February 25, 2025 • 36 mins
Kevin Malone, Member, Epstein Becker Green, speaks with Jenna Carl, Chief Medical Officer, Big Health, about developments in the use of digital therapeutics for mental health services. They discuss what digital therapeutics are, how they are used in patient care, ensuring safety and effectiveness, regulatory considerations, and the future of the field. From AHLA’s Behavioral Health Practice Group.
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Speaker 1 (00:00):
Speaker 2 (00:04):
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Speaker 3 (00:27):
Hello and welcome , uh, to another a l , a podcast.
Uh, my name is Kevin Malone.
I'm, I'm excited to host thepodcast today on digital
therapeutics and mental health.
Um, I'm a partner at EpsteinBecker Green, and I'm a proud
participant in the BehavioralHealth practice group at A HLA.
Uh, we at the Practice Grouphave been doing a lot to
produce content related to ,uh, all of the many
(00:50):
developments in mental health ,uh, treatment , uh, uh, patient
needs, coverage and paymentpolicy , uh, all of the, the
emerging trends in health lawfor behavioral health. And
today we're, we have a reallygreat topic and I'm, I'm
particularly , uh, excited to ,uh, have , uh, Jenna Carl , uh,
with me today. Uh, Jen , uh,Dr. Carl is the Chief Medical
(01:13):
Officer at Big Health, andshe's a practicing clinical
psychologist who specializes inresearch and treatment of
anxiety, depression, insomnia,and other mental health
conditions. Um, and she leadsthe , uh, company's strategy
on, in an interesting industryleading body of , uh, new
digital therapeutic trtreatments, including sleepio,
(01:35):
daylight and Spark rx. Andtoday we're gonna talk about
what they are doing at BigHealth and what's happening in
digital therapeutics ingeneral. Uh, if you're not
familiar with what we're eventalking about today, of course
Jenna will , uh, uh, reallyilluminate this much more than
I can. But in short, digitaltherapeutics are software-based
(01:56):
interventions that prevent,manage, or treat medical
conditions. And we're reallygonna be focusing today on
developments in the use ofdigital therapeutics for mental
health services. You know, assomeone who represents payers,
providers, trade associations,regulators on , uh,
developments in mental health,and someone who's worked in
mental health policy for a longtime. I think some of these
(02:17):
developments are incrediblyexciting. It's potentially
gonna transform the way inwhich we , uh, receive mental
health care and interact evenwith , um, you know,
traditional mental health. Soit's gonna be a great
conversation. Jenna, thank youso much for being with me
today. I just , uh, thank youfor sharing your time with us.
Speaker 4 (02:39):
Thank you so much for having me, Kevin. Great to
be here .
Speaker 3 (02:42):
So, to start off with, you know, I, I gave
probably like a , you know ,uh, digital Therapeutics for
Dummies explanation about whatit is . But if you could just
take a few minutes and explainas a real professional in the
field what digital therapeuticsare.
Speaker 4 (02:56):
Yeah, well, you did a great job, actually. So the
technical definition is that itis software that is delivering
the intervention. So it is atrue treatment. It is that is
either preventing treating orcuring a disease or medical
condition, and it is thesoftware that is functioning as
that treatment. So that's kindof the core of the definition.
(03:20):
Now, what that means inpractice is that it is
regulated on under FDA , underFDA's , uh, jurisdiction, and
there are a number ofrequirements for a , uh,
digital therapeutic for foursoftware as a medical device
that have to be met in orderfor it to kind of achieve the
(03:42):
standard that is re that it'srequired. So there are
essentially requirements on thequality of the software , uh,
development process andcontrols that make sure that it
changes the software are , um,safe and have been tested, et
cetera. There are requirementsaround cybersecurity and things
(04:04):
to make sure that those risksare, are minimized. And then,
of course, as you, as you know,everyone is , I think, more
familiar with, there arerequirements around
demonstrating safety andefficacy through clinical
research. And so all of thoseare things that are also
required and part of being adigital therapeutic. So I'll
stop there and see if that,that this was quite technical,
(04:25):
so happy to like elaborate.
Speaker 3 (04:26):
No, and , and I mean, it , it , it , I think
that's perfect. I mean, theaudience , uh, through the HLA
is a lot of healthcareregulatory nerds. So it's , uh,
you're in safe. Uh, we're insafe territory here and
getting, getting technical. And, uh, I'll ask some questions
actually a little bit laterabout the way , uh, the sort of
FDA is approaching clinicalstudies on effectiveness and
(04:46):
safety. But I think maybe wecan just talk for a few minutes
about some practicals on the,on the products that you guys
run out of big health and sortof what the , um, what the
actual conditions are. And sortof maybe a little bit as a
clinician, if you could talkthrough like some of the , um,
(05:06):
uh, the way the clinicalintervention works for a
patient , um, and, and sort ofhow your different products ,
um, actually deliver thisclinical care.
Speaker 4 (05:16):
Yeah, absolutely. So at Big Health, we have digital
therapeutics for insomnia,anxiety, and depression. And
for our products, they arebased on a type of behavioral
treatment model, which iscalled cognitive behavioral
therapy, or often referred toas CBT. And that is, that's
(05:40):
essentially a , a type oftreatment that is based on
helping people make changes in, uh, negative patterns of
thinking and behavior that arelike fundamentally the cause
of, or maintaining the clinicalcondition, like the insomnia,
for example. And that can, thisis something you're familiar
with, I think it actually makesa lot of , it makes a lot of
(06:01):
sense. Um, but if you, if youhaven't experienced one of
those conditions or seen it in,you know, a friend or relative,
you may, it may seem, it, it,it may be kind of farfetched.
'cause often people think, oh,you know, you need a medication
to treat those things. Butactually , uh, mental health
conditions, a lot of chronicphy physical disease conditions
are largely caused andmaintained by behavioral
(06:24):
patterns or lifestyle patternsor , um, you know, including
men mental , um, activities .
So ultimately the, you know,one of the leading
evidence-based treatment modelsfor many , for many conditions,
but particularly mental health,is co cognitive behavioral ,
(06:45):
um, based , may based methods.
And so what we've done at BigHealth is essentially taken ,
uh, these types of treatments,which are typically delivered
by a very deeply trained , uh,therapist specialist. Um ,
could be a psych , often apsychologist, could also be a
psychiatrist. Um, there's othertypes of mental health
professionals, but typicallythese are interventions that
(07:07):
are, they're structured,they're skill-based, and
they're delivered over a periodof weeks , um, meet, you know,
typically meeting with apatient and then following up
with them , um, to providehomework to practice the
skills. It turns out that thesetypes of tech types of
treatments are really amenableto digitizing. You can, you
know, in fact, like a lot ofthe aspects of the learning the
(07:28):
skills and applying them inyour daily life and this , you
know, need the structureneeding to capture data is like
great in digital format. And sothat's really what we've done
is create these fully automatedsoftware based interventions
that are walking people throughthese cognitive and behavioral
skills that they need to, thatthey can adopt, that are gonna
(07:48):
address the roots of theirproblems with, you know,
insomnia, anxiety , depression,the , so the programs are fully
automated, they're patientfacing , um, people tend to use
them for , uh, around two tothree months, and it's really
about learning new skills andthen practicing them in your
real world environment. Uh, andwe have a , so our program for
(08:11):
insomnia is called sleepio rx.
Um, we have a program programfor daylight , uh, sorry, for,
for generalized anxietydisorders called Daylight rx.
And these are programs thathave been around , um, for a
long time and while, andevidenced, and we recently took
them through FDA clearance aswell to really ensure , um,
(08:31):
that they have that level of ,um, you know, authorization
and, and, and , uh, overview.
And it , it allows them to beoffered really more through
traditional healthcarepathways. So , um, yeah, let me
stop there, but let , let meknow if I'm, what I, what I
missed, what people might wannaknow more about.
Speaker 3 (08:49):
Yeah, no, I think that , um, you know, many
people are familiar withcognitive behavior therapy in ,
um, in the abstract, but I, Iwas actually a, a , a
psychology undergrad , uh,major. And I remember like
learning about CBT and sort ofthe theory of learning , uh,
(09:09):
and the interaction of the, youknow , the learning brain and,
and behavioral patterns waslike one of the greatest, like
transformations in my own like, uh, adulthood even. And sort
of like understanding, youknow, the, the sort of paradox
of our freedom as, as, asagents in the world that we are
(09:31):
learning , uh, habitual , uh,conditioned organisms, but our
awareness of those patternsactually , uh, gives us more
control over them. There's thislike, incredible interaction
between , uh, sort of awarenessof our own cognitive
limitations and our own conlike, you know, our, our own ,
(09:52):
um, dependencies , uh, to, toactually add more contingency ,
uh, in our life. And I thinkthe, I i I , one of the reasons
I wanted to do this podcast wasthat I, I like having thought
about CBT and understand andhaving experienced it sort of
certainly interacted with otherprovider types that are trying
(10:12):
to deliver it as a packageintervention of limited
duration with very specificmeasurable outcomes of what
success looks like with regardsto , uh, symptom change and
behavior change. Um, it seemedthat software was like,
especially , it might even bemore effective than traditional
therapy because as , as we allare talking about in the
(10:33):
context of social media and theevolution of , uh, you know,
technology and the internet inour lives, we are, we are aware
of software doing this whetherwe like it or not. And , uh,
that in some ways what you guysare doing is sort of leveraging
the, like, incredible power ofour interaction with technology
(10:54):
for our , uh, for theimprovement of our mental
health in a way that I justthink is like really
extraordinary. So, I mean , uh,if you don't mind, like sort of
elaborating a little bit aboutthe way people interact with
the software in a way thathelps them, like recognize
their own thought patterns andpractice new cognitive skills
(11:15):
in like, changing the way theyinteract with their own
thoughts.
Speaker 4 (11:19):
Yeah, absolutely.
Yeah, no, it , I mean,honestly, I could , uh, nerd
out a lot. Um, it'squite fascinating I think when
you, when you realize thatchanging your behavior actually
changes your biology, right?
People , it's, it we, forwhatever reason in modern day,
I think we had , uh, we weremore of this mindset that like,
oh, the only way to changebiology is to change biology,
(11:41):
but actually behaviorenvironment, it all changes
biology. And so it just meansthat people can really be the
agents of their, their ownchange and their own health in
a far more deep way than Ithink we may have previously
thought. And that is reallywhat CBT does. And I think to
(12:01):
your point , um, it can bereally helpful in a more
structured way and in a waythat reaches people at moments
of their life where they needto be making changes. And so it
, it ultimately, cognitivebehavioral therapy is very
structured, and it is becauseyou need to, and so I maybe
(12:24):
just take , take for example,our program sleepio, which is
for insomnia , um, to treatinsomnia, you really wanna
understand what the root causesof insomnia are for that
person. And then you wannaprovide specific interventions
to change the areas that arecausing the problem. And so the
(12:44):
way that you do that inpractice is through collecting
a lot of information around thesleep patterns, around the
thinking patterns people havearound their sleep. And once
you do that, you can puttogether what we call in
clinically a case formulationof, you know, what, what's,
what the pattern is that'scausing the problems and like
(13:06):
what the, the treatment is thatwill resolve it. And so you can
imagine just from like thetracking and assessment
standpoint, those are kind offormulaic questions that can be
done, collected very well , um,you know, through a digital
device. And then there's a lotof sort of calculation of
(13:27):
different aspects of thetreatment. So, you know, one
thing you wanna focus on iscorrecting a patient's sleep
window such that they'regetting into bed at the best
time for them and they'regetting outta bed the right
time, and we're trying to dothings to compress their sleep
so they get more consolidatedsleep, which is one of the big
problems insomnia, is peopletend to, you know, sort of get
(13:49):
fragmented sleep and have ahard time falling asleep or
waking up, et cetera . And soit's really, we're using that
the data, we're collecting thedevice to then recommend a
sleep window and then to coachpeople within the device around
how to use the sleep window.
Uh, and then, you know, if theywake up in the night or have
trouble falling asleep, wewanna have real time techniques
(14:11):
that they can use in thosemoments to facilitate , uh,
falling back asleep or doingthings that would reduce the
anxiety or tension that are,you know, causing the insomnia.
Uh, so it's all to say thoseare, none of those things are
things that would occur, likewhile you're in a therapist's
office,. And , uh,there are things that require
kind of this iterative datafeedback loop as well. And they
(14:33):
are, they also require thepatient to take actions , um,
and reduce specific things andmoments in time. And so it
just, it just lends itself verywell to a digital format. Um,
but one thing I wanna add aboutthat is that doesn't, that does
not mean that there aren'taspects of a, a therapeutic
process that are not solvedwell by the digital device per
(14:55):
se. Like you can imagine what'snot present in what I just
described is like thattherapist giving you that warm
support and telling you like,this is so hard. I know this is
so hard, like, here , let me,let me talk to you about how
you can get through this ormake this like, really like
practical. Um, but I think thatthose, so it's not to say that
you, you, you can't combinegreat human delivered therapy
(15:18):
with these types of treatments,but the flip side is that no
one really wants to talk aboutinsomnia, right? If you imagine
like, you don't, people don't,people don't say, God, I can't
wait to talk to my therapistabout Sonia . So
there's this, like, there'sreally like the part that the
device does really well, andthen there's the part that like
an actual human provider can doreally well. And I think that's
(15:40):
where there's some real magicaround getting people great
outcomes and also , um, youknow, getting them emotional
support or other things neededfrom a therapist at the same
time.
Speaker 3 (15:50):
Yeah, that's great .
I mean, that was really gonnabe one of my next questions was
like, obviously you're apracticing , uh, clinical
psychologist , um, uh, not justa , uh, an executive and , and
develop and , and medicalofficer. Um, how , how do you,
like, as in your own practice,like if you had, if you , I
don't know if you stillmaintain a private practice,
(16:12):
but if you, if you had apractice, how would you deploy
this, these tools , uh, insupport of your patients?
Speaker 4 (16:19):
Yeah, I am still practicing. It's a small
practice given my other timecommitments. The way that I
deploy them and recommendothers deploy them are in a
couple ways. So I would say oneis for someone like me that's
like, I'm a CBT expertclinician, I use them as
reinforcers to what I'm doingwith patients in practice. And
(16:41):
so, like, I might be workingwith them on aspects of their
sleep and insomnia or aspectsof anxiety, and I could still
refer them to , uh, sleepio ordaylight to help them to
compliment what we're doing inperson to practice it outta
session, to collect the dataoutta session, give me, I , I
see the data feedback back onhow they're doing and what's
working, what's not working, etcetera. So that's one option.
(17:04):
Um, but another, if youimagine, you know, a primary
care physician who , uh, isseeing a lot of patients is
not, doesn't , is probably notreally trained in CBT, nor has
the time to provide CBT forpatients or, you know, or other
evidence-based , um, uh,behavioral approaches. And so
(17:24):
that type of provider canreally use a pro , uh, like a
program like programs like oursto compliment what , what
they're doing and, and makesure that they have, they can
actually get their patientaccess to the first line
evidence-based treatmentapproach for insomnia versus
the only option they have intheir toolkit being medication.
(17:44):
And so that's a , it is like a,it's very significant that I
would say , uh, the, thenumber, if you think about
mental health, the conditionsof mental health show up across
all different types of caresettings. And many, many of
those practitioners are not ,um, the ones that can provide
(18:07):
some of these techniques, someof these approaches. And so
there's these big access gapsand it's, you know, typically
patients have to wait months ,uh, on wait list to get access
to CBT. It's also quiteexpensive to do it in person .
And so there's a, the , theultimately treatments like this
can be a way for people to getmuch faster access and have a
(18:29):
provider overseeing the care,but the provider doesn't have
to be an expert c you know, CBTpractitioner themselves.
Speaker 3 (18:35):
Yeah. They just need to have the empathy to
understand the, you know, someof the difficulties that go
through , uh, that, that, thatour attendant in going through
such , uh, therapy. Um, yeah,no, I , the way that I, I've
always thought about it was,you know, in, in , um, you
(18:56):
know, in, in like 12 stepprograms, like in AA or , or
na, I sort of have alwaysconsidered those to be
basically like self deliveredCBT , uh, programs. And the
sponsor is really someone whois just a , um, an emotional
support person to the, to theparticipant because of how
(19:17):
uncomfortable it can be attimes to restructure your
thought patterns. Like it'snot, it's not the easiest walk
in the park. This isn't justsort of affirmation, it is ,
uh, cognitive change skillschange, which like working out
at the gym can can bepainful. Yeah.
Speaker 4 (19:34):
Yeah, absolutely.
Speaker 3 (19:35):
Yeah. Well, that's, that's really fascinating. So ,
um, you , you know, you sort ofalluded to this, but I think
from a regulatory perspective,it's helpful to maybe step back
for our , our legal andregulatory audience, you know,
and you know, the, the, thereis an FDA approval pathway
where digital therapeutics areregulated by as a medical
(19:57):
device. And then CMS hasrecently issued a physician fee
schedule , uh, codes , uh, Gcodes under the
program for coverage , uh,incident two , uh, professional
services. Um, and, and on the ,uh, on the FDA side, you know,
you, you mentioned that therereally is a requirement to
(20:19):
demonstrate effectiveness andsafety as well as some other
very specific software specificcriteria that they've developed
, um, to support this industry.
I was wondering if you could,obviously, you mentioned some
of these tools from Big Healthhave been out there for a while
, but could you talk a littlebit about the studies that you
guys ran and sort of like howthe study process goes on
(20:43):
safety and effectiveness?
Speaker 4 (20:45):
Yeah , absolutely.
So, I mean, big Health wasfounded by , uh, one clinical
psychologist and researcher. Soone of the, the co-founders ,
um, is a sleep clinician andresearcher. And so, and, and
I'm a clinician and researchermyself as well. And so from the
very beginning, we were alwaysvery focused on the importance
(21:09):
of demonstrating safety andefficacy in good clinical
research. And interestingly,when we started out , um, it
was early in like , I think2010 , uh, there FDA was not
regulating in this space. Itdidn't exist. This was, that
was pre-digital therapeuticterminology. So , um, this is,
you know, it's been a , it'sbeen an evolving space , um,
(21:30):
which is super interesting toreflect on. And so we, we
actually spent a long time ,um, you know, providing our
therapeutics in different,different settings from
populations publishing lotresearch. We basically early on
created a scientific set ofprinciples around making our
(21:50):
products as, as , um, sort offreely available to researchers
that would do high qualityresearch on them . And as a
result , um, just sleep . Imean, sleepio and Daylight have
both been in many, many studiesas Spark as well, the
Depression program. Um, butyeah, I think, I think SLEEPIO
is in like over 40, has likeover 45 published clinical
(22:11):
trials on it at this point. Soat the point that the FDA
started regulating in thespace, and we started thinking
about, you know, wanting to getFDA clearance and going down
that pathway, we already had areally large evidence base.
Then it still was aninteresting discussion to sort
of align with FDA'sexpectations around, well, what
(22:33):
is, what are their criteria forthese new class of treatments?
Which, as you mentioned, they,they consider medical devices,
so software's, medical devices,and, and it , and it gets kind
of nuanced at that pointbecause FDA medical devices
have, you know, kind ofdifferent standards for whether
it's like a de novo applicationor , um, a five 10 K, which,
(22:54):
you know, follows a , apredicate device. Um, but in
either case, there arerequirements for clinical
safety and efficacy, but it'sthe , you know, it could be
originally in de Novo's case,you know, you're sort of
proving the original , um, theoriginal case of efficacy
versus five 10 K , it's moreabout showing substantial
(23:14):
equivalence to the predic to apredicate device. Uh, and so
for big health, there wasalready an existing FDA
classification, which I'm notgonna be able to rattle off the
number for right , Irealize I should , I could, I
could pull it up if, if , but it was , um,
ultimately it was forcomputerized behavior therapy
for psychiatric disorders. Andour , our understanding is FDA
(23:38):
intended that classification assort of an umbrella code that
any digital therapeuticstreating psychiatric disorders
could theoretically fall underand submit applications under.
And so that's what we did. Andso therefore for us, the , the
, this expectation was showingsubstantial equivalence to
devices that had already beencleared in that, in that
category. And to be honest ,um, it, you know , it was , we
(24:02):
thought it was a appropriatelyhigh bar , uh, because the,
there were similar productdevices to what we had that,
you know, had, had greatresults against a rigorous ,
rigorous control condition. Um,so, you know, the in, in
medicine, the standard isconducting a randomized
controlled trial , uh, which wethink is, which we think is ,
(24:23):
uh, appropriate. And so we, youknow, that's what we had to
show and de and use to, to showsafety advocacy for, for FDA
clearance. And, you know,fortunately, like I said, we'd,
we'd been doing our CTS formany, many years, so we
actually had , um, many, manyconsistently replicating
efficacy, but still, there'sFDA requires very, very
(24:46):
specific requirements for otherclinical trials . So we did
actually for both Sleepio anddaylight conduct additional
separate trials that werespecifically , um, under all of
the exact controls needed forFDA . So we did, you know,
there is , there was an extramile we did even for FDA , even
after having that rigorousevidence base .
Speaker 3 (25:05):
That's great. Yeah, no, I , I think in , um, uh, it
, you know, I work with anumber of , uh, specialty
societies and development ofnew clinical , uh, procedures.
And I can say that, you know,in , in many ways, having like
rigorous third party oversightof safety and efficacy of any ,
uh, of any procedure is, isessential for ensuring that
(25:28):
that patients have access tothat , that they know that what
they're, they're buying isgonna work. And that when , uh,
'cause you can, if, you know,if you don't have that, people
won't have any credibility init. You have other regulators
coming in to prohibit things.
It's, it's really essential forthe, the sustaining of
advancement. So I that's,that's really fascinating.
Speaker 4 (25:49):
Yeah, and you can actually , can I just, I was
gonna , one thing, maybe I wasbeing sort of like , um, high
level , but I was realizing, II maybe worth clarifying it,
you know, we actually , um, youknow, we, in our research we
had shown , uh, outcomes thatwere, you know, it's really
(26:10):
relatively on par with standardof care. And as a result, we
had sleepio, for example, hasbeen recommended in clinical
treatment guidelines, firstline ahead of medication in a
number, a number of differentguidelines in the US and the
uk. And that actually happenedprior to FDA clearance. And so
it was very interesting becauseit's, we still with FDA , it's
(26:32):
still a very, it's a veryspecific requirement around
kind of matching to, you know,predicate research and other PO
and other things. So , um, itis, I do, this is all to say
like, I do think that FDA isnot, FDA is a , is a very
important , um, stakeholder inthis. I do think that evidence,
(26:55):
clinical evidence ultimately inmany cases needs to go beyond
just what's required for FDA .
And so I didn't wanna , Ididn't wanna like, you know,
inadvertently suggest that thatall you, you know, all that's
needed is your clinical trialto kind of get through FDA
clearance.
Speaker 3 (27:09):
No, and I , I think that's actually a perfect segue
to kind of the next question.
'cause I know that you've beeninvolved with the , uh, you
know, American psychiatric ,uh, association and oh , no ,
pardon me, the AmericanPsychological Association,
gotta get your APAs correct.
, that's the worst kindof mistake to make. Um, and ,
um, you know , uh, obviously alot of specialty societies in
(27:33):
medicine develop , uh, theirown clinical standards based on
studies on efficacy and refinethem that go into clinical
coverage guidelines and arecompletely independent of
anything that the FDA doesrelated to medical devices. And
I think digital therapeutics, Ithink presents a fascinating ,
um, uh, sort , sort of like a ,a really fascinating challenge
(27:55):
to the traditional regulationof the practice of clinical
interventions in the sense thathistorically, you know, each ,
uh, state governs the practiceof professional services and
the boards regulate the scopeof what is like within the
bounds of clinical practice.
But then national sort of , uh,societies would be responsible
(28:18):
for, or currently are kind ofempowered to set, you know,
the, the standards forreceiving , uh, certification,
you know, for , for boardcertification. And they, they
certainly publish most of theimportant clinical guidelines
that govern the practice of, ofmost , uh, of many, many actual
procedural interventions. Andwhat we're talking about is a
(28:41):
procedural intervention, but itis also , uh, regulated as
medical advice. So like , uh,uh, can you talk a little bit
about how the, like how theprofessional fields like that
is on that legacyinfrastructure of state boards,
national associations, like howit's interacting with this sort
of evolving field of clinicalinterventions?
Speaker 4 (29:02):
Yeah, absolutely.
Well, I can say to start offwith, we have had a really
important partnership with theAmerican Psychological
Association for a number ofyears now because we both
realize the importance of theother party, like big, big
health. We may have productsthat help , uh, with, with
(29:23):
people's mental health needs,but we are not the ones , um,
seeing patients and in aposition to distribute them in
a PA has the psychologists thatneed treatments like ours. And,
you know, we've been partneredon some really infor important
work advocacy work to cut , tomove the field forward. And so
I think you , um, it wasimportant for us for, I should
(29:44):
say, for both groups to makesure that the broad set of
mental health professionalswere included in , um, both ,
uh, requirements aroundauthorizing use for programs in
these areas as well as forbeing able to be reimbursed.
And so we certainly didn't wantto , um, have policies created
(30:05):
that we're going to be limiting, limiting patient access. I
mean, the whole point withwhat, you know , um, I've been
trying to do as a professional,and I think what we've been
trying to big health is toincrease access to
evidence-based mentalhealthcare , which has
historically been incrediblychallenging. And so , um, it's
(30:26):
a , so yeah, so I'd say there'sa lot of work that can be done
with professional associations,invol , you know , um, that ,
uh, represent the differenttypes of mental health
practitioners. And it's, youknow, it's not just mental
health practitioners, obviouspri you know, primary care
physicians , uh, sleep medicine, um, providers have been
reaching out to us for yearswanting to be able to
(30:49):
collaborate and use programslike ours in our practices. But
it's definitely a, it'sdefinitely a, a group exercise
as they say it .
Speaker 3 (30:57):
Yeah. And I , uh, honestly, I think that's the
perfect segue into what I wouldsay is kind of my last
question. Um, I know I've takena lot of your time, but is is
really about, about the futureand sort of about how the
software can potentiallyaddress what you sort of
alluded to, which is, you know, we have a , uh, I work a lot
of mental health paritycompliance , uh, with payers
(31:17):
and sort of policy issues aboutworkforce and supply of, of
Care A and behavioral healthhas , uh, across the continuum
from like anxiety anddepression, serious mental ,
all the way up to seriousmental illness. And , uh, you
know, all across the substanceuse disorder continuum, there's
a shortage. People have chroniclack of access they cannot find
(31:38):
in-network providers. And youmentioned it earlier in the
presentation today, the cost ,uh, and delays are , uh, it's a
pervasive problem. People don'teven , uh, we, I regularly
encounter people who don't eventry to get coverage for mental
healthcare through theirtraditional insurance 'cause
they just presume that it's noteven available. Yeah. And so ,
(31:59):
uh, interested in yourperspective, like where do you
hope this will go, like in, infive or 10 years? Like how, how
will this , uh, this trend, notjust the products you guys
currently have, but the fieldoverall, like, how do you think
that this is gonna play out?
And obviously I won't hold youto it, but I would love to hear
what you would like to seehappen and where do you see it
(32:20):
going?
Speaker 4 (32:21):
Yeah, well thanks for the opportunity to project.
Uh, so I think that it's gonna, there's gonna be a big act ,
um, impact for patients andproviders and for patients. I
think the big impact is thatthey are going to have much
faster access to evidence-basedcognitive and behavioral
(32:42):
therapies. Uh, again, and therecould be some other types, but
those are, those arepredominantly the type that you
see , um, represented indigital therapeutics. So I
think they'll have fasteraccess those, what they'll be
getting will be trulyevidence-based. So it will be,
you know, they'll be, they'llbe getting a high fidelity
treatment that is shown todeliver good outcomes, and it
(33:05):
will, it allows them to havetreatment options that match
their preferences. So it's allto say that not every patient's
gonna want a digitaltherapeutic, but there are a
lot that will , um, there's alot of patient patients that do
not wanna take a medicationincreasingly these days. It's,
it's , uh, the culturalsensibilities are changing. Um,
so it , it's gonna really allowfor patients to ha have
(33:28):
different options and to havefaster access to good care ,
uh, at , at a reasonable pricepoint as well. Um, I would say
separate for providers, I thinkit's really gonna change how
they practice. And I've heard alot of enthusiasm from
different provider types abouthow this allows them to in grow
(33:51):
and improve their practice. Andso ultimately you can have
providers doing more, spendingtheir time doing what is
important for them to do. Um ,so , uh, instead of a provider
having, you know, have , havingto do everything and maybe
stretch beyond their comfortzone, if they're not, you know,
they don't feel expert in CBTfor every single condition,
(34:11):
which they, they shouldn't'cause most people are not. Um,
it allows them to do the partthat they really excel in and
then to support their patientswith additional options. And it
also, it can improve how theyuse clinician resources in a
practice. And so if you thinkabout, like, I think there's
gonna be structural changes tothinking about, well , um,
(34:34):
there we could have cliniciansand coaches that specifically
are overseeing kind of firstline access to digital
therapeutics. And then, youknow, for some patients that
don't want those or that one ,you know, need higher intensity
care, those can be referred toour specialists. And so you can
reserve like the right time forthose like small number of
(34:55):
specialists. So I think you'll,like, honestly, I think it'll,
we'll need just as many if notmore mental health
professionals , uh, and youknow, and , and , and
providers. But what they'redoing can be more aligned , um,
with what patients want, withwhat their expertise is, and
then more aligned with like theright cost base. So I think
(35:16):
they'll just be great. There'llbe growth and efficiencies that
are provided to provider, to,you know, provider groups and
health systems based on havingthis new , uh, type of care
option.
Speaker 3 (35:29):
That's really exciting. Yeah, I mean , I hope
in the, in coming years, likelearning how to use these will
be integrated into, you know ,know clinical education across
the, you know, the spectrum ofproviders , uh, from primary
care to behavioral healthpractitioners. 'cause I think,
you know, like many of the newtools, like even using a AI in
(35:50):
the workplace, like I thinklearning to use these tools is
gonna hopefully become like acore professional competency ,
uh, of any , uh, clinician. So, uh, that's super exciting.
And Jenna, well, I just gottathank you again so much for
taking the time to jump on thepodcast and , um, uh, wanna
plug again the HLA behavioralpractice group , uh, the , they
(36:11):
supported me and , uh, uh,getting this podcast together.
And , uh, thank you all forlistening.
Speaker 5 (36:17):
Thanks so much, Kevin.
Speaker 2 (36:24):
Thank you for listening. If you enjoyed this
episode, be sure to subscribeto ALA's speaking of health law
wherever you get your podcasts.
To learn more about a HLA andthe educational resources
available to the health lawcommunity, visit American
health law.org.
Speaker 2 (00:04):
ALA's, popular Health Law Daily email
newsletter is now a dailypodcast exclusively for a HLA
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Speaker 3 (00:27):
Hello and welcome , uh, to another a l , a podcast.
Uh, my name is Kevin Malone.
I'm, I'm excited to host thepodcast today on digital
therapeutics and mental health.
Um, I'm a partner at EpsteinBecker Green, and I'm a proud
participant in the BehavioralHealth practice group at A HLA.
Uh, we at the Practice Grouphave been doing a lot to
produce content related to ,uh, all of the many
(00:50):
developments in mental health ,uh, treatment , uh, uh, patient
needs, coverage and paymentpolicy , uh, all of the, the
emerging trends in health lawfor behavioral health. And
today we're, we have a reallygreat topic and I'm, I'm
particularly , uh, excited to ,uh, have , uh, Jenna Carl , uh,
with me today. Uh, Jen , uh,Dr. Carl is the Chief Medical
(01:13):
Officer at Big Health, andshe's a practicing clinical
psychologist who specializes inresearch and treatment of
anxiety, depression, insomnia,and other mental health
conditions. Um, and she leadsthe , uh, company's strategy
on, in an interesting industryleading body of , uh, new
digital therapeutic trtreatments, including sleepio,
(01:35):
daylight and Spark rx. Andtoday we're gonna talk about
what they are doing at BigHealth and what's happening in
digital therapeutics ingeneral. Uh, if you're not
familiar with what we're eventalking about today, of course
Jenna will , uh, uh, reallyilluminate this much more than
I can. But in short, digitaltherapeutics are software-based
(01:56):
interventions that prevent,manage, or treat medical
conditions. And we're reallygonna be focusing today on
developments in the use ofdigital therapeutics for mental
health services. You know, assomeone who represents payers,
providers, trade associations,regulators on , uh,
developments in mental health,and someone who's worked in
mental health policy for a longtime. I think some of these
(02:17):
developments are incrediblyexciting. It's potentially
gonna transform the way inwhich we , uh, receive mental
health care and interact evenwith , um, you know,
traditional mental health. Soit's gonna be a great
conversation. Jenna, thank youso much for being with me
today. I just , uh, thank youfor sharing your time with us.
Speaker 4 (02:39):
Thank you so much for having me, Kevin. Great to
be here .
Speaker 3 (02:42):
So, to start off with, you know, I, I gave
probably like a , you know ,uh, digital Therapeutics for
Dummies explanation about whatit is . But if you could just
take a few minutes and explainas a real professional in the
field what digital therapeuticsare.
Speaker 4 (02:56):
Yeah, well, you did a great job, actually. So the
technical definition is that itis software that is delivering
the intervention. So it is atrue treatment. It is that is
either preventing treating orcuring a disease or medical
condition, and it is thesoftware that is functioning as
that treatment. So that's kindof the core of the definition.
(03:20):
Now, what that means inpractice is that it is
regulated on under FDA , underFDA's , uh, jurisdiction, and
there are a number ofrequirements for a , uh,
digital therapeutic for foursoftware as a medical device
that have to be met in orderfor it to kind of achieve the
(03:42):
standard that is re that it'srequired. So there are
essentially requirements on thequality of the software , uh,
development process andcontrols that make sure that it
changes the software are , um,safe and have been tested, et
cetera. There are requirementsaround cybersecurity and things
(04:04):
to make sure that those risksare, are minimized. And then,
of course, as you, as you know,everyone is , I think, more
familiar with, there arerequirements around
demonstrating safety andefficacy through clinical
research. And so all of thoseare things that are also
required and part of being adigital therapeutic. So I'll
stop there and see if that,that this was quite technical,
(04:25):
so happy to like elaborate.
Speaker 3 (04:26):
No, and , and I mean, it , it , it , I think
that's perfect. I mean, theaudience , uh, through the HLA
is a lot of healthcareregulatory nerds. So it's , uh,
you're in safe. Uh, we're insafe territory here and
getting, getting technical. And, uh, I'll ask some questions
actually a little bit laterabout the way , uh, the sort of
FDA is approaching clinicalstudies on effectiveness and
(04:46):
safety. But I think maybe wecan just talk for a few minutes
about some practicals on the,on the products that you guys
run out of big health and sortof what the , um, what the
actual conditions are. And sortof maybe a little bit as a
clinician, if you could talkthrough like some of the , um,
(05:06):
uh, the way the clinicalintervention works for a
patient , um, and, and sort ofhow your different products ,
um, actually deliver thisclinical care.
Speaker 4 (05:16):
Yeah, absolutely. So at Big Health, we have digital
therapeutics for insomnia,anxiety, and depression. And
for our products, they arebased on a type of behavioral
treatment model, which iscalled cognitive behavioral
therapy, or often referred toas CBT. And that is, that's
(05:40):
essentially a , a type oftreatment that is based on
helping people make changes in, uh, negative patterns of
thinking and behavior that arelike fundamentally the cause
of, or maintaining the clinicalcondition, like the insomnia,
for example. And that can, thisis something you're familiar
with, I think it actually makesa lot of , it makes a lot of
(06:01):
sense. Um, but if you, if youhaven't experienced one of
those conditions or seen it in,you know, a friend or relative,
you may, it may seem, it, it,it may be kind of farfetched.
'cause often people think, oh,you know, you need a medication
to treat those things. Butactually , uh, mental health
conditions, a lot of chronicphy physical disease conditions
are largely caused andmaintained by behavioral
(06:24):
patterns or lifestyle patternsor , um, you know, including
men mental , um, activities .
So ultimately the, you know,one of the leading
evidence-based treatment modelsfor many , for many conditions,
but particularly mental health,is co cognitive behavioral ,
(06:45):
um, based , may based methods.
And so what we've done at BigHealth is essentially taken ,
uh, these types of treatments,which are typically delivered
by a very deeply trained , uh,therapist specialist. Um ,
could be a psych , often apsychologist, could also be a
psychiatrist. Um, there's othertypes of mental health
professionals, but typicallythese are interventions that
(07:07):
are, they're structured,they're skill-based, and
they're delivered over a periodof weeks , um, meet, you know,
typically meeting with apatient and then following up
with them , um, to providehomework to practice the
skills. It turns out that thesetypes of tech types of
treatments are really amenableto digitizing. You can, you
know, in fact, like a lot ofthe aspects of the learning the
(07:28):
skills and applying them inyour daily life and this , you
know, need the structureneeding to capture data is like
great in digital format. And sothat's really what we've done
is create these fully automatedsoftware based interventions
that are walking people throughthese cognitive and behavioral
skills that they need to, thatthey can adopt, that are gonna
(07:48):
address the roots of theirproblems with, you know,
insomnia, anxiety , depression,the , so the programs are fully
automated, they're patientfacing , um, people tend to use
them for , uh, around two tothree months, and it's really
about learning new skills andthen practicing them in your
real world environment. Uh, andwe have a , so our program for
(08:11):
insomnia is called sleepio rx.
Um, we have a program programfor daylight , uh, sorry, for,
for generalized anxietydisorders called Daylight rx.
And these are programs thathave been around , um, for a
long time and while, andevidenced, and we recently took
them through FDA clearance aswell to really ensure , um,
(08:31):
that they have that level of ,um, you know, authorization
and, and, and , uh, overview.
And it , it allows them to beoffered really more through
traditional healthcarepathways. So , um, yeah, let me
stop there, but let , let meknow if I'm, what I, what I
missed, what people might wannaknow more about.
Speaker 3 (08:49):
Yeah, no, I think that , um, you know, many
people are familiar withcognitive behavior therapy in ,
um, in the abstract, but I, Iwas actually a, a , a
psychology undergrad , uh,major. And I remember like
learning about CBT and sort ofthe theory of learning , uh,
(09:09):
and the interaction of the, youknow , the learning brain and,
and behavioral patterns waslike one of the greatest, like
transformations in my own like, uh, adulthood even. And sort
of like understanding, youknow, the, the sort of paradox
of our freedom as, as, asagents in the world that we are
(09:31):
learning , uh, habitual , uh,conditioned organisms, but our
awareness of those patternsactually , uh, gives us more
control over them. There's thislike, incredible interaction
between , uh, sort of awarenessof our own cognitive
limitations and our own conlike, you know, our, our own ,
(09:52):
um, dependencies , uh, to, toactually add more contingency ,
uh, in our life. And I thinkthe, I i I , one of the reasons
I wanted to do this podcast wasthat I, I like having thought
about CBT and understand andhaving experienced it sort of
certainly interacted with otherprovider types that are trying
(10:12):
to deliver it as a packageintervention of limited
duration with very specificmeasurable outcomes of what
success looks like with regardsto , uh, symptom change and
behavior change. Um, it seemedthat software was like,
especially , it might even bemore effective than traditional
therapy because as , as we allare talking about in the
(10:33):
context of social media and theevolution of , uh, you know,
technology and the internet inour lives, we are, we are aware
of software doing this whetherwe like it or not. And , uh,
that in some ways what you guysare doing is sort of leveraging
the, like, incredible power ofour interaction with technology
(10:54):
for our , uh, for theimprovement of our mental
health in a way that I justthink is like really
extraordinary. So, I mean , uh,if you don't mind, like sort of
elaborating a little bit aboutthe way people interact with
the software in a way thathelps them, like recognize
their own thought patterns andpractice new cognitive skills
(11:15):
in like, changing the way theyinteract with their own
thoughts.
Speaker 4 (11:19):
Yeah, absolutely.
Yeah, no, it , I mean,honestly, I could , uh, nerd
out
you, when you realize thatchanging your behavior actually
changes your biology, right?
People , it's, it we, forwhatever reason in modern day,
I think we had , uh, we weremore of this mindset that like,
oh, the only way to changebiology is to change biology,
(11:41):
but actually behaviorenvironment, it all changes
biology. And so it just meansthat people can really be the
agents of their, their ownchange and their own health in
a far more deep way than Ithink we may have previously
thought. And that is reallywhat CBT does. And I think to
(12:01):
your point , um, it can bereally helpful in a more
structured way and in a waythat reaches people at moments
of their life where they needto be making changes. And so it
, it ultimately, cognitivebehavioral therapy is very
structured, and it is becauseyou need to, and so I maybe
(12:24):
just take , take for example,our program sleepio, which is
for insomnia , um, to treatinsomnia, you really wanna
understand what the root causesof insomnia are for that
person. And then you wannaprovide specific interventions
to change the areas that arecausing the problem. And so the
(12:44):
way that you do that inpractice is through collecting
a lot of information around thesleep patterns, around the
thinking patterns people havearound their sleep. And once
you do that, you can puttogether what we call in
clinically a case formulationof, you know, what, what's,
what the pattern is that'scausing the problems and like
(13:06):
what the, the treatment is thatwill resolve it. And so you can
imagine just from like thetracking and assessment
standpoint, those are kind offormulaic questions that can be
done, collected very well , um,you know, through a digital
device. And then there's a lotof sort of calculation of
(13:27):
different aspects of thetreatment. So, you know, one
thing you wanna focus on iscorrecting a patient's sleep
window such that they'regetting into bed at the best
time for them and they'regetting outta bed the right
time, and we're trying to dothings to compress their sleep
so they get more consolidatedsleep, which is one of the big
problems insomnia, is peopletend to, you know, sort of get
(13:49):
fragmented sleep and have ahard time falling asleep or
waking up, et cetera . And soit's really, we're using that
the data, we're collecting thedevice to then recommend a
sleep window and then to coachpeople within the device around
how to use the sleep window.
Uh, and then, you know, if theywake up in the night or have
trouble falling asleep, wewanna have real time techniques
(14:11):
that they can use in thosemoments to facilitate , uh,
falling back asleep or doingthings that would reduce the
anxiety or tension that are,you know, causing the insomnia.
Uh, so it's all to say thoseare, none of those things are
things that would occur, likewhile you're in a therapist's
office,
kind of this iterative datafeedback loop as well. And they
(14:33):
are, they also require thepatient to take actions , um,
and reduce specific things andmoments in time. And so it
just, it just lends itself verywell to a digital format. Um,
but one thing I wanna add aboutthat is that doesn't, that does
not mean that there aren'taspects of a, a therapeutic
process that are not solvedwell by the digital device per
(14:55):
se. Like you can imagine what'snot present in what I just
described is like thattherapist giving you that warm
support and telling you like,this is so hard. I know this is
so hard, like, here , let me,let me talk to you about how
you can get through this ormake this like, really like
practical. Um, but I think thatthose, so it's not to say that
you, you, you can't combinegreat human delivered therapy
(15:18):
with these types of treatments,but the flip side is that no
one really wants to talk aboutinsomnia, right? If you imagine
like, you don't, people don't,people don't say, God, I can't
wait to talk to my therapistabout Sonia
there's this, like, there'sreally like the part that the
device does really well, andthen there's the part that like
an actual human provider can doreally well. And I think that's
(15:40):
where there's some real magicaround getting people great
outcomes and also , um, youknow, getting them emotional
support or other things neededfrom a therapist at the same
time.
Speaker 3 (15:50):
Yeah, that's great .
I mean, that was really gonnabe one of my next questions was
like, obviously you're apracticing , uh, clinical
psychologist , um, uh, not justa , uh, an executive and , and
develop and , and medicalofficer. Um, how , how do you,
like, as in your own practice,like if you had, if you , I
don't know if you stillmaintain a private practice,
(16:12):
but if you, if you had apractice, how would you deploy
this, these tools , uh, insupport of your patients?
Speaker 4 (16:19):
Yeah, I am still practicing. It's a small
practice given my other timecommitments. The way that I
deploy them and recommendothers deploy them are in a
couple ways. So I would say oneis for someone like me that's
like, I'm a CBT expertclinician, I use them as
reinforcers to what I'm doingwith patients in practice. And
(16:41):
so, like, I might be workingwith them on aspects of their
sleep and insomnia or aspectsof anxiety, and I could still
refer them to , uh, sleepio ordaylight to help them to
compliment what we're doing inperson to practice it outta
session, to collect the dataoutta session, give me, I , I
see the data feedback back onhow they're doing and what's
working, what's not working, etcetera. So that's one option.
(17:04):
Um, but another, if youimagine, you know, a primary
care physician who , uh, isseeing a lot of patients is
not, doesn't , is probably notreally trained in CBT, nor has
the time to provide CBT forpatients or, you know, or other
evidence-based , um, uh,behavioral approaches. And so
(17:24):
that type of provider canreally use a pro , uh, like a
program like programs like oursto compliment what , what
they're doing and, and makesure that they have, they can
actually get their patientaccess to the first line
evidence-based treatmentapproach for insomnia versus
the only option they have intheir toolkit being medication.
(17:44):
And so that's a , it is like a,it's very significant that I
would say , uh, the, thenumber, if you think about
mental health, the conditionsof mental health show up across
all different types of caresettings. And many, many of
those practitioners are not ,um, the ones that can provide
(18:07):
some of these techniques, someof these approaches. And so
there's these big access gapsand it's, you know, typically
patients have to wait months ,uh, on wait list to get access
to CBT. It's also quiteexpensive to do it in person .
And so there's a, the , theultimately treatments like this
can be a way for people to getmuch faster access and have a
(18:29):
provider overseeing the care,but the provider doesn't have
to be an expert c you know, CBTpractitioner themselves.
Speaker 3 (18:35):
Yeah. They just need to have the empathy to
understand the, you know, someof the difficulties that go
through , uh, that, that, thatour attendant in going through
such , uh, therapy. Um, yeah,no, I , the way that I, I've
always thought about it was,you know, in, in , um, you
(18:56):
know, in, in like 12 stepprograms, like in AA or , or
na, I sort of have alwaysconsidered those to be
basically like self deliveredCBT , uh, programs. And the
sponsor is really someone whois just a , um, an emotional
support person to the, to theparticipant because of how
(19:17):
uncomfortable it can be attimes to restructure your
thought patterns. Like it'snot, it's not the easiest walk
in the park. This isn't justsort of affirmation, it is ,
uh, cognitive change skillschange, which like working out
at the gym can
Speaker 4 (19:34):
Yeah, absolutely.
Speaker 3 (19:35):
Yeah. Well, that's, that's really fascinating. So ,
um, you , you know, you sort ofalluded to this, but I think
from a regulatory perspective,it's helpful to maybe step back
for our , our legal andregulatory audience, you know,
and you know, the, the, thereis an FDA approval pathway
where digital therapeutics areregulated by as a medical
(19:57):
device. And then CMS hasrecently issued a physician fee
schedule , uh, codes , uh, Gcodes under the
program for coverage , uh,incident two , uh, professional
services. Um, and, and on the ,uh, on the FDA side, you know,
you, you mentioned that therereally is a requirement to
(20:19):
demonstrate effectiveness andsafety as well as some other
very specific software specificcriteria that they've developed
, um, to support this industry.
I was wondering if you could,obviously, you mentioned some
of these tools from Big Healthhave been out there for a while
, but could you talk a littlebit about the studies that you
guys ran and sort of like howthe study process goes on
(20:43):
safety and effectiveness?
Speaker 4 (20:45):
Yeah , absolutely.
So, I mean, big Health wasfounded by , uh, one clinical
psychologist and researcher. Soone of the, the co-founders ,
um, is a sleep clinician andresearcher. And so, and, and
I'm a clinician and researchermyself as well. And so from the
very beginning, we were alwaysvery focused on the importance
(21:09):
of demonstrating safety andefficacy in good clinical
research. And interestingly,when we started out , um, it
was early in like , I think2010 , uh, there FDA was not
regulating in this space. Itdidn't exist. This was, that
was pre-digital therapeuticterminology. So , um, this is,
you know, it's been a , it'sbeen an evolving space , um,
(21:30):
which is super interesting toreflect on. And so we, we
actually spent a long time ,um, you know, providing our
therapeutics in different,different settings from
populations publishing lotresearch. We basically early on
created a scientific set ofprinciples around making our
(21:50):
products as, as , um, sort offreely available to researchers
that would do high qualityresearch on them . And as a
result , um, just sleep . Imean, sleepio and Daylight have
both been in many, many studiesas Spark as well, the
Depression program. Um, butyeah, I think, I think SLEEPIO
is in like over 40, has likeover 45 published clinical
(22:11):
trials on it at this point. Soat the point that the FDA
started regulating in thespace, and we started thinking
about, you know, wanting to getFDA clearance and going down
that pathway, we already had areally large evidence base.
Then it still was aninteresting discussion to sort
of align with FDA'sexpectations around, well, what
(22:33):
is, what are their criteria forthese new class of treatments?
Which, as you mentioned, they,they consider medical devices,
so software's, medical devices,and, and it , and it gets kind
of nuanced at that pointbecause FDA medical devices
have, you know, kind ofdifferent standards for whether
it's like a de novo applicationor , um, a five 10 K, which,
(22:54):
you know, follows a , apredicate device. Um, but in
either case, there arerequirements for clinical
safety and efficacy, but it'sthe , you know, it could be
originally in de Novo's case,you know, you're sort of
proving the original , um, theoriginal case of efficacy
versus five 10 K , it's moreabout showing substantial
(23:14):
equivalence to the predic to apredicate device. Uh, and so
for big health, there wasalready an existing FDA
classification, which I'm notgonna be able to rattle off the
number for right
could pull it up if, if
ultimately it was forcomputerized behavior therapy
for psychiatric disorders. Andour , our understanding is FDA
(23:38):
intended that classification assort of an umbrella code that
any digital therapeuticstreating psychiatric disorders
could theoretically fall underand submit applications under.
And so that's what we did. Andso therefore for us, the , the
, this expectation was showingsubstantial equivalence to
devices that had already beencleared in that, in that
category. And to be honest ,um, it, you know , it was , we
(24:02):
thought it was a appropriatelyhigh bar , uh, because the,
there were similar productdevices to what we had that,
you know, had, had greatresults against a rigorous ,
rigorous control condition. Um,so, you know, the in, in
medicine, the standard isconducting a randomized
controlled trial , uh, which wethink is, which we think is ,
(24:23):
uh, appropriate. And so we, youknow, that's what we had to
show and de and use to, to showsafety advocacy for, for FDA
clearance. And, you know,fortunately, like I said, we'd,
we'd been doing our CTS formany, many years, so we
actually had , um, many, manyconsistently replicating
efficacy, but still, there'sFDA requires very, very
(24:46):
specific requirements for otherclinical trials . So we did
actually for both Sleepio anddaylight conduct additional
separate trials that werespecifically , um, under all of
the exact controls needed forFDA . So we did, you know,
there is , there was an extramile we did even for FDA , even
after having that rigorousevidence base .
Speaker 3 (25:05):
That's great. Yeah, no, I , I think in , um, uh, it
, you know, I work with anumber of , uh, specialty
societies and development ofnew clinical , uh, procedures.
And I can say that, you know,in , in many ways, having like
rigorous third party oversightof safety and efficacy of any ,
uh, of any procedure is, isessential for ensuring that
(25:28):
that patients have access tothat , that they know that what
they're, they're buying isgonna work. And that when , uh,
'cause you can, if, you know,if you don't have that, people
won't have any credibility init. You have other regulators
coming in to prohibit things.
It's, it's really essential forthe, the sustaining of
advancement. So I that's,that's really fascinating.
Speaker 4 (25:49):
Yeah, and you can actually , can I just, I was
gonna , one thing, maybe I wasbeing sort of like , um, high
level , but I was realizing, II maybe worth clarifying it,
you know, we actually , um, youknow, we, in our research we
had shown , uh, outcomes thatwere, you know, it's really
(26:10):
relatively on par with standardof care. And as a result, we
had sleepio, for example, hasbeen recommended in clinical
treatment guidelines, firstline ahead of medication in a
number, a number of differentguidelines in the US and the
uk. And that actually happenedprior to FDA clearance. And so
it was very interesting becauseit's, we still with FDA , it's
(26:32):
still a very, it's a veryspecific requirement around
kind of matching to, you know,predicate research and other PO
and other things. So , um, itis, I do, this is all to say
like, I do think that FDA isnot, FDA is a , is a very
important , um, stakeholder inthis. I do think that evidence,
(26:55):
clinical evidence ultimately inmany cases needs to go beyond
just what's required for FDA .
And so I didn't wanna , Ididn't wanna like, you know,
inadvertently suggest that thatall you, you know, all that's
needed is your clinical trialto kind of get through FDA
clearance.
Speaker 3 (27:09):
No, and I , I think that's actually a perfect segue
to kind of the next question.
'cause I know that you've beeninvolved with the , uh, you
know, American psychiatric ,uh, association and oh , no ,
pardon me, the AmericanPsychological Association,
gotta get your APAs correct.
um, you know , uh, obviously alot of specialty societies in
(27:33):
medicine develop , uh, theirown clinical standards based on
studies on efficacy and refinethem that go into clinical
coverage guidelines and arecompletely independent of
anything that the FDA doesrelated to medical devices. And
I think digital therapeutics, Ithink presents a fascinating ,
um, uh, sort , sort of like a ,a really fascinating challenge
(27:55):
to the traditional regulationof the practice of clinical
interventions in the sense thathistorically, you know, each ,
uh, state governs the practiceof professional services and
the boards regulate the scopeof what is like within the
bounds of clinical practice.
But then national sort of , uh,societies would be responsible
(28:18):
for, or currently are kind ofempowered to set, you know,
the, the standards forreceiving , uh, certification,
you know, for , for boardcertification. And they, they
certainly publish most of theimportant clinical guidelines
that govern the practice of, ofmost , uh, of many, many actual
procedural interventions. Andwhat we're talking about is a
(28:41):
procedural intervention, but itis also , uh, regulated as
medical advice. So like , uh,uh, can you talk a little bit
about how the, like how theprofessional fields like that
is on that legacyinfrastructure of state boards,
national associations, like howit's interacting with this sort
of evolving field of clinicalinterventions?
Speaker 4 (29:02):
Yeah, absolutely.
Well, I can say to start offwith, we have had a really
important partnership with theAmerican Psychological
Association for a number ofyears now because we both
realize the importance of theother party, like big, big
health. We may have productsthat help , uh, with, with
(29:23):
people's mental health needs,but we are not the ones , um,
seeing patients and in aposition to distribute them in
a PA has the psychologists thatneed treatments like ours. And,
you know, we've been partneredon some really infor important
work advocacy work to cut , tomove the field forward. And so
I think you , um, it wasimportant for us for, I should
(29:44):
say, for both groups to makesure that the broad set of
mental health professionalswere included in , um, both ,
uh, requirements aroundauthorizing use for programs in
these areas as well as forbeing able to be reimbursed.
And so we certainly didn't wantto , um, have policies created
(30:05):
that we're going to be limiting, limiting patient access. I
mean, the whole point withwhat, you know , um, I've been
trying to do as a professional,and I think what we've been
trying to big health is toincrease access to
evidence-based mentalhealthcare , which has
historically been incrediblychallenging. And so , um, it's
(30:26):
a , so yeah, so I'd say there'sa lot of work that can be done
with professional associations,invol , you know , um, that ,
uh, represent the differenttypes of mental health
practitioners. And it's, youknow, it's not just mental
health practitioners, obviouspri you know, primary care
physicians , uh, sleep medicine, um, providers have been
reaching out to us for yearswanting to be able to
(30:49):
collaborate and use programslike ours in our practices. But
it's definitely a, it'sdefinitely a, a group exercise
as they say it
Speaker 3 (30:57):
Yeah. And I , uh, honestly, I think that's the
perfect segue into what I wouldsay is kind of my last
question. Um, I know I've takena lot of your time, but is is
really about, about the futureand sort of about how the
software can potentiallyaddress what you sort of
alluded to, which is, you know, we have a , uh, I work a lot
of mental health paritycompliance , uh, with payers
(31:17):
and sort of policy issues aboutworkforce and supply of, of
Care A and behavioral healthhas , uh, across the continuum
from like anxiety anddepression, serious mental ,
all the way up to seriousmental illness. And , uh, you
know, all across the substanceuse disorder continuum, there's
a shortage. People have chroniclack of access they cannot find
(31:38):
in-network providers. And youmentioned it earlier in the
presentation today, the cost ,uh, and delays are , uh, it's a
pervasive problem. People don'teven , uh, we, I regularly
encounter people who don't eventry to get coverage for mental
healthcare through theirtraditional insurance 'cause
they just presume that it's noteven available. Yeah. And so ,
(31:59):
uh, interested in yourperspective, like where do you
hope this will go, like in, infive or 10 years? Like how, how
will this , uh, this trend, notjust the products you guys
currently have, but the fieldoverall, like, how do you think
that this is gonna play out?
And obviously I won't hold youto it, but I would love to hear
what you would like to seehappen and where do you see it
(32:20):
going?
Speaker 4 (32:21):
Yeah, well thanks for the opportunity to project.
Uh, so I think that it's gonna, there's gonna be a big act ,
um, impact for patients andproviders and for patients. I
think the big impact is thatthey are going to have much
faster access to evidence-basedcognitive and behavioral
(32:42):
therapies. Uh, again, and therecould be some other types, but
those are, those arepredominantly the type that you
see , um, represented indigital therapeutics. So I
think they'll have fasteraccess those, what they'll be
getting will be trulyevidence-based. So it will be,
you know, they'll be, they'llbe getting a high fidelity
treatment that is shown todeliver good outcomes, and it
(33:05):
will, it allows them to havetreatment options that match
their preferences. So it's allto say that not every patient's
gonna want a digitaltherapeutic, but there are a
lot that will , um, there's alot of patient patients that do
not wanna take a medicationincreasingly these days. It's,
it's , uh, the culturalsensibilities are changing. Um,
so it , it's gonna really allowfor patients to ha have
(33:28):
different options and to havefaster access to good care ,
uh, at , at a reasonable pricepoint as well. Um, I would say
separate for providers, I thinkit's really gonna change how
they practice. And I've heard alot of enthusiasm from
different provider types abouthow this allows them to in grow
(33:51):
and improve their practice. Andso ultimately you can have
providers doing more, spendingtheir time doing what is
important for them to do. Um ,so , uh, instead of a provider
having, you know, have , havingto do everything and maybe
stretch beyond their comfortzone, if they're not, you know,
they don't feel expert in CBTfor every single condition,
(34:11):
which they, they shouldn't'cause most people are not. Um,
it allows them to do the partthat they really excel in and
then to support their patientswith additional options. And it
also, it can improve how theyuse clinician resources in a
practice. And so if you thinkabout, like, I think there's
gonna be structural changes tothinking about, well , um,
(34:34):
there we could have cliniciansand coaches that specifically
are overseeing kind of firstline access to digital
therapeutics. And then, youknow, for some patients that
don't want those or that one ,you know, need higher intensity
care, those can be referred toour specialists. And so you can
reserve like the right time forthose like small number of
(34:55):
specialists. So I think you'll,like, honestly, I think it'll,
we'll need just as many if notmore mental health
professionals , uh, and youknow, and , and , and
providers. But what they'redoing can be more aligned , um,
with what patients want, withwhat their expertise is, and
then more aligned with like theright cost base. So I think
(35:16):
they'll just be great. There'llbe growth and efficiencies that
are provided to provider, to,you know, provider groups and
health systems based on havingthis new , uh, type of care
option.
Speaker 3 (35:29):
That's really exciting. Yeah, I mean , I hope
in the, in coming years, likelearning how to use these will
be integrated into, you know ,know clinical education across
the, you know, the spectrum ofproviders , uh, from primary
care to behavioral healthpractitioners. 'cause I think,
you know, like many of the newtools, like even using a AI in
(35:50):
the workplace, like I thinklearning to use these tools is
gonna hopefully become like acore professional competency ,
uh, of any , uh, clinician. So, uh, that's super exciting.
And Jenna, well, I just gottathank you again so much for
taking the time to jump on thepodcast and , um, uh, wanna
plug again the HLA behavioralpractice group , uh, the , they
(36:11):
supported me and , uh, uh,getting this podcast together.
And , uh, thank you all forlistening.
Speaker 5 (36:17):
Thanks so much, Kevin.
Speaker 2 (36:24):
Thank you for listening. If you enjoyed this
episode, be sure to subscribeto ALA's speaking of health law
wherever you get your podcasts.
To learn more about a HLA andthe educational resources
available to the health lawcommunity, visit American
health law.org.
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