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0	4320	Hi, everybody. I am Muhammad Ali from Borenger Ingelheim. I lead the digital development
4320	9780	group over there under ClinOps. And I'm here now today to have a fireside chat with Dr.
9780	14220	Amy Abernathy, the Deputy Chief Commissioner for the FDA and the CIO. So looking forward
14220	19160	to discussion with her. I'm sure she has wonderful insights, and we would love to get her perspective
19160	26020	on many things here regarding biosecurity, medical devices, and the overall digital health
26020	27760	space. Dr. Abernathy?
28480	32980	Hi, it's great to meet you, and it's great to be here with you and talk about a pretty
32980	35040	important topic from my perspective.
36560	41820	Fantastic, fantastic. So now with the midst of this pandemic kind of ravaging within the
41820	48260	United States and pretty much many parts of the world, there has been a huge bits of pressure
48260	53300	on enhancing the digital tools and landscape of the ability of types of data that we're
53300	58380	collecting on patients and population in real world. And with increased investments
58380	63200	in digital health so far this year, so far hitting 9 billion just in the first half,
63200	68680	which has been a record so far to date, where do we see the role of real-world evidence
68680	73800	playing in really understanding what to learn about patients and the FDA's perspective around
73800	76880	using real-world evidence for this reason?
77510	85240	So first of all, as I think about the pandemic, if I imagine where we are right now and where
85240	92320	we're going to need to be in managing this virus and the health of our population, we
92320	101880	need to rapidly answer a huge swath of questions right now, which means that while the best
101880	108460	way to answer critical questions is through thoughtful experimental designs like randomized
108460	114860	control trials, we don't have enough clinical trial capacity or enough time to use clinical
114860	118940	trials for every question sitting in front of us. And so we're going to need to leverage
118940	124000	all the data sources currently available, including data sources that are classically
124000	129080	called real-world data sources. These are electronic health records and claims data,
129080	137660	but also include information from social media feeds or from a fitness watch. So many different
137660	145340	data sources that describe a person's health, their activities, what they've experienced,
145340	149980	potential adverse effects of interventions or treatments. We're going to not only need
149980	156320	to learn how to use this information and put it to use for critical questions in COVID-19,
156320	161340	we're going to need to understand when we can rely on it, when is it adequate and credible,
161340	166540	and when do we need to now really direct our clinical trial resources to answer those
166540	172720	questions where real-world data can't help us. That's very helpful. Now, you mentioned social
172720	177640	media. So what would be some of the steps or examples the FDA has taken to kind of discern
177640	181840	what would be a real data source on social media that will be verified versus that of, let's say,
181840	186960	bot posting, that that may lead to some understanding which is not true or lead to
186960	193060	an incidence for patients which could cause potential harm? So before I go to how we might
193060	197140	deal with social media and bots, maybe what I'll do is back up a couple of steps to think about
197140	204060	what we're learning about where real-world data might be put to task. And that will then help us
204060	209600	start to address the questions that you've brought up around social media. So at FDA,
209600	214080	we have been participating in a number of projects inside the agency and outside the agency
215400	220360	to utilize real-world data to address our critical questions. And as we've been doing that,
220360	225060	we've been learning really where we can rely on it, where do we need to do additional work
225060	231680	in order to allow real-world evidence to be credible, and where can't we rely on it. And
232920	238780	examples are questions such as what's the natural history of COVID-19? What are the patterns of
238780	243020	treatments patients are receiving and how have those patterns changed over time? What are new
243020	250060	problems we're dealing with, such as the emergence of clotting disorders or the challenges of late
250060	257780	effects to the heart? And then how does that inform, for example, what treatments may have
257780	262260	differing impacts, both on the safety side as well as the effectiveness of treatments,
262260	267920	and how can we think about the role of diagnostics and differing performance of diagnostics? So
267920	273440	those are some of the kinds of questions that real-world data is being used for. Now you asked
273440	279380	specifically about social media feeds and how do we think about that? Well, practically speaking,
279380	284780	you can imagine that we need to take a series of developmental steps and do this quickly. So first
284780	289280	learning how to use electronic health record data more confidently, claims data, et cetera,
289280	296640	and then starting to layer in new information. And an example is we have been watching some
296640	303700	pretty interesting work happening with Twitter feeds and how Twitter can help to understand
303700	310160	signals that people are communicating about that may deserve additional deep dive attention. So,
310160	319100	for example, one of the areas that really received a lot of attention was around clotting events. And
319760	324700	doctors were noticing clotting events, patients were describing challenges that sounded like
324700	330540	clotting events, which then led to increased understanding that maybe clotting was a challenge
330540	337040	in the context of COVID-19. And so we can use, for example, social media to help to pick up signals
337040	341540	and then use other data sets to verify those signals. And that's something we're just starting
341540	347960	to think about. I wouldn't call this FDA-specific work, but rather work FDA is paying close attention
347960	355780	to. The third part of your question was around where might this go awry? So, for example,
355780	362720	how do we need to think about the role of bots and how that may create misinformation
363480	369560	that may also be one of the signals? And, you know, first of all, be attentive, right? So,
369560	378240	recognize that information may be misinformation and may or may not be nefarious in how it has
378240	388840	occurred. Secondly, to do the experimentation to understand what does inadequate information,
388840	393660	misinformation, nefarious information look like, and be able to identify that quickly. So,
393660	402200	oftentimes, bots have particular patterns that can be identified. And then also be transparent.
402200	407700	I mean, one of the challenges with all these new types of data sources is that perhaps you're
407700	412820	saying, well, we're interested in learning more about how social media data can help. And
413980	419800	the really quick retort is, oh, but that's not reliable because dot, dot, dot, one of which is
419800	428040	bots. And by being transparent that we are curious about some of these new data sources,
428040	435100	but we're also attentive to the potential risks and downsides allows people to know we're paying
435100	440320	attention to all the different aspects. So, this is something that's high in our mind as we start
440320	446500	to think about these new types of data. That's fantastic, Danelle. You mentioned risks when it
446500	451580	comes to these platforms, et cetera. Now, with the rise of digital health and many of these tech
451580	456920	giants really taking a foray into healthcare. Now, having been within the clinical trial space for
457460	461400	almost two decades now, one of the primary steps to get to clinical trials is really informed
461400	465400	consent. Because without informed consent, you really can't get anywhere. And the informed
465400	468900	consent is always for the intended use of the clinical trial that the patient's participating
468900	474400	for, for the data they want to collect for in that trial. Now, with these tech giants, when you have
474400	479620	wearables and devices, even your smartphone with the 11 to 15 sensors that are embedded
479620	484640	within the actual phone itself, you're continuously capturing data to understand not just overall
484640	488840	demographic information, but you understand behavioral patterns, you understand behavioral
488840	494500	impulse control, geographic location, et cetera. What is the FDA's perspective in terms, or even
494500	499160	Amy's perspective, really in this understanding what is the patient's rights in being able to
499160	503420	access this data to get a better understanding of themselves and how it's being used to really
503420	507820	create new services for them that they may not even want or something they can overall contribute
507820	516160	to in the future? Well, so you're bringing up a really important point and focus that's near and
516160	521600	dear to my heart, which is that as we have all of these new data sources, all of these new
521600	530820	capabilities, we also have new challenges as it relates to privacy, a person's rights, how do we
530820	534840	know that information is being used in the way that we intended? In the context of a clinical
534840	541000	trial, I'm an old clinical trial myself, it was quite explicit upfront. Here's what's going to
541000	547000	happen. Here's how my information is going to be used. And those controls are already put in place
547000	554420	in a very explicit way. Within the context of the real world data space, when it's around health,
554420	561960	we have clear laws as it relates to, for example, HIPAA. However, as you start to talk about the
561960	569720	consumer space, as we start to now think about products, you mentioned the smartphone that has
569720	575320	many different sensors and where information may be used in many different ways that are sort of
575320	581680	outside of the traditional context of health information for HIPAA. We now are in a privacy
581680	586800	space and a data utilization space that's very different than that which we envisioned 20 years
586800	594000	ago, to be honest. And I think we're at a place where the EULA, the agreements you sort of
594000	602940	nonchalantly sign off on as you use different software solutions is probably becoming less
602940	609020	and less adequate for making sure that people are fully informed about how their information
609020	614840	is going to be used. So you asked, you know, what's FDA doing? So FDA doesn't really hold,
614840	620620	or under rare circumstances, do we hold identifiable patient health information.
620620	626600	And really, we work under the context of the law, as you can imagine, and that's really not our focus.
627040	634100	So we work in that way. But we are also, though, and I am very much a part of a social conversation
634660	641440	that's really, you know, asking, what does this look like now and into the future? And I think
641440	648080	that as we see these different uses of information, as we also see the different challenges
648080	655340	of how it can be misused, it's forcing us as a society to ask what is and is not okay. Right now,
655340	661140	it's largely in the hands of tech companies that we're sort of all these stories are playing out,
661140	666300	likely needs to be in the hands of all the different people who really are the core to
666300	672580	not only the conversation, but the data. Exactly, exactly. That's a really good point.
672580	677760	Thank you for that. Now, with staying with the tech space, and in terms of cybersecurity,
677760	682260	now you have with the advent of the smartphone since 2007, many of the different applications
682260	687960	of how we live and interact with life are now onto this little rectangular device that we have
687960	692220	in our hands. And that would also include from a health perspective, insulin pumps,
692220	697620	and even glucose monitors, that we can now see the actual overall results of what's happening
697620	703240	inside our bodies on our phones. Now, with many different news articles in the last year,
703240	708180	really coming out that these devices could be hacked into from a cybersecurity perspective,
708180	714180	what has the FDA done to take safety steps and precautions to ensure that these devices meet the
714180	718660	minimum criteria to ensure patient safety, and this would not happen again in the future,
718660	726200	or at least minimize it to some degree? So as FDA, this is a huge area of concern for us.
726200	734520	And certainly has been a core focus of our devices center, CDRH. And I commend them,
734520	739420	but I also commend the entire community for focusing on this. And that's been done both
739420	744560	through public-private partnerships, as well as specifically through work done at FDA,
744560	751320	where we worry about really the development of more secure devices going forward, but also
751320	757880	the challenge of legacy devices that still exist. For example, the insulin pump that was around
757880	768020	since many years ago that may now have a security challenge because those have not been fully
768020	775360	patched. And as FDA, one of the things that we've done is build partnerships. And an example of
775360	783060	those partnerships is with actually DEFCON and the biohacking community. And when I arrived at FDA
783060	793980	about 18 months ago, I was pleasantly surprised to learn that not only were we excited attendees
793980	799640	of DEFCON, that we also participated in the biohacking community and had been doing so
799640	807180	since 2014, I believe. And that in 2019, we even developed the We Heart Hackers initiative really
807640	813620	as a part of our partnership with the white hacking community. And the interesting thing
813620	821220	to me about this work that I've at least learned about is that there have been a number of
821940	828000	companies participating, I think over 40 different devices that have been attempted
828000	834600	to be hacked into and otherwise patched. And really has actually led to a community-based effort
834600	841180	to start to resolve problems that could otherwise hurt patients if they don't get resolved. And so
841180	847340	to me, this is an example of how the FDA has tried to be forward-leaning into this space. And instead
847340	852820	of just writing guidances and saying thou shall or thou shalt, but actually trying to figure out
852820	859760	how we will fix together this particular space. That's amazing. That's really good to hear.
860200	865940	That really brings us to the end of our discussion today. Maybe some last, I guess,
865940	871160	parting words for you, Amy, if you want to share with the audience today in terms of what you would
871160	875740	tell the hacking community and the attendees of this overall conference and what to do and how
875740	879880	best to contribute data so they can, I guess, better not just devices, but really the overall
879880	885680	experience for those that use those devices. Yeah, you know, I've been thinking a lot about
887240	894120	the realities of real-world data, how important I think it's going to be for COVID-19 and how I
894120	900940	think that this sets a template for how we may also use real-world data and real-world evidence
900940	908140	in the future. And then that quickly ports me over to the questions around cybersecurity and
908140	913580	hacking. And why do these two come together? Because if our data sets and our real-world
913580	919160	data sets are important for health in the way that helps us understand not only natural history
919160	925820	disease, but also what treatments are working or downstream safety events of treatments or vaccines,
925820	933040	then those data and the safety of the data themselves and our ability to have confidence
933040	937400	that they haven't been tampered with, that the devices that are generating those data haven't
937400	944140	been tampered with, right, is also a critical task. And so to the white hat hacking community,
944140	950800	I ask us to think about how do we continue to keep our real-world data sources safe because
950800	955720	those data sources are going to be important for actually our overall public health and safety in
955720	959800	the future. And I think that that's going to be an important area of inquiry and questioning
959800	965320	that really hasn't gotten enough attention yet. Thank you for that. That's really helpful. And
965320	968600	it's nice to know that this partnership is going to continue and only probably blossom in the
968600	974140	future to get even more insights that you can possibly get to, I guess, from now on. With that,
974140	981180	that brings us to the end of this fireside chat session. So thank you so much for attending and
981180	983680	have a great conference, everyone. Thank you.