Digital Medicine Society Executive Director Jennifer Goldsack on Need for Standards in This New Era in Medicine

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[Music]

Female : Welcome to Conversations on Health Care with Mark Masselli and
Margaret Flinter a show where we speak to the top thought leaders in
health innovation , health policy , care delivery and the great minds
who are shaping the health care of the f uture. This week Mark and
Margaret speak with Jennifer Goldsack, Interim Executive Director of
the newly formed Digital Medicine Society, which seeks to put
standards in place for the multiple stakeholders entering the growing
st
world of digital medicine . 21 century technology - driven health care
that will make it possible to develop digital medicine that ’ s more
precise and effective, more experimental and more widely
distributed.

Lori Robertson also checks in , the Managing Editor of FactCheck.org
look s at m isstatements spoken about health policy in the public
domain , separating the fake from the facts . W e end with a bright idea
that ’ s improving health and well - being in everyday lives. If you have
comments please email us at [email protected] or find us on
Facebook or Twitter or wherever you listen to p odcast . Y ou can also
hear us by asking Alexa to play the program Conversations on Health
Care . Now stay tuned for our interview with Jennifer Goldsack here on
Conversatio ns on Health Care .

Mark Masselli: We ’ re speaking today with Jennifer Goldsack, Interim Executive
Director of the newly launched Digital Medicine Society or D i M e , the
first professional organization for experts from all disciplines
comprising the diverse fi eld of digital medicine. She is VP of Digital
Measurement at monARC Bionetworks. Prior to that, she spent
several years at the Clinical Trials Transformation Initiative. Ms .
Goldsack earned her master ’ s in chemistry from Oxford University,
her masters of h istory and sociology of medicine from the University
of Pennsylvania and her MBA from George Washington University.
Jennifer, welcome to Conversations on Health Care.

Jennifer Goldsack : Thrilled to be here and thank you for having me.

Mark Masselli: You kn ow, and we ’ ve had many guests and had many conversations
about digital medicine and it really seems to infiltrate every aspect of
health care . W e ’ ve seen a lot of things happen in this past decade that
were exciting and it ’ s kind of surprising to see that a society hadn ’ t
yet been formed, to help guide this evolving aspect of modern health
care. What ’ s D i M e ’ s description of di gital medicine and why are you
and your likeminded colleagues launching this venture? Tell us a little
more about it?

Jennifer Goldsa ck : Wh en we describe digital medicine, I think the most helpful way to
think about it is concentric circles. B roadly digital health being this
very wide sphere of digital tools that support health and wellness

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initiatives . W ithin that we would define digit al medicine specifically as
one those software based tools designed to support the practice of
medicine, whether that ’ s diagnosis, whether that ’ s treatment,
whether it ’ s monitoring, assessment population health management.
But critically important, we are hoping to insist on digital medicine as
being an evidence based field. Specifically those digital medicine tools
or those software based tools that support the practice of medicine
very broadly, but are evidence based . W ithin that definition you
would have digital therapeutics , s o digital therapeutics would be a
subset of digital medicine, but obviously those diagnostic, those
measurement, those population health management tools, which
comprise the rest of the field.

You know, when I talk with not just my colleagues within the
leadership of DiM e , but frankly everyone who ’ s been joining us i s a
member and many folks who have been affected by the field . W hat
we see is huge promise, huge potential to improve health , health
care, to reduce costs, to make it eas ier to access care. These are
things that sort of as an industry we ’ ve been battling with for decades
now with unfortunately quite little success. The reason I think the
timing is right is the rate of innovation, the rate of growth of these
digital medicin e tools. On the one hand it ’ s proven the possibility,
right? I think we ’ ve started to see evidence that these tools can have
an impact. But at the same time it ’ s been really difficult to keep pace
with that evidence based . H ow can we make sure that the too ls we ’ re
being asked to put our trust within are indeed trustworthy ? I think
that ’ s why this juncture is so important , a nd that ’ s why the timing is
right for a society like DiM e .

Margaret Flinter: Well, Jennifer, as you ’ ve made clear already, digital medic ine offers so
much promise, but I want to talk about these big challenges that
you ’ ve laid out. I was kind of surprised at the lack of evidence being
one of them. I thought we were further down the road with that. The
second of three areas that you ’ ve iden tified as problematic doesn ’ t
surprise me at all , t he fragmentation of data . T he third isolated silos
of progress surprises me the least. Maybe share with us what you and
your organization are planning to do about addressing these specific
challenges so th at you can make the progress that you think digital
medicine has to offer us ?

Jennifer Goldsack: L et ’ s start with evidence. I think it ’ s not up to a society to build the
body of evidence for each of the individual d igital m edicine tools that
we expect to s ee being rolled out and frankly, that are currently being
used. But I think one of the challenges is that these are brand new
products being deployed in a very different way . H ere ’ s an example I
always use , i f you ask an engineer and you ask a clinician wh at does
validation mean? They mean vastly different things. H ow can you
build towards a common body of evidence if actually the evidence

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being generated, that level of evidence, that framework of
information that end users, whether that ’ d be a payer , presc ribing
clinician or a patient, how can we ask them to discern between
different tools, know that they ’ re safe, know that they ’ re effective if
actually we ’ re not starting from the same foundation.

S imilarly, I think that have many brilliant engineers, techn ical experts
entering a field that ’ s highly regulated and that perhaps they haven ’ t
previously understood that there is a certain level of evidence that
needs to be introduced. Similarly on the clinical side, really getting our
clinical experts comfortable with the way that software is developed ,
so t hat ’ s the piece that we ’ re seeking to address on the evidence side
of things. I don ’ t think it ’ s up to society to be the decision maker on all
of the different d igital m edicine products. But certainly take very
seriously the responsibility of building a common framework for
generatin g and evaluating that evidence.

The second piece is you mentioned is fragmentation , and as I just
mentioned, it ’ s not just the fragmentation of data, it ’ s these
disciplines colliding , and how can we facilitate communication and
education across in between those fragmented disciplines and
experts. T he final piece that that didn ’ t surprise you at all, Margaret,
was these sort of isolated silos of progress. T he reason I think that
DiM e i s so important is d igital m edicine is the most interdisciplinary
field I can think of and I don ’ t think it ’ s an overstatement. We really
need to have sort of white hat hackers at the table with payers and
regulators. We need to have privacy and security ex perts talking with
the product experts, with the clinicians, with the patients to see how
the access and the functionality that they want jives with concerns
about data security, data storage. How do we actually handle this?
More data is not always better. How can we thoughtfully think about
what we collect and how it impacts ? Those isolated silos of progress,
we helped to be able to convene these experts and really share in
advance a common understanding and a collaborative approach.

Mark Masselli: Jennife r, you have these building blocks that are in place for the work
that you ’ re doing. The base level is that we have the advent of the
scaling of electronic health records. You ’ ve got patients across the
country who are connecting themselves to wearables, o b viously you
have some large tech companies that are pushing wearables and
people are engaged in them. T hen you have this whole advent o f
st
technological age of the 21 c entury. T ell us really where you are on
your pathway of building this new society.

Jenni fer Goldsack: It is an enormous task , Mark, but it ’ s that throwaway phrase of, how
do you eat an elephant and you take the first bite , and I think that ’ s
really important. We can ’ t be paralyzed by the enormity of the task. I
think there was recent data tha t came out that said, the d igital

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m edicine field will be valued at 250 billion by 2023 or something and
you think, well, gosh, we ’ ve got limited regulations and standards and
evidence right now. How do we keep up? I ’ m really proud of DiMe in
that respect a nd our leadership. We really only started talking about
this in November and we pushed incredibly hard and already have
members worldwide hundreds and hundreds , i t ’ s wonderful , t here ’ s a
thriving community already.

I think other critically important pieces will be doing this
collaboratively. The army of one approach won ’ t work , and
importantly, prioritizing which are the ones that currently are most
pressing to ensure that these digital tools that we ’ re placing our faith
in are indeed safe and effective. T h en the final piece that I think is
really important, we are incredibly fortunate with the strategic
advisory and the scientific leadership boards we have as part of our
governance structure at DiMe .

I think what we would all agree is it ’ s a new era that it ’ s this collision
of these two different fields that think very differently . B ut at the
same time we don ’ t have to completely tear up the playbook. There
are scientific principles that should always prevail and just because we
may need to extrapolate them to a new world doesn ’ t mean we
throw the baby out with the bath water. A lot of what we ’ re doing is
thinking critically about how can scientific and ethical standards, how
can they be extrapolated to this new era?

Margaret Flinter: Well, one of the areas t hat we ’ re particularly interested in is research.
You may know that our organization ’ s been part of the All of Us
Initiatives since the beginning. C ertainly thinking about how that
works both for us locally as one organization, but also watching just
the t remendous work being done at the national level on that project,
and you ’ ve done research on leveraging technology to improve
mobile clinical trials. How might clinical trials and research for the
betterment of all be really transformed by digital int erven tions in the
future?

Jennifer Goldsack: It ’ s a really good question. T here was actually a lovely piece that came
out I think sometime last year by Eric Topol and Steve Stein h ubl. T heir
op - ed I think was something along the lines of d igital m edicine on its
way to being just pain medicine , and we don ’ t say computers in
business, they ’ re just ubiquitous. Eventually I see that being the case
in clinical trials. I ’ m really optimistic about how these digital
technologies can affect clinical trials. F irst ly I thin k that these tools can
power better quality, more patient centric endpoints, specifically ones
that will generate sort of better and more complete information
about how potential new therapies work. I think that these tools
could potentially support improv ed recruitment and retention, which
we know are huge burdens in industry right now. They ’ re driving up

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costs, they ’ re slowing progress. We can do that by developing sort of
endpoints that matter to patients, measuring them remotely with far
reduced partici pation burden.

I think another sort of way that these tools will impact clinical trials is
if you can have a more sensitive measure one that is sampling almost
continuously have a much greater data density. We have much more
chance of making better decisio ns in early phase trials. We can fail
faster and we can succeed much more cheaply and quickly , ultimately
setting us up for sort of increased success for potentially successful
treatments. T hen this data density really just driving the whole trial
life cyc le, so I always think of Alzheimer ’ s as being such a devastating
condition , w e know very well, the heartbreaking and expensive late
stage failures we ’ ve had with drug development. I t continues to
amaze me that the gold standard end po int in Alzheimer ’ s, the UPDRS
scale was first introduced in 1987.

It ’ s a physician administrated paper tool that ’ s done once a visit, but
yet this is an episodic condition. This is a condition where we see the
symptoms playing out on an irregular basis . W e also know the burden
t o patients and caregivers of this disease. If we can stop putting the
burden on patients to come into the clinic and only rely on snapshots
of information to drive the trials , and i nstead if we can put digital
measurement tools out there in the field to po wer these studies to
get very good high quality data rich information very quickly about
whether a new therapy might be successful. I think that could
revolutionize the way that we think about clinical trials.

Mark Masselli: We ’ re speaking today with Jenni fer Goldsack, Interim Executive
Director of the newly launch ed Digital Medicine Society or DiMe , the
first professional organization for experts from all disciplines
comprising the diverse fields of digital medicine. Jennifer, one I really
like your North Star that this really needs to be an interdisciplinary
collaboration.

Jennifer Goldsack: Absolutely.

Mark Masselli: That that resonate s in the era of team based care, a nd there are a lot
of folks that you ’ ve got engaged in this ethicist, clinicians, resear chers,
white hat hackers. I ’ m also wondering on the tech side, are you
engaging people who are trying to advance the technology or are you
pretty much letting the tech stuff happen and then monitoring it and
setting the standards for it?

Jennifer Goldsack: The way we think about our leadership, the way we think about Di Me
membership and the way , frankly , we think about the field and its
success and advancing it for the betterment of sort of health and for
patients. We really think about a setting at the int ersection of
healthcare and technology. For all the clinical experts we have, we

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also have that representation from the tech side. We are seeking
input and expertise and collaboration all the way from those
infrastructure experts you ’ ve mentioned can sort of power it with
those broad brush strokes . A ll the way through to those software
engineers and data scientists who are sort of crunching those
algorithms to develop very specific measures. It ’ s funny because I feel
like sometimes I ’ m clinical experts, are worried about being squeezed
out and that ’ s absolutely not the case. I don ’ t think we can
underestimate how important it is to remember that this is still health
care , t he se are still health care tools, r ecognizing that the tools of this
era, of th is cent ury and of the future are digital ones. We need to
promote that common understanding.

Margaret Flinter: O ne of the elements that maybe needs to get teased out a bit is this,
are there ethical considerations when we say digital medicine ? A re
there ethical c onsiderations that are different from the other ethical
considerations that we all know from, starting first and foremost with
do no harm. Is there a group that ’ s looking at whether there are
specific ethical considerations to really be defined?

Jennifer G oldsack: The ethical considerations are indeed very unique in this era of digital
medicine. When we are gathering data and information directly from
patients when they go about their daily lives, we are obviously
understanding and documenting and recording information about
them that we never have done in health care. You see things like the
terms of use d agreements, the privacy policies that you ask patients
themselves to sort of re review and agree to without that
intermediary. That ’ s extraordinary when y ou think about reducing
costs , when you think about improving access b ut there ’ s absolutely
ethical implications there. Yes, I think this is very unique. The last
piece of that too is the flow of the data, the data flow is differen t to
how it existed previ ously in these static paper document forms
where, only the people with their hands on the physical data could
access it.

Now many, many people can access any given data point and there
are vulnerabilities at all sorts of different points in the chain that we
need to be aware of. Again, there ’ s a tradeoff between the access and
privacy. I think that that tradeoff is really important , y ou mentioned
to do no harm and that always has a connotations with it , t he
hippocratic oath that clinicians swear to when the y launch their
career. There ’ s a fantastic organization , I am the cavalry , who have
come up with a security focus hippocratic oath for connected devices.
I recommend if anyone listening hasn ’ t read that yet, take a look at
that and consider it. Then the la st piece, I think we take the need for a
very, very, focused ethical framework that really is sort of patient
centric.

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We ’ re actually currently building a working group to advance work
ethics in digital medicine right now and it really needs to be
collabor ative. It ’ s interesting. I have seen some quite high profile sort
of documents and ten principles spin out . T hen you look at who was
in the room and there wasn ’ t a patient in sight and you ’ re just think,
well, my personal op inion is that that ’ s a mistake. I also think that
collaborative approach is because there are new problems to solve
for. Some of the data access, the sheer volume of data and
information we have on any individual and how that allows us to
connect dots that we never have been able to befo re. These are new
challenges and that ’ s why we ’ re excited to tackle this and think we ’ re
well placed to do so.

Mark Masselli We have been speaking today with Jennifer Goldsack, Interim
Executive Director of the newly launched Digital Medicine Society or
Di Me, the first professional organization for experts from all
disciplines comprising the diverse field of digital medicine. You can
learn more about their work and add your own voice to the
conversation by going to dimesociety.org or you can follow them on
Twitter at @_DiMeSociety . Jennifer this is really important work. It ’ s
timely and we appreciate your forward thinking and thank you for
joining us on Conversations on Health Care .

Jennifer Goldsack: Mark and Margaret thanks for having me.

[ Music ]

Mark Mass elli: 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 winning 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: Recently t wo d emocrats, Senator Kirsten Gillibrand and former
president Barack Obama distorted the facts on the public health issue
of guns. Gillibrand a d emocratic p residential candidate claimed
President Donald Trump failed to keep his promise after a mass
shooting in Las Vegas in 2017 to ban bump stocks. Trump may not
have moved as quickly as Gillibrand would ha ve liked, but Trump did
enact a bump stock ban, which went into effect in March. At a town
hall event hosted by Fox News in June Gillibrand said Trump was
“ beholden to the NRA ” claiming he said he was going to ban bump
stocks but didn ’ t because of the NRA.

Shortly after the Las Vegas shooting, the NRA said it didn ’ t support a
total ban on bump stocks or legislative action. It preferred revised
regulations from the Bureau of Alcohol, Tobacco, Firearms, and
Explosives. A bump stock is a plastic or metal devic e that can be

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attached to the rear of a semiautomatic rifle to make it shoot almost
as fast as a fully automatic weapon. It did take some time, but
th
ultimately on December 18 , 2018 the Department of Justice and ATF
issued a new federal regulation official ly banning bump stock. The
rule required the owners of any bump stocks to destroy the device or
th
turn them in at an ATF office prior to March 26 when the rule went
into effect .

An NRA spokeswoman said the organization was disappointed with
the rule becaus e it didn ’ t provide a grandfather clause for those who
already had the devices. Gillibrand ’ s campaign told us she was
referring to the time right after the Las Vegas shooting when Trump
initially supported a bump stock ban and then f aced NRA criticism. At
a technology conference in Brazil former p resident Obama
misrepresented US g un l aws claiming that , “ A nybody can buy any
weapon without much if any regulation . ” including he said , “M achine
guns. Machine guns have been tightly regulated since 1934 and
ban ned since 1986 except for the sale or transfer of such a weapon
that was lawfully owned and registered before May, 1986.

A machine gun is defined by law as one that can shoot automatically
more than one shot with a single trigger function without manual
reloa ding. A spokesman for Obama said the former president used
the term machine gun when he meant semiautomatic weapons that
are currently illegal to purchase in the US such as AR - 15 rifle. That ’ s
my fact check for this week. I ’ m Lori Robertson, Managing Edito r 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 ’ d
like che cked, email us at www.chcradio.com , we ’ ll have
FactCheck.org ’ s Lori Robertson check it out for you here on
Conversations on Health Care.

[ Music ]

Mark Masselli: Each week Conversations highlights a bright idea about how to make
wellness a part of our communities and everyday lives. One in five
Americans will suffer a diagnosable mental health condition in a given
year and most often don ’ t seek treatment. Seeing a rise in mobile
apps aimed at behavioral health entering the marketplace, the
University of Washington researcher Dror Ben - Zeev thought a
comparative effect ive analysis study would be a good idea.

Dror Ben - Zeev: My team and I conducted a three year comparative effectiveness trial ,
w ith the objective of having a head - to - head comparison between a
mobile health intervention for people with serious mental illness
called Focus and a more traditional clinic based group intervention.

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It ’ s conducted at a clinic setting, people with similar diagnoses . T he
study really ge ts at some of the core differences between mobile
health and clinic based care.

Mark Masselli: More than 90% of the mobile app group engaged in the online
program which was a series of text messages offering coping
strategies and self - monitoring of symptom s along with weekly call - ins
with the behavioral health clinician.

Dror Ben - Zeev: We measure d to see whether involvement in both interventions for a
12 week period would that create some sort of difference in
psychiatric symptom severity and 90% of the ind ividuals who were
randomized into the mobile health arm actually went on to meet a
mobile health specialist to describe the app to them and train them
how to use it and use the intervention app that ’ s assigned to them at
least once. Whereas in the clinic b ased arm, we saw that only 58% of
the participants assigned to that clinic based intervention ever made
it in for a single session.

Mark Masselli: Ben - Zeev says, this suggests that mobile therapies may provide a
useful tool for clinicians having trouble ge tting those with serious
mental health issues to engage with the clinical interventions.

Dror Ben - Zeev: The group dynamics that on its own is quite potent for people, but for
others the interaction is anxiety provoking . W hen it comes to the
clinical outcom es in both intervention arms, people improved both in
terms of reduction in their symptoms and the distress associated with
symptoms and improvements in their recovery.

Mark Masselli: A targeted mobile app aimed at facilitating access to clinical care for
those experiencing serious mental illness symptoms, proving equally
effective in managing the condition , improving access to intervention
for behavioral health needs. Now that ’ s a bright idea.

[ Music ]

Mark Masselli: You ’ ve been listening to Conversations o n Health Care. I ’ m Mark
Masselli.

Margaret Flinter: And I ’ m Margaret Flinter.

Mark Masselli: Peace and health.

Female : Conversations on Health Care is recorded at WESU at Wesleyan
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