FDA Webinar

Moderator: Irene Aihie

10-19-20/11:00 am ET

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Digital Health Center of Excellence Listening Session #1

Moderator: Irene Aihie

October 19, 2020

11:00 am ET

Coordinator: Welcome and thank you for standing by. At this time, all participants are in a 

listen-only mode until the question-and-answer session of today’s conference. 

At that time, you may press star 1 on your phone to ask a question. I would 

like to inform all parties that today’s call is being recorded. If you have 

objections you may disconnect at this time. I would like to turn the conference 

over to Ms. Irene Aihie. Thank you. You may begin.

Irene Aihie: Thank you. Hello and welcome to today’s FDA webinar. I’m Irene Aihie of 

CDRH’s Office of Communication and Education.

On September 22, 2020, the FDA established the Digital Health Center of 

Excellence also known as DHCoE. The DHCoE is a part of the planned 

evolution of the Digital Health Program in the Center for Devices and 

Radiological Health. It marks the beginning of a comprehensive approach to 

digital health technology setting the stage for advancing and realizing the 

potential of digital health.

Today Bakul Patel, Director of the Digital Health Center of Excellence in 

CDRH will moderate today’s listening session for digital device 

manufacturers, developers, healthcare providers, researchers and stakeholders 
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to learn about the Digital Health Center of Excellence. The FDA will discuss 

the purpose and functions of the DHCoE and will focus on collecting 

feedback from attendees.

Now I give you Bakul.

Bakul Patel: Thank you, Irene. If you can get to the next slide, and good morning 

everybody, welcome to the First Listening Session for the Digital Health 

Center of Excellence.

I’m joined here today by Dr. Jeff Shuren, Director for Center for Devices and 

Radiological Health, Zach Rothstein, AdvaMed representing MedTech 

industry, Rene Quashie representing the tech industry, Consumer Technology 

Association, Megan Coder representing the emerging field of digital 

therapeutics from the Digital Therapeutic Alliance, Heidi Dohse representing 

the patient’s perspective from Tour de Heart, and Bill Evans representing the 

Entrepreneur Committee from Rock Health.

We are having this session today as a panel discussion to discuss two main 

topics on the goals and outcomes of the Center of Excellence and how best we 

can collaborate.

But before we get further into that conversation and I encourage everybody to 

have focus on this - on these two topics we’re going to talk today and ask 

questions, provide perspective. This is a listening session. So I’m going to 

keep my remarks rather short and give you sort of what we have outlined as 

our goals, our objectives, what we are focusing on and a roadmap of how 

we’re going to continue to build the Center of Excellence that will actually 

truly empower everybody.
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On the next slide, Irene, I want to share sort of the top level goal for the 

Digital Health Center of Excellence. We truly would like to empower digital 

health stakeholders to advance healthcare. We believe digital health has the 

potential to change healthcare to the next era.

On the next slide you’ll see how we are envisioning digital health to improve 

healthcare. Digital health is a convergence of connectivity, data and 

computing power for healthcare and it’s related use is across the life of an 

individual or a patient is really moving healthcare from the clinic to the 

patient and trying to understand patient’s behavior in its - in the wild. And 

really a lot of these technologies have been focusing on prevention and earlier 

and smaller interventions.

This is all happening with the advent of sensors, computing power and 

connectivity that is connecting everything together and people and patients 

together with software.

On the next slide, you will see where we are focusing on in terms of FDA’s 

perspective. Health, you know, if you look at a patient’s journey or 

individual’s journey from a healthy living to care to management of their care, 

FDA has an expectation when it’s - it is a medical device, when it is used in a 

medical device, when the technology is used in the medical device, when its 

technology and advances are used to develop the medical product that’s 

manufacturing. And then the most important thing that we all are sort of very 

excited about is how technology can be used to study a medical product.

And last but not least is the emerging area where you’re seeing lot of 

companion and adjunct digital health technologies used with medical products 

that include diagnostic and therapeutics.
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On the next slide, you’ll see we’ll talk about why the Center of Excellence 

such an important thing for us to start thinking about. This is as Irene said, is 

part of the planned evolution for Digital Health Program. We want to drive 

synergy. We want to align strategy and implementation. And most 

importantly, we want to make sure that FDA and the community is prepared 

for the digital health future while protecting patients and maintaining our 

standards, our FDA standards of safety and effectiveness.

On the next slide, we’ll talk a little bit more about, so what is the goal? Our 

goal is to empower stakeholders like I said before. We want to foster 

responsible and high quality digital health technology innovation. We’re 

going to do that by connecting and building partnerships. We want to share 

knowledge and the Center of Excellence can help share that knowledge both 

internally and externally. And we want to sort of innovate in our regulatory 

approaches to become the regulatory innovation hub for FDA so we can keep 

up with this emerging field of technology that raises opportunity and issues 

that we need to get ahead of.

So that sort of drives sort of this whole concept of, if you innovate, connect 

and share we truly we believe that we’ll empower.

Through this discussion we will talk more about this topic, about what the 

goals and outcomes we want to see. And we’ll dive deeper into it.

On the next slide, you will see here are some of the outcomes we are 

anticipating. We want to advance science and evidence. As most of you 

already know evidence is an extremely important thing that sort of help us get 

that trust and confidence in these technologies. We want to also create a place 

within FDA that we can rely upon and get access to expertise and knowledge 
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in this space where the expertise is scarce. We want to make sure that we are 

aligned internationally as well.

And last but not the least we want to be consistent in application of our policy 

and (our outside) purchases while helping everyone at FDA trying to beat with

the same perspective on how technologies should be evaluated, looked at and 

what evidence we should consider.

On the next slide, we have been operating under the first four boxes here in 

technology and policy support. My group in Digital Health Division we’ve 

been working on strategic partnership initiative such as Pre-certification 

Program and we have continued to develop policies.

What we are going to do going forward with the Center of Excellence is we’re 

going to take the operations of the Center of Excellence and also house it 

within the group, hence providing this connecting place for people inside of 

FDA as well as people from - external to FDA to sort of get to the right 

people, right experts in the center in CDRH and FDA sooner and quickly.

On the next slide, so although this is a very, very small print on this slide, I 

just wanted highlight, very, very quickly the Center of Excellence is actually a 

virtual Center of Excellence, Virtual Center which allows things that are 

already happening within the Digital Health Group at FDA. But also allows 

connecting other aspects of digital health work that was going on across 

CDRH and across other parts of agency and making sure that we are 

synergized and aligned with the goals of digital health and the way we want to 

promote digital health to make sure that the issues, science and advancement 

happens in a very coordinated way.

On the next slide, you will see how we are thinking about moving forward.
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We - Irene can you go forward with the next slide, one more? Thank you.

What we want to do is make sure that those dedicated Center of Excellence 

resources and virtual resources are available to all within CDRH and all 

within FDA. We are going to set up an - a virtual group that will address and 

align our activities to the goals of the Center of Excellence. We would have a 

Steering Committee in the - at CDRH to provide policy, Horizon scanning and 

regulatory science agenda.

Within FDA we’ll continue to sort of work with an Advisory Group across all 

stakeholders within FDA to start aligning and synergizing in our approaches 

towards digital health. As you can imagine digital health is being embedded 

into a lot of other medical products that FDA regulates. It becomes a resource 

as we move forward for folks within FDA to start thinking and considering

and looking at expertise in this area from one stop - one place within FDA 

which is the Center of Excellence.

On the next slide, these are kind of the services we’re trying to offer to folks 

from various perspectives. Within CDRH you heard a lot about me talking 

about leading, building and coordinating. And within FDA we’ll - we have -

we will support, align and promote and amplify work that’s already happening 

in other parts of FDA ultimately to empower and externally. We want to 

partner, coordinate and then provide a voice to the work that’s already 

happening and be the bidirectional exchange within FDA and others that have 

been working in this area.

I’ll go a little bit deeper into each of these areas in the next couple seconds.
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On the next slide, within CDRH we will be leading and setting strategic 

direction for digital health. We’ll be launching strategic initiatives. You 

already seen some of the regulatory innovation that we are working on and 

we’ll continue to do that. We’ll continue to amplify work that’s happening 

and develop and coordinate cost-cutting digital health policies at CDRH.

For the next slide you will see and FDA will continue to support other centers. 

We’ll align and promote and amplify work that’s going on. We’ll find 

synergies and look for synergies where regulatory science exists, for example, 

and research in digital health can benefit all centers. We want to showcase 

just like we would showcase for CDRH, we want to showcase the work that’s 

happening in other areas, in other areas of FDA that can be highlighted, that 

with the goal towards empowering digital health stakeholders to take digital 

health to a safe and effective way.

On the next slide, for external stakeholders we want to continue to provide the 

clarity on regulation. We want to make sure that we are building strategic 

partnerships. And we’ll talk a little bit more about that collaboration.

And then we want to communicate our FDA list of interest. We want 

advancements to happen where patients are served, individuals are served and 

the healthcare is served in the best possible way.

And we want to do all we can within our powers, within our capacity to make 

sure that this field collectively gets to the next level with everybody leaning

forward.

On the next slide, you’ll start seeing some of the areas we’re going to start to 

focus on initially.
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And some of this you may already recognize, software as a medical device 

and software in a medical device are sort of something that we’ve been 

working on for a long time.

We also see other things such as, you know, virtual reality, digital biomarkers 

and other AI such as advanced manufacturing and advanced clinical studies. 

We want to make sure that we are focusing and promoting advanced 

manufacturing. We are focusing and promoting digital biomarkers that can be 

used and remove some of the redundancies in the space and make sure that 

advancements happen in a very coordinated way.

On the next slide, you will see our plan. I mean we put this out on our web 

site so most of you may have seen it. Today it’s a listening session. I won’t 

read the slide but I’ll tell you that our goal towards establishing the Center of 

Excellence and this is the beginning of our conversation. This is the very first 

listening session. We’ll continue to engage with all of you.

And as we move forward we want to communicate, communicate, 

communicate. We will be entering into coordination’s and building 

partnerships and then becoming that one stop as we talked about.

I think this is the end of my presentation. I’m going to turn the discussion 

over to the panel next.

But before I get to that, I want to give you a couple reminders. We are eager 

to hear from everyone today. Understood it’s a listening session but we’ll

focus on two topics. Topic number one is goals and outcomes of the Center of 

Excellence. And topic number two is collaboration.
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We’ll talk in detail about this in the next few minutes. But before I get going -

get started with that, I also want to remind everybody on the phone call today 

who are listening into this webinar and listening session to use the chat 

window to put your comments, feedback into the chat window in case we 

didn’t get to you to the voice.

After the panel discussion we’ll open the mic up for people to provide their 

perspectives and inputs as we move forward. And we’ll turn it over to you to 

provide that feedback.

But before we get - so let’s get started. I’m going to ask each panelist. The 

format for this panel is each panelist will provide a short perspective on the 

questions. And then we’ll open it up for listening sessions from the audience.

So let’s start with the first question for the panel. How would focusing those 

goals that I just shared in my presentation help meet the needs of the digital 

health stakeholders?

Let me start with everybody to give me a one minute perspective. So I’ll just 

go around the panel for a second. And we’ll start with Zach.

Zach Rothstein: Well thanks Bakul and thanks so much for your leadership on all these digital 

health issues and standing up the Center of Excellence. I know we’re very 

excited as an industry to see, you know, just how much this can bring to 

everybody’s ability to add clarity and other regulatory convergence in the 

space of digital health.

In terms of the goals that you’ve outlined for the center, you know, I think 

what will be really helpful for the regulated industry that is currently under 

FDA jurisdiction and is developing new and exciting digital health 
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technologies is the added regulatory clarity around what these products will be 

subject to at the FDA.

And then also the concept of international harmonization, you know, your 

leadership on the IMDRF CMB Working Group and ability to incorporate 

some of that activity into the U.S. FDA’s policies have been really helpful for 

companies that sell on a global level.

And I think as more and more digital health companies sell in more than one 

country, having that harmonized approach to digital health regulation will 

really be helpful.

Bakul Patel: Thank you, Zach. Let’s go to Rene, Megan and the Heidi and Bill after that.

Rene Quashie: Sure. Thanks Bakul. First, let me start off by saying that the new center 

really underscores the importance of digital health to CTA and so we 

commend you and your leadership for that.

In terms of looking and listening to the goals I think here at CTA we believe 

the center is going to help foster public/private partnerships which we think 

are incredibly important in some of these complex areas of digital health.

But also just as importantly create needed pathways for better communication 

between the agency and the wider stakeholder community. I think when you 

think about regulatory clarity, coordination and alignment we believe those 

are keys to moving the sector forward as development of digital health tool 

increases exponentially in the coming years as we all think it’s going to.
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So the most important thing here is alignment and coordination in terms of 

FDA’s regulatory approach and messaging regarding digital health which I 

think will then lead to greater clarity for the stakeholder community.

And thank you very much for the invitation to participate.

Bakul Patel: Thank you, Rene. Megan.

Megan Coder: Thank you. I would like to echo I think other’s commentaries here. But I 

think consistency and clarity are the two most important things that we see 

right now in terms of this particular issue in terms of looking at this from

across agency approach, it’s really great to see how NICE approached

developing even at the more specific review level of the different teams 

looking at these products.

I think it’ll be important for these teams to not only have consistency in how 

these products are reviewed across different divisions but then also the type of 

clinical studies and real-world evidence outcomes are expected from digital 

health technologies.

So as that is developed more broadly I think the industry will benefit from that 

clarity whether it’s healthcare decision makers or clinicians looking for ways 

to best assess these technologies or again more from the international 

approach of the harmonized idea of how digital therapeutics and other digital 

health technologies are really viewed, assessed and then authorized.

Bakul Patel: Thank you, Megan. Heidi and then Bill.

Heidi Dohse: Sure. Thank you, Bakul. From the patient perspective, the work that the 

Digital Health Center of Excellence is bringing is an engaged patient today 
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has access to potentially an implanted medical device, the consumer 

wearables and mobile Apps that are out there and available and then again 

environmental sensors.

And so patients have been leaning more on self-care and looking for insights 

that they can lean on to make decisions during their day and to improve their 

health and wellness, bringing the innovation that tech companies are bringing 

and aligning that with what the medical device and healthcare industry 

stakeholders have been doing.

And I think that this Center of Excellence will be a forum to share ideas, 

collaborate and bring all the stakeholders together for best practices and what 

other requirements that the patient community is looking for.

So I’m excited to see what’s possible and how the center can help make this 

happen.

Bakul Patel: Thank you, Heidi. Bill, do you want to add.

Bill Evans: Sure. First, thank you again, Bakul for this opportunity to talk to some of 

these things. You know we think at Rock Health about this in three parts. 

You know and as an investor in early stage startups, there’s a particular 

viewpoint and I share that just so everyone sort of knows where we’re coming 

from. I think about it in terms of what this does for producers of innovation in 

this space. These are early stage companies. I think it creates potentially much 

more predictable and plan performance.

And so for entrepreneurs and investors that means more insight into the 

capital needs of early innovation. The better insight everyone has, the faster 

innovation can go and the more efficiently from a capital point of view.
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And the secondary is consumers. And I think of consumers really in two 

groups. Individuals, of course you and me, everyone as an individual who 

might be out looking for something digital to help us with a problem but also 

institutions which actually comprise about 80%, 85% of the market for digital 

health innovation that’s delivered by startups.

And our market research has kind of shown that time and again. So I think 

actually giving institutions insight into when an FDA approval is appropriate 

and necessary versus not really clarifies the market in an area that is rapidly 

changing. And that’ll help a great deal.

And then the final is just competition. Creating a clear and level playing field 

will spur competition that aids consumers and allows the best innovation to 

succeed in a really streamlined way.

Bakul Patel: Thank you, Bill. Let’s dive a little bit deeper into that conversation a little bit 

and maybe I’ll ask a pointed question. You know what plays - a - stakeholder 

needs like looking at it from a different direction are not addressed by this - by 

the goals that we listed earlier?

Maybe I’ll have Bill and Rene to provide a short perspective on that. Bill, do 

you want to go first?

Bill Evans: Sure. Thanks, Bakul. And I sort of think about this in terms that aren’t so 

much that, you know, there aren’t - the needs that aren’t being met but needs 

might be met differentially right now and that the Center of Excellence has an 

opportunity to level things out a bit.
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And of course, you know, the perspective I have is that of big versus small or 

incumbent versus new entrant to the space.

And so today I think that there’s a great deal of advantage to having scale 

already in place. Having a regulatory apparatus built into your company 

requires that you’re already a pretty big player. Smaller companies have 

today or at least historically a harder time entering simply because they lack 

that infrastructure. They have to develop it and they have to do it or may have 

had to do it in a particular way.

I think with the Digital Health Center of Excellence and work that FDA has 

done frankly over the last couple of years already we’re starting to see the 

playing field level a bit more.

But I would say that that’s a stakeholder need that isn’t explicit in the goals. 

But it’s a potential byproduct.

Bakul Patel: Well thank you. How about you Rene?

Rene Quashie: Yes. I’ll amplify a little bit of what Bill said. So I think what I’m about to 

say is generally captured in the materials you presented particularly regarding 

amplifying FDA’s work and awareness. And I think it’s somewhat described 

in other materials that I’ve seen.

But I would like to specifically include specifically stakeholder education as a 

need. In particular, I’m talking about FDA stakeholder education 

organizations who don’t usually as a course of business deal with FDA given 

the products and solutions they develop but who are now dealing with the 

agency or are about to deal with the FDA as they develop health related 

solutions.
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And so I’ve heard from many such tech related stakeholders and I believe 

there is a lot of misunderstanding and misapprehension about FDA rules and 

processes. And demystifying some of this would be very productive.

You know we don’t need to get into implementation specifics. But I think 

something for example like the new Center of Excellence hosting a call every 

couple of months with a specific agenda perhaps around certain product 

categories could be an effective way of reaching and educating the 

stakeholders I’m talking about while also hearing their issues and concerns.

Bakul Patel: Great. I think that’s a great point I think that you both make. I’m going to 

give just if you guys can take like 15 to 20 seconds to see if you want to add 

anything to this. I’ll go with Zach first and then Megan.

Zach Rothstein: Yes. Thanks Bakul. You know I think for right now it seems that, you know, 

the issues that the larger regulated industry would have are pretty well defined 

within the slide deck that you presented.

But I think, you know, as Rene was alluding to, you know, any additional 

clarity and insights you can provide throughout, you know, the standing up of 

this center about how it will function and how stakeholders can leverage it 

will always be helpful.

Bakul Patel: Great. Megan what about you?

Megan Coder: I’ll jump in. Yes. I think building on Rene’s comments also I really liked his 

notion there. And I think my addition would be more from that clinician side. 

I recognize and appreciate that clinicians are part of this discussion.
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But we keep getting questions around well what’s the difference between 

clear versus or approved or prescribe versus authorized or 510(k) versus De 

Novo and forcing discretion versus something different.

So that clarity too is going to be really critical I think for clinicians and those 

writing guidelines or other decision makers helping them understand oh, this 

is the corollary to what we’re familiar with and this is how we can best engage 

with this new category of medicine be it any from these digital health 

technologies.

Bakul Patel: Great. Thank you, Megan. Heidi before we go to you, and I’ll pose a slightly 

separate question and this may be very much a patient focus, right. So what 

do you see as benefits of these anticipated outcomes that we have listed in my 

talk for patients and consumers though are not, you know, necessarily labeled 

as patients? Heidi.

Heidi Dohse: Yes.

Bakul Patel: Do you have a perspective on that?

Heidi Dohse: I do. The benefits that this, you know, new Digital Health Center of 

Excellence brings to the patient and consumer community is really it’s 

formalizing many of the things that the patients have been doing by 

themselves. You know, consumer technologies, consumer wearables and 

mobile Apps have been available. You know, like the last five years there’s 

really been a lot of innovation. In the last two years these products have 

become, you know, bumped up against the almost medical grade in the data 

insights that are produced.
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But the benefits now with what the FDA is spearheading through the Center 

of Excellence is to actually formalize what do data insights mean, how can 

patients use them, what does it mean for compliance safety and effectiveness 

and to have those standards. Because when we have, you know, have that 

information that then gives us a path for how that consumer generated or 

patient generated data and information can be moved into our medical records 

and our medical healthcare conversations with our physicians.

So I think this is just going to give us that pathway of unifying what’s 

happening in the consumer/patient available world and traditional healthcare.

Bakul Patel: Oh thank you Heidi. Megan, do you want to add to that?

Megan Coder: I think...

Bakul Patel: From a patient’s perspective. Yes.

Megan Coder: I think she had it really well said. I think from the patient perspective too, I 

can’t pretend to speak for the number of patients that exist across the spectrum 

of different diseases and disorders, the technology types.

So even what patients are dealing with on a day-to-day basis is going to be so 

unique. And how though we can start create some more categorizations and 

help them understand how my data is being protected, what data am I giving 

over, how does this translate into these meaningful actions, what is actionable, 

all of those questions I think will be very helpful for us as an industry 

alongside the agency and other stakeholders to really start to hash some of 

those out.
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Bakul Patel: Well thanks Megan. We’re seeing a lot of good feedback coming in on the 

Q&A. And we’ll touch on those real quick.

So Zach and I know Rene specifically and Bill, as you guys are also seeing 

sort of patient benefits eventually sort of result from digital health and what 

perspectives do you have on the outcomes of the Center of Excellence?

Zach Rothstein: This is Zach. And I think, you know, before you used the word upfront about 

empowering all different stakeholders. And I think in particular the patients 

here will be the ones that benefit a lot from having their own ability to manage 

more of their own health and their data through these tools.

And I think that will come from the ability for all different types of 

manufacturers and software developers to create regulated medical devices in 

a more efficient and effective manner because of the way that FDA is putting 

together their policy.

So I think that word empowerment really rings true I think across the 

spectrum but in particular for patients.

Bakul Patel: Great. Bill, from your perspective.

Bill Evans: Yes. I agree with what’s been said. I would add the word transparency. I 

think that giving everyone in industry as well as consumers transparency into 

first definitions. What is digital health?

And FDA has been extraordinarily helpful and crystalizing what the 

subgroups of digital health products might be, what’s - increasingly what’s 

regulated and how to the extent the CoE does two things. It first continues 
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that trajectory of helping industry. All stakeholders categorize clearly what’s 

digital health and how each group gets regulated.

And second, really an understanding of how to pursue in the regulated space 

approval. And then there’s a number of things to answer and address still 

within that.

But I think that I’m really excited that that transparency is - the CoE is going 

to really provide that transparency.

Bakul Patel: Okay.

Megan Coder: Can I actually jump in with one more comment on that one? I think...

Bakul Patel: Sure.

Megan Coder: ...that comment is really important. And looking at this idea of I think among 

patients it’s fairly common knowledge among patients that not all tablets and 

pills that come in the same color, like blue, they don’t necessarily serve the 

same purposes. Obviously medications are for a function, purpose and so 

forth. I think that notion of digital health technologies, yes, it may look like a 

digital product but what is its functionality, what is its purpose between 

adherence, fitness, telehealth, remote monitoring and so forth.

So I think all of those are really important just to build upon what was just 

stated looking at the education is really important for patients to understand 

what they’re using but then also why they’re using it too.

Bakul Patel: Yes, perfect. And if nobody had any other on this topic, any additional 

thoughts, I wanted to see if...
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Rene Quashie: Yes.

Bakul Patel: Go ahead.

Rene Quashie: Yes. Bakul real quick, the only thing I would add to everything that’s been 

said that sometimes when you talk about consumers we think about patients 

but I think it’s important to remember the provider community as well 

because there’s a lot of...

Bakul Patel: Yes.

Rene Quashie: ...confusion and misunderstanding regarding the efficacy of digital health 

tools within the provider community.

Bakul Patel: Yes. And that’s a great point Rene. I think that’s a great add. There are a 

few questions coming in or actually perspectives coming in. People are like 

wondering about, you know, reimbursement. I think that’s one thing that 

definitely, you know, FDA does not do that. But I think we can have a good 

linkage.

You know and maybe taking a small step back and Jeff, turning over to you, 

we heard the panelists sort of give their perspectives. And we’ve seen some 

of the feedback that we’ve been seeing coming in through the chat window.

From a public health and FDA perspective, how would these outcomes align 

with, you know, sort of the goal of advancing and empowering digital health? 

Can you give us your thought?
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Jeff Shuren: Certainly and I’ve been furiously taking notes so I’m also going to try to 

synthesize a lot of the things that I heard. And so kind of taking a step back, I 

think it all comes down to meeting patient and consumer needs, improving 

their health and their quality of life.

And, you know, patients and consumers should have digital health 

technologies that meet their needs and that they can rely on.

So to accomplish that, patients, consumers, and providers need an FDA that 

empowers and educates them, actively listens to, understands and incorporates 

their voice. And developers need an FDA that understands and advances and 

moving science and engage with developers and other stakeholders to provide 

advice proactively, not just feedback and problem solve in real time and offers 

predictable, transparent, consistent, robust but appropriately tailored 

regulatory pathways that optimally are globally harmonized.

And that ultimately the Digital Health Center of Excellence can serve as a 

leader, a facilitator, an educator, an innovator and a catalyst to help 

accomplish these goals, meet these needs and achieve these outcomes.

And I think the outcomes all align through the taking of a holistic approach to 

digital health technologies that would allow all of us to turn the total product 

lifecycle into a virtuous cycle.

Bakul Patel: Thank you. Thank you, Jeff. That’s really nicely, like pulled together.

I think we have a few minutes for this particular panel to sort of or this topic 

to sort of continue the discussion.
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But I think Irene and the Operator if you can open for audience to ask - add 

their perspectives it’ll be great on the topic we were just talking about.

Irene Aihie: Sure thing Bakul. (Chelsea), can you open the line for potential questions or 

perspectives?

Coordinator: Will do. For comments and questions please press star then 1, unmute your 

phone and record your name clearly when prompted. If you’d like to 

withdraw your comment or question press star 2; one moment while we wait 

on our first comment.

Irene Aihie: Bakul, it looks like we have a few comments coming in.

Bakul Patel: Okay great.

Coordinator: The first participant in the queue is (Paige Griddik). Your line is now open.

(Paige Griddik): Ah yes, can you hear me?

Bakul Patel: Yes, we can.

Irene Aihie: Yes, we can hear you.

(Paige Griddik): Excellent. And thank you so much for this presentation. So I also placed this 

question in the chat. In Europe we have GDPR and in California CCPA.

Is this Digital Health Center of Excellence a place where FDA might discuss 

with stakeholders their approach to a data protection regulation?
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Bakul Patel: Maybe I’ll take that first and since it’s a question. I think we’re building this. 

And I think FDA has its boundaries I would say. And, you know, we can talk 

about it from a safety perspective and effectiveness perspective. Of course, 

data becomes an important aspect in digital health world and digital world.

I think protection of data at the same time, the liquidity of that same data for 

evidence generation is going to be really important and a balance would need 

to be struck.

And I would be open to looking at ways to work with stakeholders to find that 

right balance.

(Paige Griddik): Thank you so much.

Coordinator: The next participant in the queue is Dr. (Hokayen). Your line is now open.

(Hokayen): Hello everybody. Thank you so much for this very, very, very interesting first 

listening session. I’m looking forward for the rest of the sessions as well and 

for this roadmap that Bakul has delineated for the Center of Excellence, with 

Digital Health Center of Excellence.

I would say thank you for everybody and thank you to Bakul and his team for 

making this happen.

I’ve been personally involved in clinical trials for digital therapeutics and 

digital diagnostics. I’ve been involved in digital health for the past four years. 

I know it’s a nascent field and things are not pretty clear about it. Obviously, 

everyone’s trying to apply common sense, right.
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But at the end of the day we would need guidance and certain regulations to, 

you know, to be clearer than they are today, you know, to guide everybody.

And here’s based on this perspective, I have a question to Bakul and to the 

panel as well about any perspective on the role of the CoE and establishing the 

regulatory roadmap to getting those products like digital therapeutics 

especially to the market especially regarding clinical trial requirements.

What would we as clinical research organization, I mean how do you envision 

the clinical research organization would be interacting with your Center of 

Excellence so that we can basically give the right advice, design the right 

trials if needed obviously, and understand better the regulatory roadmap for

this?

Bakul Patel: Yes. Does anybody on the panel want to take that?

Megan Coder: I’ll let you go with that one Bakul first. I’d be interested to hear the 

regulatory side of the question. But I really admire the question in terms of 

the digital therapeutic perspective and the types of clinical trials, the type of 

endpoints, control arms. How do trial designs [for DTx] differ from other 

types of [designs for] either traditional devices or traditional medications or 

therapies?

So these are all questions that we in the industry are looking at. But in terms 

of the FDA’s action I wouldn’t want to speak on your behalf either.

Bakul Patel: Thank you, Megan. Look, I think we have to be honest. I think that as we see 

new therapies and digital therapeutics that have been merged and we’re seeing 

use of digital technologies in the clinical trials, we also have a lot of questions. 
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A lot of - have redundancies that are going on. People validate tools over and 

over again for their own intended uses.

I think one of the things we would love to sort of see work, the industry and us 

to be participating in that activity would be is setting standards. I think this is 

where, you know, folks like Consumer Technology Association and you, 

Megan, can come in and start thinking about what should that start to shape 

up.

And I think the regulatory requirements obviously will have to be an input to 

that discussion. But I think that initial first common sense, you know, this is 

what the stakeholders need for the trust and assurance is initially get started.

And I think that’s going to be, you know, I think about that as a best practice 

kind of evolution that we need to work towards together.

(Hokayen): And are you open to - obviously I’ve paid attention to the emphasis on 

communication, right, especially in this...

Bakul Patel: Yes.

(Hokayen): ...period right now. Would you be open to talking with several stakeholders 

in the clinical research organization world so that, you know, we could at least 

have our voice heard and, you know, our concerns addressed in terms of, you 

know, the context that I just explained in terms of clinical trial requirements 

and regulatory roadmap for digital therapeutics and diagnostics?

Bakul Patel: Yes. What I’m taking away from your question is one thing is collaboration. 

We need to...
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(Hokayen): Absolutely.

Bakul Patel: We need to work towards that mechanism of collaboration. And I think that’s 

the next topic we’re going to talk into the next few minutes.

But that’s exactly the point is what areas we need to collaborate on. I’m 

hearing research and studying medical products is going to be one of the 

biggest areas that I’m hearing that’s important.

And then finding mechanisms to work with within our bounds of what’s 

allowed for FDA to participate in is going to be something that we have to 

explore.

And absolutely, I would want to make sure that we are working to helping or 

helping our stakeholders, that includes you and include stakeholders who are 

researching in addition to the providers that we can start building that, you 

know, infrastructure in place. So absolutely, I would be - or agree with that.

(Hokayen): Wonderful, wonderful.

Jeff Shuren: And this is Jeff.

(Hokayen): I can’t thank you all enough really.

Jeff Shuren: Oh and I was just going to add.

Bakul Patel: Yes.

Jeff Shuren: You know that role around “clinical trials” things may change over time as we 

revisit on regulatory paradigms. You know if we move away from the current 
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sort of stage gate approach and traditional clinical trials and we really build 

much more of a learning model through the total product lifecycle. And we’re 

going to be thinking about the generation. Really the way I’d focus is 

generation of clinical evidence a bit different.

Bakul Patel: Yes, great point. Good point there Jeff.

(Hokayen): Absolutely.

Bakul Patel: Irene, I think we’re getting up to our time for the next topic. We’ll take one 

last comment or question before we go onto the collaboration topic.

Irene Aihie: Thanks, Bakul.

Coordinator: The next participant in queue is (Jeanine Moore). Your line is now open.

(Jeanine Moore): Thank you. Bakul, Jeff, I really appreciate all the efforts you’ve been putting 

into developing a coherent digital health policy.

Coming from a pharma company one of our concerns has been the 

inconsistency across the centers. And I was curious to know how the Center 

of Excellence will help better coordinate more harmonized policies given that 

the Center of Excellence for Digital Health is not reporting up to the 

commissioner but to you, Jeff.

So what types of strategies are you thinking about so that we are better 

harmonized across each of the centers?

Jeff Shuren: Yes. That’s a great question. And I think, you know, in Bakul’s presentation 

he talked about some mechanisms for having a much more fluid engagement 
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across the FDA on these issues, one of them being the creation of that sort of 

Advisory Group within the FDA for the Center of Excellence.

And I think it’s through those mechanisms that we as an agency are going to 

progressively move forward in lock step. Even though we may be dealing 

with, you know, somewhat different concerns and issues, the opportunity to be 

far more consistent and harmonized is going to occur as this becomes more of 

a routine day-to-day activity.

And that’s one of the exciting roles that the Center of Excellence is going to 

play.

(Jeanine Moore): Thank you. And so is there an opportunity for the industry to communicate 

with that committee or is that through your internal mechanism?

Jeff Shuren: I think that’s some...

Bakul Patel: I...

Jeff Shuren: That’s, you know, a really great point that I - well I’ll let Bakul jump in too. 

But that is something we should have a discussion around those opportunities 

to have much more fluid and broader interactions across the FDA.

Bakul Patel: Yes. I was going to just add.

(Jeanine Moore): Yes because...

Bakul Patel: Say exactly that, Jeff. And (Jeanine) I think your point is right. I think in 

addition to having communications and input and bidirectional channels of 

information flowing back and forth for the Center of Excellence, I think that’s 
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equally important to think about how that group and/or the Center of 

Excellence can engage with, you know, folks external to that group.

So to be defined, I think, you know, this is the beginning of the conversation. 

And we’ll continue to sort of explore best ways and mechanisms to set that 

up. And I think the need is there obviously.

(Jeanine Moore): Yes, right. The need is definitely there because we’re having this increasing 

convergence of digital technology blending with drug development. And you, 

CDRH has made a very cogent and coherent policy.

But when we interact with the other centers basically it stops with CDRH. 

Even when we’re developing our own medical devices it doesn’t seem to 

apply.

So I think there needs to be some more engagement and discussion to try to 

understand where our barriers are. So I’m happy to participate in any of those 

conversation if the opportunity arises.

Bakul Patel: Absolutely. No. Thank you. Thank you, (Jeanine). Why don’t we move 

onto our next topic of discussion which is kind of heading in the conversations 

around - revolving around collaboration?

And without, you know, getting down into the details of, you know, what it is, 

and how we exactly do it at this minute, you know, Jeff I’m going to turn to 

you and just have you share your thoughts. We’ve been - CDRH has been and 

FDA in general has been, you know, collaborating with stakeholders all along. 

I mean FDA I know we have engagement with standards community. We 

have engagements in the public/private partnership. We also have a program 

on collaborative communities.
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What can we do as an agency and what can we not do as an agency? Can you 

just set the stage for us so we can have the next segment of our conversation a 

little bit focus and give people an idea of our limitations and our opportunity?

Jeff Shuren: Well CDRH, I mean we will do what we have the resources to do. But there’s 

always going to be more that can be done. So what we shouldn’t do is 

overextend ourselves, instead be strategic.

One off collaborations can be and they will continue to be important 

particularly when they involve multiple stakeholders. We tend to get more 

bang for the buck with public/private partnerships. They can be a force 

multiplier because they allow a range of stakeholders and depending upon the 

partnership to share human, financial data, intellectual resources, as well as 

provide efficiencies for undertaking particular projects and work streams such 

as through existing contracts.

And we believe the same greater bang for the buck will hold true and 

hopefully even more so for collaborative communities which is something 

that’s a strategic priority for us that we’ve been now pushing for the past few 

years that really is a very different approach on collaboration at least for 

government where instead of government being command and control and 

then bringing in partners, instead it’s the community that really takes charge 

in solving shared problems, achieving shared outcomes and government has a 

seat at the table. We’re just a member of the community. And we kind of 

view it as truly emblematic of what representative government.

And now several have been established and we have signed onto to be

participants. And it’s my hope we’re going to see more of this collaborative 

community approach merge in the digital health space.
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And then I think overall as we take advantage of what you get in the digitized 

space and that’s our opportunity for engagement in a much more fluid real 

time fashion.

So I think collaboration is going to start to change when we move to these 

models like collaborative communities.

But I also think the experience and the interactions are going to change too as 

we take advantage of the very technologies that we’re helping to facilitate 

come to the marketplace.

Bakul Patel: Right. Thank you. Thank you, Jeff. I think that sets the stage nicely.

I’m going to split the next conversation into two parts. The first part is, you 

know, what are the areas and topics that we should be collaborating on.

And I’m going to turn to Bill, Heidi and Rene. And then, you know, turn the 

next topic is like okay how can we do this.

So I think (Jeanine) and others who sort of commented earlier started that 

conversation already.

So, you know, Bill I know you may have to drop off to catch a flight. But, 

you know, are there topics that you would consider that, you know, that would 

benefit the advancement of digital health in short-term and/or in the shortterm that we should be taking on?

And maybe you can even highlight any long-term ones that you may have. So 

Bill, can you share your perspective?
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Bill Evans: Sure. Yes. So I think that there’s so much that’s been put in place in the last 

few or several years ago by Congress that, you know, is in implementation. 

But so my theme is here there’s still more to do in terms of implementing the 

guidelines that as I understand it were put in place by the Cures Act for 

example.

And so I think sort of thing of three areas around this, Bakul, you know, a first 

might be or no particular, you know, the new regulatory framework around AI 

and ML, and software as a med device. I think is extraordinarily helpful. I 

think there’s more work to be done there. I think that innovators in that space 

are - have seen a lot of change in a positive direction but still more to be done.

The second would be and again guidance around wellness versus regulated 

Apps has been really helpful especially in recent months. I think there’s still 

more work to do there as well to help put a clearer line in some cases between 

what’s wellness and not regulated by FDA versus what software fits clearly 

within FDA guideline - clearance.

And then the third would be more broadly sort of in pre-cert, you know, I 

think are the companies that we interact with are really intrigued and excited 

about it. I think one of the things that they want to know most would be what 

are the sort of quality and operational excellence standards for pre-cert and 

how can they be sure that they’re adhering to those? You know, nuts and 

bolts type stuff like is ISO-13485 going to get them that gold star or a CE

mark that aligns with IMDRF and some other things.

So they’re looking for - now they understand what the framework entails, 

they’re looking for some really clear signals about how to proceed.
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Bakul Patel: And that’s helpful. Heidi from your perspective, what would you say the top 

things we should do on topic areas for collaboration?

Heidi Dohse: So I think there’s two areas that I see that could be beneficial for 

collaboration. One is looking at how digital health technologies and 

innovation is going to enable new channels for both healthcare and wellness 

delivery.

And I think we’re going to see quite a bit of this in retail delivery of 

healthcare and wellness. So we’re starting to see more retail stores and things 

like that having like a Minute Clinic or, you know, a place where a person can 

come in, shop for groceries and go get some, you know, healthcare guidance.

So how do - you know, digital health and digital health insights are going to 

make that possible. How do we bring that into the conversation?

And then the other area is looking at other communities that have been 

leveraging what we’re calling digital health but as, you know, in ways that can 

share best practices.

And in this I mean in addition to being a patient, I’ve been an athlete for many 

years. And so I look at how I’ve been using my wearable devices for 

performance insights and my mobile Apps and how I communicate and work 

with my coach to reach performance goals. Much of that is very similar to 

how we as patients want to be able to have insights collected during our day 

and have specific data points that we can then better communicate with our 

physicians.
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So bringing in some of those lessons learned and how we can, you know, 

really improve and streamline the patient provider communication leveraging 

digital health solutions.

Bakul Patel: That’s really helpful. Rene, do you want to add anything there?

Rene Quashie: Yes. Yes, real quick. So CTA is ANSI accredited organization meaning we 

can develop voluntary standards much like other organizations such as UL. 

So we really believe that the importance of developing industry standards. 

One of my colleagues always talks about standardization for innovation, 

meaning that standards actually promote innovation.

So for us at CTA I think there are many issues for potential collaboration 

particularly on the standard side. But the two that jump immediately to mind 

are AI/ML, and digital therapeutics for many of the same reasons. First, we’re 

seeing tremendous development in both those areas.

Second, both those areas are showing great promise to positively impact 

healthcare.

The third, however, both areas also implicate many important regulatory and 

policy issues.

But the good news is there are many serious existing industry efforts 

underway to address these issues. So I think it would be relatively easy for 

the new center to engage with these efforts and provide better opportunity for 

public and private partnerships and collaborations you discussed, Bakul, but 

particularly focus on these I would call really truly emerging areas.
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Bakul Patel: Yes. That’s really important sort of that you pointed out that, you know, 

where the emerging spaces are actually trying to create new questions. And I 

think the collaboration makes a lot more sense.

Zach, and from your perspective, and Megan.

Zach Rothstein: Yes. I think Rene did a nice job highlighting two of the major themes that are 

kind of new to the industry. But I would still add clinical decision support as 

another item that we can further advance.

And in particular what I envision based on your slides today, Bakul, that the 

Center of Excellence might be able to assist with is two things. One is in 

terms of AI, ML and CDS, coordinating more with for example the Center for 

Drugs. And a lot of those tools are used both they might be regulated as a 

device but they also might have some drug implications involved with them.

The other part of it is the patients and the caregivers. And having those 

stakeholders involved in some decision making and policy setting around 

these types of technologies. I really think, you know, having all of those 

various stakeholders at the table will make for better policy and add trust and 

value to the entire ecosystem.

Bakul Patel: Makes sense. Yes. Megan.

Megan Coder: Yes. I think Bakul, all that you and Jeff have done even leading up to the 

center has been incredible, like you have been so open and welcoming of all 

these discussions. And for your willingness to learn has been appreciated.

And I think that with the center it could move us now more from this 

information gathering phase into more of an action oriented approach. So 
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looking I think at real-world evidence as another example here, digital 

therapeutics example can generate incredible amounts of data and a large 

variety.

But what data should be specifically generated for a regulatory purpose versus 

healthcare payer purpose or an academic purpose. How should available 

data be translated into real-world evidence that’s formally recognizable?

All of these ideas I think will cut across many of your areas of focus that you 

laid out earlier today and really bring greater clarity.

So I think this is an exciting opportunity where we can go from great 

discussions and great insights into this action oriented let’s move on some of 

these and then obviously looking at the international perspective. I’ll hold off 

on some more commentary there.

But I think there’s a lot that we could do and taking some of the existing 

frameworks right now for drugs and hardware and identifying how could 

those be adjusted and modified to really fit the needs and purposes of digital 

health and therapeutic products.

Bakul Patel: Yes. No. Thank you. Thank you, Megan. Why don’t we just, you know 

let’s dive one level deeper and then just talk about, you know, Jeff laid out, 

you know, best way to collaborate is, you know, in the collaborative 

community space and in a model. And there are standards activities that we 

get engaged in.

Are there - what do you guys think about, I’m looking at the panel and saying, 

you know, for Zach, what other mechanisms that may be existing out there 

that you think that we could engage in? Of course we can’t stretch our focus 
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in from the Center of Excellence perspective or FDA perspective. So where 

do we get our best bang for our buck and where do we sort of bring together 

the right level - right, you know, type of stakeholders together so we can have 

this robust conversation and solve problems together?

So Zach, do you have ideas and thoughts that you could share?

Zach Rothstein: Yes. Thanks. Thanks Bakul and it’s so good to hear that FDA is thinking 

about this question. You know I think doing these types of stakeholder calls 

and updates with an interactive Q&A with the - with anybody who wants to 

participate is a really good process to have that type of collaboration with the 

various stakeholders.

And I would encourage FDA to periodically host more of these sessions with 

updates and new learnings that you might have.

Bakul, you and the team that you lead at FDA is very, very active in the 

community. And we all see you at various industry events. And I would 

encourage you and your team to continue participating to the extent you’re 

able to and maybe now it’s even easier because so much is virtual but to 

continue to participate in those industry events.

But ultimately, you know, I think FDA is the strongest convener of any of the 

groups that are on this panel. I mean you have the power and the draw to 

bring all the various stakeholders under one roof.

And so whether it’s more calls like this with open Q&A, whether when 

eventually we can get back to the great room at FDA’s campus and have 

maybe in-person meetings and breakouts, I think, you know, you have done 
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this in the past with other topics around digital health. And I would just 

encourage that you continue to do that with the center.

Bakul Patel: Okay. Well thanks Zach. Megan, do you - what thoughts do you have? I 

know, you know, Digital Therapeutics Alliance is, you know, new and young. 

So how do you think about this?

Megan Coder: Hey. I know. We celebrate our third anniversary in five days. But that said, I 

think one area that I have been intrigued by. And Bakul this comes back to a 

panel that you and I did a while back with NICE from the UK.

And I love the idea of bringing together groups such as the FDA with other 

international agencies. And I think the IMDRF which I know you, Bakul, 

have been very involved in is a really critical group here.

And the type of work item that IMDRF had looked at including software as a 

medical device and others now looking at security AI, ML and so forth are 

going to be really critical.

And given the propensity of digital health products to be used in a crossjurisdictional manner, having these types of frameworks be it building off of 

the MDSAP Program of looking at how pre-cert or how other aspects of these 

different definitions of digital health technologies are coming into play here, 

how those could be incorporated and looked at from a multijurisdictional 

approach.

Echoing based upon Zach’s comments. You have been really at the center of 

lobby discussions. A lot of eyes are on the FDA. So if there’s a way that we 

could have a multiagency collaboration which has already been established 

we, as the Digital Therapeutics Alliance, and I’m sure many other agencies, 
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associations, organizations, would really appreciate ongoing international 

leadership in this regard.

Bakul Patel: Yes. No. Thanks Megan. I don’t know. Bill, if you’re still on, do you have 

anything else to add to it? I know you may have dropped off.

Bill Evans: Still here, still here.

Bakul Patel: Okay.

Bill Evans: And I will add one other thing and it’s parallel review. And I’ll echo 

everything the others said, yes to those things. I think parallel review with 

CMS has the potential to reduce the costs of innovation in a pretty substantial 

way by virtue of enabling an innovator whether at a large company or 

certainly at an entrepreneur and a small company to make a single investment 

or a package of investments in evidence generation that is both clinical in 

nature for safety and efficacy. But also economic in nature that demonstrates 

the outcomes that a payer, like CMS, is going to want to see.

That parallel review has of course the potential to get through a CMS 

reimbursement at the same time as an FDA clearance or approval. But it also 

will signal. It has this other benefit with a spillover that it signals to the 

private payer market a willingness to pay that accelerates adoption with 

consumers when reimbursement through payers is necessary. I think parallel 

review is the short answer for me.

Bakul Patel: Perfect. Yes. No. Thanks. Thank you. Others, do you want to add a few? I 

won’t call anymore and before we go to an open audience or a question, 

anything else anybody wants to add?
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Heidi Dohse: Sure. This is Heidi. You know prior to my jumping in and focusing full-time 

on patient advocacy, I come from the tech industry. And I just think that 

there’s such a great opportunity for the Digital Health Center of Excellence to, 

you know be that forum where you bring tech and healthcare together to really 

learn the - to kind of work together on the same timelines. And understand 

each other’s business processes, regulation and compliance so we can really 

bring this innovation more quickly to market with the understanding of, you 

know, how a tech company will bring something to healthcare and how 

healthcare can develop requirements in a timeline that can be executed by, 

you know, the digital health companies.

So I just feel like this is going to be a great opportunity to bring all the 

stakeholders together, learn the same language and really innovate in a 

collaborative way.

Bakul Patel: Yes. That makes complete sense. Why don’t we - Irene, can we open up the 

lines for people to provide their comments and perspectives? I think this has 

been a robust discussion. And I like to hear from the audience as well.

Irene Aihie: Sure thing. (Chelsea), could you please open the line for our participants?

Coordinator: Will do. As a reminder, for comments and questions please press star then 1, 

unmute your phone and record your name clearly when prompted; one 

moment while we wait on our next comment or question.

Bakul Patel: Okay. Well while we’re waiting for the next commenter to get in the queue, 

Rene did you have anything to add?

Rene Quashie: No. I echo everything everybody said. I’m wondering whether or not given 

what Jeff said about the FDA, the new center cannot be everywhere, if there is 
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any value in the center developing some criteria for how it will become 

involved in more formal industry efforts. Sort of building a framework 

around the efforts it is more likely to engage in. That also could be very 

useful for the center in sort of eliminating other industry efforts that may not 

be worth its time at the moment. And focus on sort of more mature or 

ongoing efforts.

Megan Coder: Well even the link established between those.

Bakul Patel: That’s a great, great point. Yes.

Megan Coder: Yes. I like that Rene. I think there’s value in the divide and conquer but 

making sure there’s harmonization amongst that process is going to...

Rene Quashie: Yes.

Megan Coder: ...be really important so we can all know where we need to head but heading 

there together. Given how aligned we all have been on today’s call I really 

support what you just shared there.

Bakul Patel: Yes. I like the suggestion. Perfect. Do we have anybody on the line?

Coordinator: The first participant in the queue is (Sandy Radusky). Your line is now open.

(Sandy Radusky): Hello everyone. Thank you for the very interesting presentation. I’m a 

Medical Officer in CBER.

And since we’re talking about collaboration will there be any opportunities for 

reviewers to offer ideas for consideration to be developed for digital health?
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There’s a lot of times when I’m reviewing files that I, you know, I have ideas 

that I think would be really helpful to clinical trials. And I just wondered if 

there was any way to do that.

Bakul Patel: Absolutely. I think the question and (Sandy), thank you for asking that 

question. Think - I think the panel will be very thrilled to sort of hear that, 

you know, just like people outside of FDA are interested in collaborating I 

think people inside of FDA just like the fact that you had raised this question 

is going to be really important for the Center of Excellence to sort of be that 

conduit and that enabler to make that conversation happen.

So we’ll continue to do that. Yes, there will be a mechanism. And I will 

actually since you’re within FDA and with - and at CBER we would probably 

work with you all to understand how best to sort of do so and know what ideas 

you have and communicate that and provide a platform for that so absolutely.

(Sandy Radusky): Thank you.

Coordinator: The next participant in the queue is (Scott Robertson). Your line is now open.

(Scott Robertson):Hello. Yes, and agree, very nice presentation. Thank you for this 

opportunity.

One thing it was briefly mentioned by one of the panelists, there’s sort of a 

connection point that needs to happen that’s not really been discussed a lot 

because some of these digital therapeutics are going to be things that, you 

know, the simple things that augment already existing therapeutics that can be 

done independently. Patients just can download an App or something that 

then assists in their therapy.
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But there’s going to be a lot that are going to need to be coordinated through a 

healthcare provider.

So connecting the provider who knows some degree of that and the patient, I 

would like to suggest that the pharmacy can play an important role sort of as a 

coordinator. They don’t need to know the details but they can be a conduit 

both for an extension of the prescription concept, you know, this is the 

application they need, and the pharmacy can help the patient get it together or 

connect them with specific resources from the manufacturer.

I will admit that I do this somewhat self-servingly since way back when I was 

a practicing pharmacist but now I’m much more into standards and 

technology. But just offering as a point of that last connection point to get 

from healthcare providers to the patients is a comfortable environment for the 

patients typically in pharmacies.

Bakul Patel: Absolutely. Thank you so much for that comment. I will definitely keep that 

in mind as well and that’s a great next topic to think about; other comments.

Coordinator: The next participant in the queue is (Val Vanicure). Your line is now open.

(Val Vanicure): Hello. Hi. As a CEO of a digital therapeutics company I was wondering how 

the FDA is planning to work with for example CMS around reimbursement 

codes especially in the field of digital health, digital therapeutic solutions.

Bakul Patel: Yes. I think Bill brought this up, right. Parallel review is one of the programs 

that we have that focus towards evidence, right. And I think Bill, you may 

have some thoughts and Jeff, you may have some thoughts on this too if you 

guys want to just chime in here on reimbursement portions of FDA’s role.
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Megan Coder: If I may even just jump in, this is Megan. I think one thing with the MCIT bill 

proposal from CMS, the Medicare Coverage of Innovative Technologies, 

there is the opportunity for CMS propose that any product with a 

breakthrough status could receive four years of reimbursement through CMS.

That said from the digital therapeutic side, my understanding is that unless 

you have a benefit category this is not applicable to you so therefore digital 

therapeutics may not benefit directly from this.

But I will turn over to Jeff and Bill who may have just been jumping in also.

(Val Vanicure): Thanks.

Jeff Shuren: Now these are great points. And we have - look, we have a great relationship 

with CMS. We have had active discussions on a variety of areas including 

around, you know, coding which I think we all know can be, if there isn’t 

timely and appropriate coding tied to appropriate levels of reimbursement, it 

can be a barrier to innovation.

And the second piece of course is predictability around reimbursement. You 

know as Bill raised parallel review, certainly one mechanism not just with 

CMS but we’ve opened it up for other interested payers including private 

payers.

And say, of course, if you meet the criteria is terrific because it provides high 

level of predictability and, you know, love to see continued innovations like 

that from CMS. You know there’s interesting work stream going on in the 

Medical Device Innovation Consortium, one of the public/private partnerships 

we’re in. That is around a number of issues linked to reimbursement.
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And they just brought in very excitingly Jo Carol Hiatt who used to be with 

Kaiser to help lead that effort. And that is also an opportunity for some 

alignments between FDA, CMS, developer community and others.

Lastly I’ll throw in here is real-world evidence. I think was brought up earlier 

in its role with payment.

And I think to the extent that there are efforts that sort of facilitate the 

generation, efficient generation around real-world evidence, it’s just not fit for 

purpose from a regulatory standpoint but it’s fit for purpose to then meet 

coverage, you know, payer needs, to meet those of also informing decisions 

by patients, consumers, providers, will get us a long way and that’s why I’m 

excited about our engagement in efforts like NEST and related activities.

Bakul Patel: Great.

(Val Vanicure): Thank you. Thank you so much. It’s very helpful. Thank you.

Bakul Patel: Now we’ll take the next comment.

Coordinator: The next participant in the queue is (Jeff Tackle). Your line is now open.

(Jeff Tackle): Hi and good morning. Thanks for putting this session together. I think it’s 

really exciting turning point in the development of digital health and really 

exciting.

I wanted to kind of follow-up too from Rock Health (unintelligible). So I 

work in the third venture-backed (unintelligible) years. And I think one of the 

things that’s most - I’m most optimistic about it is that (unintelligible) there, 
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you know, and maybe through that enabling a bunch of startups to build with 

greater confidence and to build better fit for purpose.

My question is around (unintelligible) smaller enterprises whether they’re 

startups or small enterprises, and an observation of the Software as a Medical 

Device Working Group which seem to cater largely to, you know, the Apples 

and Samsung’s and the very large health or IT players. I don’t have any great 

answers because I know there’s an efficiency problem of how many different 

constituencies you can work with. And I don’t know if it’s venture capital or 

just strictly small business.

But do you have any thoughts about the smaller enterprises are included in the 

discussion about innovation and driving digital health and it’s not just, you 

know, sort of the known top 10 or 20 players?

Bakul Patel: And I would say in fact when we were looking to explore the Pre-certification 

Program and develop that program we are actually looking for the wide

spectrum.

And we do have not - I mean the big names obviously are on the top. And 

people recognize them. But there are some very small players also a part of 

that process. And we are using that as a representation of what we are looking 

at for software as a medical device in the Pre-certification Program. I think 

that’s what you’re referring to.

(Jeff Tackle): Yes.

Bakul Patel: Yes. I think the answer is in short yes. We want to actually enable very 

upstream, as much upstream as possible, the right investment, the right 

mechanism, the right expectation so that when people are creating products 
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they don’t - there’s not an element of surprise of what is expected of people to 

do. I think that’s kind of what Bill was sort of alluding to is that transparency 

and clarity is going to be really helpful for people. And we aim to sort of do 

that.

And I think we have to do it. And I think I would love for everybody to sort 

of continue to sort of take the learnings that we are sharing and the clarity 

we’re providing and continue to sort of, you know, spread that. I think that’s 

how we will probably in a place where people are educated, people are clear 

of the expectations there.

So absolutely, that would be a resounding yes to your question.

(Jeff Tackle): Awesome. Thank you very much. It’s certainly - it’s the number one issue 

having raised money a bunch of times here for startups in the digital health 

space. It quickly comes down to, you know, how does the FDA feel about 

this technology, where are they headed?

And what’s the likelihood that this will be able to navigate that pathway and 

so the more clarity you bring to that, you know, there’s a lot of people and a 

lot of technologies around the great ideas that want to channel themselves to 

these problems so I think that’s tremendous and thank you for this forum and 

the chance to speak. Thank you.

Bakul Patel: Absolutely. And, you know, oh go ahead Jeff, please.

Jeff Shuren: Well I was going to say, you know, that level of clarity, you know, our 

traditional mechanisms, you know, we put out policies with guidance. We 

have formal meetings like pre-subs. And, you know, particularly in a space 

where things, you know, move so quickly is, you know, whether or not we can 
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ever build-out and have the ability to have models where instead of, you 

know, you’re coming to us, you know, we’re there where you’re doing your 

work available to provide that kind of, as I said advice, not just simply, you 

know, feedback.

And could we do it in a way that’s fair because we - you know, across 

developers and in a way that, you know, we’re not involved in the actual 

product development and served in our - in a role as regulator.

But like I say, more is that advisor early on so people can make the smart 

decisions regarding technology. But that would be a profoundly different 

model than what we have today.

(Jeff Tackle): Yes.

Jeff Shuren: And you’re looking at an FDA that really sits and works where you are as 

opposed to you just simply coming to our offices out in White Oak.

And that’s probably a conversation, you know, worth having because that will 

bring that level of predictability, clarity, engagement, to a whole new level.

(Jeff Tackle): Yes. Tremendous

Coordinator: The next participant...

Bakul Patel: So.

Coordinator: ...in the...

Bakul Patel: Sorry. Go ahead Operator. We’ll take the last question.
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Coordinator: The next participant in the queue is (Anil Avanti). Your line is now open.

(Anil Avanti): Hi. Thanks so much and appreciate taking the extra question. So Bakul, Jeff, 

as a former Fed have been following digital health closely. So I had one 

comment/question.

It seems like in terms of the sort of biggest bang for buck, collaboration 

perspective as well as on the sort of regulatory side, when we are developing 

Apps for healthcare the barriers to use are so low. You know it’s sort of like 

no cost to replicate another instance that the circumscription around the 

difference between safe health IT and the safe use of health IT is sort of very 

fluid that it seems like the - not only is the object of attention the actual App 

or the artifact itself that’s doing the reasoning but the context in which it’s 

used and how easily it could be misused is also really important.

And so the implication for collaboration and regulation is that perhaps the 

platforms through which Apps and digital health products are distributed are 

just as important in terms of collaboration and regulation and actually just 

standard development in addition to the products themselves. And that’s 

probably different from the sort of the medical device paradigm.

And then secondly, you know the - being where the product development is 

actually happening it may be not the best example in the last couple years but 

if you looked at collaboration with the FAA and how their safety paradigms 

work in safe - post-marketing, you know, safety as well product development 

so those are the two questions.

Bakul Patel: Yes. (Anil) I think thank you for that comment. I think you just laid another 

engagement sort of and collaboration aspect is about, you know, with other 
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federal agencies and other parties who are increasingly interconnected with 

the health space, with technology.

And I think you’re absolutely right. We are looking at. We’re not - we have 

for example in cybersecurity we are engaged with healthcare sector with large

and (unintelligible) sort of work that’s been going on.

And I think we continue to do that. I think this is a space where connectivity 

is truly ubiquitous. And we’ll end up learning a lot from other areas that we 

have not traditionally needed to learn in medical devices and all medical 

products in general so great, great point.

We are at the top of the - actually at 12:30 so we’re at the end of the session 

here. I just want to take a minute to thank everybody on this call who had 

provided the great insights and the comments and seeing coming through have 

been incredibly helpful. And I want to take a minute to thank all the panelists 

who have been, you know, providing some really great insights and, you 

know, comments.

Before I close, I just wanted to say that this is again the first listening session. 

We have another one coming up in November, on November 12 at 1 o’clock.

And we’ll probably dive deeper into in the next topics. And we’ll continue 

with this collaboration topic. But we’ll probably add another one as well.

But I think where we’re leading off today is a great starting point for all of us. 

And what I heard today is clarity, understanding new opportunities, 

understanding where the intersection happens between different aspects of the 

patient/providers as well as opportunities for us to start thinking outside of the 

box to see where we can, you know, learn, and what FDA can learn and move 
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away from just the info gathering space to actually executing. I think what 

Megan said makes a lot more sense.

And more to come and I think I’m looking forward to working with all of you 

to make sure that the Center of Excellence can actually truly serve all our 

goals, empowerment that we started off with.

With that, Jeff did you have any last thoughts you want to share on this panel 

today?

Jeff Shuren: Just to add my thank you to everyone and, you know, again this is a 

continuation of the journey and we will have lots of opportunities to be 

working together and moving forward and a lot of exciting developments 

underway. So I appreciate your time and attention.

I’ll take a second for a quick plug on the last question for FAA. We’re very 

interested in that model, have been for years. And we’re in the early stages to 

see if we can design something similar for not just the digital health space but 

I think health technology (at large). If you’re interested, check out MDIC’s 

Case for Quality and look under MDIAS, Medical Device Information 

Analysis System, is one of the early pieces for that.

So again, appreciate everyone’s participation today.

Bakul Patel: Thank you Jeff. And thank you Irene for coordinating this session today. 

And I’ll turn it back to you.

Irene Aihie: Thank you Bakul. This is Irene Aihie. And we appreciate your participation 

and thoughtful questions. Today’s presentation and transcript will be made 
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available on the CDRH Learn web page at www.fda.gov/training/cdrhlearn by 

Tuesday, October 27.

If you have additional questions about today’s presentation, please use the 

contact information as provided at the end of the slide presentation.

As always we appreciate your feedback. Following the conclusion of today’s 

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Again, thank you for participating and this concludes today’s session.

END