patient s need to have greater confidence that an app that they rely on not to seek
medical care actually works . But it ’ s also bad for industry because the worst
thing that could happen to industry is patients getting hurt . It is terribl y important
that both patients and doctors believe that the apps that are out there will do
what they say they will do. I saw just last week a study result s that were

released . I think 250 physicians were surveyed and 42% of them say that they
don’t prescribe mobile apps because they aren’t regulated and they therefore
have concerns about whether they work o r not. Well that’s a big limitation . If you
are trying to convince users that an app h as value and they are concluding that
because it ’ s n ot regulated it may have dubious value , that will hold back the
development of the more important side of the app spectrum. You will still be
able to develop games no problem but if you really want to move the needle on
public health , you need that pubic confidence.

Mark Masselli: We are speaking today with Bradley Merrill Thompson , FDA law
expert and general coun sel for the m H ealth Regulatory Coalition, the voice for
mHealth technology stakeholders in Washington. Mr. Thompson is an attorney
with the fi rm Epstein B ecker & Green where he leads the Connected Health
Initiative . Brad, I want to sort of pull the thread on that thought that you had there
about the need for having regulatory engagement and you have decided to take
it down the road , you have go t a road show coming up , the m H ealth Educational
Outreach Tour to various institutions to better educate c linicians and developers
at some of the top research and teaching hospitals around the country . So tell us
a little bit about when you will be going out and where you will be headed .

Bradley Merrill Thompson: We have already been several places. We have
been to Stanford and the University of Illinois and we are going to be at MIT and
we are also going to be at a place called The Innovation Center in C leveland ,
O hio and we are also going to Berlin . There is a big program over there ,
m H ealth Summit in Europe . And basically the objective is to create a community
around people in the m H ealth space who are basically dealing with FDA
regulation . And at this point , there are well over a hundred companies that have
navigated the FDA process for a mobile app . And so we are drawing on those
people who have the expertise of having been there , done that and we are
organizing p a n e l discussions where they can b asically share their experiences
good, bad or indifferent, the lessons that they learned frankly in order to keep
from making mistakes in their future , really in the hope number one , of
developing best practices , how exactly do you get through the FDA proc ess most
efficiently b ut also to learn frankly some of the benefits of having done so .

Some of the companies talk about what it cost , what the investment was and
what they perceive t he benefit to have been . And ultimately the goal is to sort of
foster me ntorship , to get some of these experience d entrepreneur s connected
with those who don’t have the experience so that they can form kind of informal
support networks and help one another as they try and navigate this . So it’s
been exciting to watch , to see these folks come together and help each other.
The u niversities have been great . There are about a dozen national and
international organizations that are sponsoring it, professional societies . And the
discussions that we have had with these entrepreneu rs have just been
fascinating to find out what they are working on and what their challenges are.

Margaret Flinter: We have been speaking today with Bradley Merrill Thompson,
FDA law expert and general counsel for the mHealth Regulatory Coalition. You
c an learn more about Mobile Medical Apps Roadshow and his work by going to
www.mhealthregulatorycoalition.org . Brad, thank you so much for joining us on
Conversations on Health Care today.
Bradley Merrill Thompson: Well thanks very much for having me.
(Music) Mark Masselli: At Conversations on Health Care, we want our audience to be truly in the know when it comes to the facts about health care reform and policy. Lori Robertson is an award - win ning journalist and managing editor of
FactCheck.org, a nonpartisan, nonprofit consumer advocate for voters that aim to reduce the level of deception in US politics. Lori, what have you got for us this week? Lori Robertson: Well Republicans have claimed for years that the Affordable
Care Act taxes small businesses and families. Most recently, Senator Tim Scott of South Carolina made the claim that the ACA’s taxes of $800 billion hit those two groups, small businesses and families. But that’s misleading for several
reasons. First, the claim overlooks the tax credits available to those groups. Second, there are few taxes directly affecting small businesses . And third, the
10 year figure Scott gave mainly affects individuals earning more than $200,000 a year. The $800 billion number is an estimate from the Congressional Budget
Office and Joint Committee on Taxation on how much government revenue would be lost over a decade if the ACA were repealed. So keeping the law in place would increase government revenue by the same amount. But the law also includes about $600 billion in net government spending over the same time
pe riod, and included in that, is $519 billion in premiums and cost sharing
subsidies that would go to families. Hundreds of millions of dollars more paid for
Medicaid expansion also benefiting families and even small businesses whose employees may gain insurance coverage that way.
Now the families getting subsidies aren’t the same ones getting hit by the ACA taxes. A family of four earn ing up to $95,400 qualifies for subsidies or Medicaid
for lower income earners. About 40% of those $800 billion in taxes however affects families earning more than $250,000 a year or $200,000 for individuals. That’s subject to higher Medicaid payroll tax es and a new 3.8% tax on
investment income. Those folks are certainly families but they represent less than 2% of taxpayers. And that’s my fact check for this week. I am Lori Robertson, Managing Editor of FactCheck.org .

Margaret Flinter: FactCheck.org is committed to factual accuracy from the
country’s major political players and is a project of the Annenberg Public Policy
Center at the University of Pennsylvania. If you have a fact that you would like

checked, email us at www.chcradio.com . We will have FactCheck.org ’s Lori
Robertson check it out for you here on Conversations on Health Care.

(Music)

Margaret Flinter: Each week, Conversations highlights a bright idea about how
to make wellness a part of our c ommunities and everyday lives. During the
school year, some 21 million American children receive free or reduced price
lunches through their schools, often the healthiest meal these children eat during
the school day. Yet, when school is out, only 10% of these children participate in
the free meal programs during the summertime, and studies have shown that
many of these kids tend to gain a significant amount of weight over the summer
as a result. A group of researchers at the University of South Carolina sought to
tackle that issue with a program they developed called the Healthy Lunchbox
Challenge. They deployed the program at a number of large community - based
summer day camps, and lead researcher Dr. Michael Beets says they relied on a
simple known fac t about kids, they love competition.

Dr. Michael Beets: Staffers during the first snack period would ask kids to hold
up the fruits or vegetables or water that they brought and then at the end of the
week they announced the winner of the Healthy Lunchbox Challenge for that
week.

Margaret Flinter: Dr. Beets says the simple competition and group rewards
system created a dramatic shift in the average camper’s lunch box from chips,
cookies and sugary drinks to more fruits, vegetables and bottled waters.

Dr . Michael Beets : So kids are not just bringing additional fruits, vegetables and
water, they are substituting these healthier items for the less helpful items.

Margaret Flinter: The study published in the Journal of Nutrition Education and
Behavior show ed a dramatic shift in the kids’ homemade lunches with this really
simple and inexpensive incentive program. They see this as a model for summer
day camps across the country , which serve some 14 million children per year
often in underserved areas. The n ext phase of their study will look at the actual
weight and body mass index of kids in the next round of campers to calculate the
impact on lowered weight gain. The Healthy Lunchbox Challenge , a simple
competitive challenge and rewards system designed to get kids to switch out
high fat, high sugar, high calorie foods from their diets in favor of healthier snacks
and beverages, now that’s a bright idea.

(Music)

Margaret Flinter: This is Conversations on Health Care. I a m Margaret Flinter.

Mark Masselli : And I a m Mark Masselli, peace and h ealth.

Conversations on Health Care, broadcast from the campus of WESU at
Wesleyan University, streaming live at www.wesufm.org and brought to you by
the Community Health Center.