Trends in Digital Therapeutics

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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Transcript

Speaker 1: 0:00

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Speaker 2: 0:04

ALA's, popular Health Law Daily email newsletter is now a daily podcast exclusively for a HLA premium members. Get all your health law news from the major media outlets on this new podcast. To subscribe and add this private podcast, feed to your podcast app, go to American health law.org/daily podcast .

Speaker 3: 0:27

Hello and welcome , uh, to another a l , a podcast. Uh, my name is Kevin Malone. I'm, I'm excited to host the podcast today on digital therapeutics and mental health. Um, I'm a partner at Epstein Becker Green, and I'm a proud participant in the Behavioral Health practice group at A HLA. Uh, we at the Practice Group have been doing a lot to produce content related to , uh, all of the many developments in mental health , uh, treatment , uh, uh, patient needs, coverage and payment policy , uh, all of the, the emerging trends in health law for behavioral health. And today we're, we have a really great 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 Officer at Big Health, and she's a practicing clinical psychologist who specializes in research and treatment of anxiety, depression, insomnia, and other mental health conditions. Um, and she leads the , uh, company's strategy on, in an interesting industry leading body of , uh, new digital therapeutic tr treatments, including sleepio, daylight and Spark rx. And today we're gonna talk about what they are doing at Big Health and what's happening in digital therapeutics in general. Uh, if you're not familiar with what we're even talking about today, of course Jenna will , uh, uh, really illuminate this much more than I can. But in short, digital therapeutics are software-based interventions that prevent, manage, or treat medical conditions. And we're really gonna be focusing today on developments in the use of digital therapeutics for mental health services. You know, as someone who represents payers, providers, trade associations, regulators on , uh, developments in mental health, and someone who's worked in mental health policy for a long time. I think some of these developments are incredibly exciting. It's potentially gonna transform the way in which we , uh, receive mental health care and interact even with , um, you know, traditional mental health. So it's gonna be a great conversation. Jenna, thank you so much for being with me today. I just , uh, thank you for sharing your time with us.

Speaker 4: 2:39

Thank you so much for having me, Kevin. Great to be here .

Speaker 3: 2:42

So, to start off with, you know, I, I gave probably like a , you know , uh, digital Therapeutics for Dummies explanation about what it is . But if you could just take a few minutes and explain as a real professional in the field what digital therapeutics are.

Speaker 4: 2:56

Yeah, well, you did a great job, actually. So the technical definition is that it is software that is delivering the intervention. So it is a true treatment. It is that is either preventing treating or curing a disease or medical condition, and it is the software that is functioning as that treatment. So that's kind of the core of the definition. Now, what that means in practice is that it is regulated on under FDA , under FDA's , uh, jurisdiction, and there are a number of requirements for a , uh, digital therapeutic for four software as a medical device that have to be met in order for it to kind of achieve the standard that is re that it's required. So there are essentially requirements on the quality of the software , uh, development process and controls that make sure that it changes the software are , um, safe and have been tested, et cetera. There are requirements around cybersecurity and things to make sure that those risks are, are minimized. And then, of course, as you, as you know, everyone is , I think, more familiar with, there are requirements around demonstrating safety and efficacy through clinical research. And so all of those are things that are also required and part of being a digital therapeutic. So I'll stop there and see if that, that this was quite technical, so happy to like elaborate.

Speaker 3: 4:26

No, and , and I mean, it , it , it , I think that's perfect. I mean, the audience , uh, through the HLA is a lot of healthcare regulatory nerds. So it's , uh, you're in safe. Uh, we're in safe territory here and getting, getting technical. And , uh, I'll ask some questions actually a little bit later about the way , uh, the sort of FDA is approaching clinical studies on effectiveness and safety. But I think maybe we can just talk for a few minutes about some practicals on the, on the products that you guys run out of big health and sort of what the , um, what the actual conditions are. And sort of maybe a little bit as a clinician, if you could talk through like some of the , um, uh, the way the clinical intervention works for a patient , um, and, and sort of how your different products , um, actually deliver this clinical care.

Speaker 4: 5:16

Yeah, absolutely. So at Big Health, we have digital therapeutics for insomnia, anxiety, and depression. And for our products, they are based on a type of behavioral treatment model, which is called cognitive behavioral therapy, or often referred to as CBT. And that is, that's essentially a , a type of treatment that is based on helping people make changes in , uh, negative patterns of thinking and behavior that are like fundamentally the cause of, or maintaining the clinical condition, like the insomnia, for example. And that can, this is something you're familiar with, I think it actually makes a lot of , it makes a lot of sense. Um, but if you, if you haven'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. But actually , uh, mental health conditions, a lot of chronic phy physical disease conditions are largely caused and maintained by behavioral patterns or lifestyle patterns or , um, you know, including men mental , um, activities . So ultimately the, you know, one of the leading evidence-based treatment models for many , for many conditions, but particularly mental health, is co cognitive behavioral , um, based , may based methods. And so what we've done at Big Health 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 a psychologist, could also be a psychiatrist. Um, there's other types of mental health professionals, but typically these are interventions that are, they're structured, they're skill-based, and they're delivered over a period of weeks , um, meet, you know, typically meeting with a patient and then following up with them , um, to provide homework to practice the skills. It turns out that these types of tech types of treatments are really amenable to digitizing. You can, you know, in fact, like a lot of the aspects of the learning the skills and applying them in your daily life and this , you know, need the structure needing to capture data is like great in digital format. And so that's really what we've done is create these fully automated software based interventions that are walking people through these cognitive and behavioral skills that they need to, that they can adopt, that are gonna address the roots of their problems with, you know, insomnia, anxiety , depression, the , so the programs are fully automated, they're patient facing , um, people tend to use them for , uh, around two to three months, and it's really about learning new skills and then practicing them in your real world environment. Uh, and we have a , so our program for insomnia is called sleepio rx. Um, we have a program program for daylight , uh, sorry, for, for generalized anxiety disorders called Daylight rx. And these are programs that have been around , um, for a long time and while, and evidenced, and we recently took them through FDA clearance as well to really ensure , um, that they have that level of , um, you know, authorization and, and, and , uh, overview. And it , it allows them to be offered really more through traditional healthcare pathways. So , um, yeah, let me stop there, but let , let me know if I'm, what I, what I missed, what people might wanna know more about.

Speaker 3: 8:49

Yeah, no, I think that , um, you know, many people are familiar with cognitive behavior therapy in , um, in the abstract, but I, I was actually a, a , a psychology undergrad , uh, major. And I remember like learning about CBT and sort of the theory of learning , uh, and the interaction of the, you know , the learning brain and, and behavioral patterns was like one of the greatest, like transformations in my own like , uh, adulthood even. And sort of like understanding, you know, the, the sort of paradox of our freedom as, as, as agents in the world that we are learning , uh, habitual , uh, conditioned organisms, but our awareness of those patterns actually , uh, gives us more control over them. There's this like, incredible interaction between , uh, sort of awareness of our own cognitive limitations and our own con like, you know, our, our own , um, dependencies , uh, to, to actually add more contingency , uh, in our life. And I think the, I i I , one of the reasons I wanted to do this podcast was that I, I like having thought about CBT and understand and having experienced it sort of certainly interacted with other provider types that are trying to deliver it as a package intervention of limited duration with very specific measurable outcomes of what success looks like with regards to , uh, symptom change and behavior change. Um, it seemed that software was like, especially , it might even be more effective than traditional therapy because as , as we all are talking about in the context of social media and the evolution of , uh, you know, technology and the internet in our lives, we are, we are aware of software doing this whether we like it or not. And , uh, that in some ways what you guys are doing is sort of leveraging the, like, incredible power of our interaction with technology for our , uh, for the improvement of our mental health in a way that I just think is like really extraordinary. So, I mean , uh, if you don't mind, like sort of elaborating a little bit about the way people interact with the software in a way that helps them, like recognize their own thought patterns and practice new cognitive skills in like, changing the way they interact with their own thoughts.

Speaker 4: 11:19

Yeah, absolutely. Yeah, no, it , I mean, honestly, I could , uh, nerd out <laugh> a lot. Um, it's quite fascinating I think when you, when you realize that changing your behavior actually changes your biology, right? People , it's, it we, for whatever reason in modern day, I think we had , uh, we were more of this mindset that like, oh, the only way to change biology is to change biology, but actually behavior environment, it all changes biology. And so it just means that people can really be the agents of their, their own change and their own health in a far more deep way than I think we may have previously thought. And that is really what CBT does. And I think to your point , um, it can be really helpful in a more structured way and in a way that reaches people at moments of their life where they need to be making changes. And so it , it ultimately, cognitive behavioral therapy is very structured, and it is because you need to, and so I maybe just take , take for example, our program sleepio, which is for insomnia , um, to treat insomnia, you really wanna understand what the root causes of insomnia are for that person. And then you wanna provide specific interventions to change the areas that are causing the problem. And so the way that you do that in practice is through collecting a lot of information around the sleep patterns, around the thinking patterns people have around their sleep. And once you do that, you can put together what we call in clinically a case formulation of, you know, what, what's, what the pattern is that's causing the problems and like what the, the treatment is that will resolve it. And so you can imagine just from like the tracking and assessment standpoint, those are kind of formulaic questions that can be done, collected very well , um, you know, through a digital device. And then there's a lot of sort of calculation of different aspects of the treatment. So, you know, one thing you wanna focus on is correcting a patient's sleep window such that they're getting into bed at the best time for them and they're getting outta bed the right time, and we're trying to do things to compress their sleep so they get more consolidated sleep, which is one of the big problems insomnia, is people tend to, you know, sort of get fragmented sleep and have a hard time falling asleep or waking up, et cetera . And so it's really, we're using that the data, we're collecting the device to then recommend a sleep window and then to coach people within the device around how to use the sleep window. Uh, and then, you know, if they wake up in the night or have trouble falling asleep, we wanna have real time techniques that they can use in those moments to facilitate , uh, falling back asleep or doing things that would reduce the anxiety or tension that are, you know, causing the insomnia. Uh, so it's all to say those are, none of those things are things that would occur, like while you're in a therapist's office, <laugh>. And , uh, there are things that require kind of this iterative data feedback loop as well. And they are, they also require the patient to take actions , um, and reduce specific things and moments in time. And so it just, it just lends itself very well to a digital format. Um, but one thing I wanna add about that is that doesn't, that does not mean that there aren't aspects of a, a therapeutic process that are not solved well by the digital device per se. Like you can imagine what's not present in what I just described is like that therapist 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 or make this like, really like practical. Um, but I think that those, so it's not to say that you, you, you can't combine great human delivered therapy with these types of treatments, but the flip side is that no one really wants to talk about insomnia, right? If you imagine like, you don't, people don't, people don't say, God, I can't wait to talk to my therapist about Sonia <laugh> . So there's this, like, there's really like the part that the device does really well, and then there's the part that like an actual human provider can do really well. And I think that's where there's some real magic around getting people great outcomes and also , um, you know, getting them emotional support or other things needed from a therapist at the same time.

Speaker 3: 15:50

Yeah, that's great . I mean, that was really gonna be one of my next questions was like, obviously you're a practicing , uh, clinical psychologist , um, uh, not just a , uh, an executive and , and develop and , and medical officer. Um, how , how do you, like, as in your own practice, like if you had, if you , I don't know if you still maintain a private practice, but if you, if you had a practice, how would you deploy this, these tools , uh, in support of your patients?

Speaker 4: 16:19

Yeah, I am still practicing. It's a small practice given my other time commitments. The way that I deploy them and recommend others deploy them are in a couple ways. So I would say one is for someone like me that's like, I'm a CBT expert clinician, I use them as reinforcers to what I'm doing with patients in practice. And so, like, I might be working with them on aspects of their sleep and insomnia or aspects of anxiety, and I could still refer them to , uh, sleepio or daylight to help them to compliment what we're doing in person to practice it outta session, to collect the data outta session, give me, I , I see the data feedback back on how they're doing and what's working, what's not working, et cetera. So that's one option. Um, but another, if you imagine, you know, a primary care physician who , uh, is seeing a lot of patients is not, doesn't , is probably not really trained in CBT, nor has the time to provide CBT for patients or, you know, or other evidence-based , um, uh, behavioral approaches. And so that type of provider can really use a pro , uh, like a program like programs like ours to compliment what , what they're doing and, and make sure that they have, they can actually get their patient access to the first line evidence-based treatment approach for insomnia versus the only option they have in their toolkit being medication. And so that's a , it is like a, it's very significant that I would say , uh, the, the number, if you think about mental health, the conditions of mental health show up across all different types of care settings. And many, many of those practitioners are not , um, the ones that can provide some of these techniques, some of these approaches. And so there's these big access gaps and it's, you know, typically patients have to wait months , uh, on wait list to get access to CBT. It's also quite expensive to do it in person . And so there's a, the , the ultimately treatments like this can be a way for people to get much faster access and have a provider overseeing the care, but the provider doesn't have to be an expert c you know, CBT practitioner themselves.

Speaker 3: 18:35

Yeah. They just need to have the empathy to understand the, you know, some of the difficulties that go through , uh, that, that, that our 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 know, in, in like 12 step programs, like in AA or , or na, I sort of have always considered those to be basically like self delivered CBT , uh, programs. And the sponsor is really someone who is just a , um, an emotional support person to the, to the participant because of how uncomfortable it can be at times to restructure your thought patterns. Like it's not, it's not the easiest walk in the park. This isn't just sort of affirmation, it is , uh, cognitive change skills change, which like working out at the gym can <laugh> can be painful. 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 of alluded to this, but I think from a regulatory perspective, it's helpful to maybe step back for our , our legal and regulatory audience, you know, and you know, the, the, there is an FDA approval pathway where digital therapeutics are regulated by as a medical device. And then CMS has recently issued a physician fee schedule , uh, codes , uh, G codes under the <INAUDIBLE> 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 there really is a requirement to demonstrate effectiveness and safety as well as some other very specific software specific criteria that they've developed , um, to support this industry. I was wondering if you could, obviously, you mentioned some of these tools from Big Health have been out there for a while , but could you talk a little bit about the studies that you guys ran and sort of like how the study process goes on safety and effectiveness?

Speaker 4: 20:45

Yeah , absolutely. So, I mean, big Health was founded by , uh, one clinical psychologist and researcher. So one of the, the co-founders , um, is a sleep clinician and researcher. And so, and, and I'm a clinician and researcher myself as well. And so from the very beginning, we were always very focused on the importance of demonstrating safety and efficacy in good clinical research. And interestingly, when we started out , um, it was early in like , I think 2010 , uh, there FDA was not regulating in this space. It didn't exist. This was, that was pre-digital therapeutic terminology. So , um, this is, you know, it's been a , it's been an evolving space , um, which is super interesting to reflect on. And so we, we actually spent a long time , um, you know, providing our therapeutics in different, different settings from populations publishing lot research. We basically early on created a scientific set of principles around making our products as, as , um, sort of freely available to researchers that would do high quality research on them . And as a result , um, just sleep . I mean, sleepio and Daylight have both been in many, many studies as Spark as well, the Depression program. Um, but yeah, I think, I think SLEEPIO is in like over 40, has like over 45 published clinical trials on it at this point. So at the point that the FDA started regulating in the space, and we started thinking about, you know, wanting to get FDA clearance and going down that pathway, we already had a really large evidence base. Then it still was an interesting discussion to sort of align with FDA's expectations around, well, what is, what are their criteria for these 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 point because FDA medical devices have, you know, kind of different standards for whether it's like a de novo application or , um, a five 10 K, which, you know, follows a , a predicate device. Um, but in either case, there are requirements for clinical safety and efficacy, but it's the , you know, it could be originally in de Novo's case, you know, you're sort of proving the original , um, the original case of efficacy versus five 10 K , it's more about showing substantial equivalence to the predic to a predicate device. Uh, and so for big health, there was already an existing FDA classification, which I'm not gonna be able to rattle off the number for right <laugh> , I realize I should , I could, I could pull it up if, if <inaudible> , but it was , um, ultimately it was for computerized behavior therapy for psychiatric disorders. And our , our understanding is FDA intended that classification as sort of an umbrella code that any digital therapeutics treating psychiatric disorders could theoretically fall under and submit applications under. And so that's what we did. And so therefore for us, the , the , this expectation was showing substantial equivalence to devices that had already been cleared in that, in that category. And to be honest , um, it, you know , it was , we thought it was a appropriately high bar , uh, because the, there were similar product devices to what we had that, you know, had, had great results against a rigorous , rigorous control condition. Um, so, you know, the in, in medicine, the standard is conducting a randomized controlled trial , uh, which we think is, which we think is , uh, appropriate. And so we, you know, that's what we had to show and de and use to, to show safety advocacy for, for FDA clearance. And, you know, fortunately, like I said, we'd, we'd been doing our CTS for many, many years, so we actually had , um, many, many consistently replicating efficacy, but still, there's FDA requires very, very specific requirements for other clinical trials . So we did actually for both Sleepio and daylight conduct additional separate trials that were specifically , um, under all of the exact controls needed for FDA . So we did, you know, there is , there was an extra mile we did even for FDA , even after having that rigorous evidence base .

Speaker 3: 25:05

That's great. Yeah, no, I , I think in , um, uh, it , you know, I work with a number of , uh, specialty societies and development of new clinical , uh, procedures. And I can say that, you know, in , in many ways, having like rigorous third party oversight of safety and efficacy of any , uh, of any procedure is, is essential for ensuring that that patients have access to that , that they know that what they're, they're buying is gonna work. And that when , uh, 'cause you can, if, you know, if you don't have that, people won't have any credibility in it. You have other regulators coming in to prohibit things. It's, it's really essential for the, 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 was being sort of like , um, high level , but I was realizing, I I maybe worth clarifying it, you know, we actually , um, you know, we, in our research we had shown , uh, outcomes that were, you know, it's really relatively on par with standard of care. And as a result, we had sleepio, for example, has been recommended in clinical treatment guidelines, first line ahead of medication in a number, a number of different guidelines in the US and the uk. And that actually happened prior to FDA clearance. And so it was very interesting because it's, we still with FDA , it's still a very, it's a very specific requirement around kind of matching to, you know, predicate research and other PO and other things. So , um, it is, I do, this is all to say like, I do think that FDA is not, FDA is a , is a very important , um, stakeholder in this. I do think that evidence, clinical evidence ultimately in many cases needs to go beyond just what's required for FDA . And so I didn't wanna , I didn't wanna like, you know, inadvertently suggest that that all you, you know, all that's needed is your clinical trial to 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 been involved with the , uh, you know, American psychiatric , uh, association and oh , no , pardon me, the American Psychological Association, gotta get your APAs correct. <laugh>, that's the worst kind of mistake to make. Um, and , um, you know , uh, obviously a lot of specialty societies in medicine develop , uh, their own clinical standards based on studies on efficacy and refine them that go into clinical coverage guidelines and are completely independent of anything that the FDA does related to medical devices. And I think digital therapeutics, I think presents a fascinating , um, uh, sort , sort of like a , a really fascinating challenge to the traditional regulation of the practice of clinical interventions in the sense that historically, you know, each , uh, state governs the practice of professional services and the boards regulate the scope of what is like within the bounds of clinical practice. But then national sort of , uh, societies would be responsible for, or currently are kind of empowered to set, you know, the, the standards for receiving , uh, certification, you know, for , for board certification. And they, they certainly publish most of the important clinical guidelines that govern the practice of, of most , uh, of many, many actual procedural interventions. And what we're talking about is a procedural intervention, but it is also , uh, regulated as medical advice. So like , uh, uh, can you talk a little bit about how the, like how the professional fields like that is on that legacy infrastructure of state boards, national associations, like how it's interacting with this sort of evolving field of clinical interventions?

Speaker 4: 29:02

Yeah, absolutely. Well, I can say to start off with, we have had a really important partnership with the American Psychological Association for a number of years now because we both realize the importance of the other party, like big, big health. We may have products that help , uh, with, with people's mental health needs, but we are not the ones , um, seeing patients and in a position to distribute them in a PA has the psychologists that need treatments like ours. And, you know, we've been partnered on some really infor important work advocacy work to cut , to move the field forward. And so I think you , um, it was important for us for, I should say, for both groups to make sure that the broad set of mental health professionals were included in , um, both , uh, requirements around authorizing use for programs in these areas as well as for being able to be reimbursed. And so we certainly didn't want to , um, have policies created that we're going to be limiting , limiting patient access. I mean, the whole point with what, you know , um, I've been trying to do as a professional, and I think what we've been trying to big health is to increase access to evidence-based mental healthcare , which has historically been incredibly challenging. And so , um, it's a , so yeah, so I'd say there's a lot of work that can be done with professional associations, invol , you know , um, that , uh, represent the different types of mental health practitioners. And it's, you know, it's not just mental health practitioners, obvious pri you know, primary care physicians , uh, sleep medicine , um, providers have been reaching out to us for years wanting to be able to collaborate and use programs like ours in our practices. But it's definitely a, it's definitely a, a group exercise as they say it <laugh> .

Speaker 3: 30:57

Yeah. And I , uh, honestly, I think that's the perfect segue into what I would say is kind of my last question. Um, I know I've taken a lot of your time, but is is really about, about the future and sort of about how the software can potentially address what you sort of alluded to, which is, you know , we have a , uh, I work a lot of mental health parity compliance , uh, with payers and sort of policy issues about workforce and supply of, of Care A and behavioral health has , uh, across the continuum from like anxiety and depression, serious mental , all the way up to serious mental illness. And , uh, you know, all across the substance use disorder continuum, there's a shortage. People have chronic lack of access they cannot find in-network providers. And you mentioned it earlier in the presentation today, the cost , uh, and delays are , uh, it's a pervasive problem. People don't even , uh, we, I regularly encounter people who don't even try to get coverage for mental healthcare through their traditional insurance 'cause they just presume that it's not even available. Yeah. And so , uh, interested in your perspective, like where do you hope this will go, like in, in five or 10 years? Like how, how will this , uh, this trend, not just the products you guys currently have, but the field overall, like, how do you think that this is gonna play out? And obviously I won't hold you to it, but I would love to hear what you would like to see happen and where do you see it 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 and providers and for patients. I think the big impact is that they are going to have much faster access to evidence-based cognitive and behavioral therapies. Uh, again, and there could be some other types, but those are, those are predominantly the type that you see , um, represented in digital therapeutics. So I think they'll have faster access those, what they'll be getting will be truly evidence-based. So it will be, you know, they'll be, they'll be getting a high fidelity treatment that is shown to deliver good outcomes, and it will, it allows them to have treatment options that match their preferences. So it's all to say that not every patient's gonna want a digital therapeutic, but there are a lot that will , um, there's a lot of patient patients that do not wanna take a medication increasingly these days. It's, it's , uh, the cultural sensibilities are changing. Um, so it , it's gonna really allow for patients to ha have different options and to have faster access to good care , uh, at , at a reasonable price point as well. Um, I would say separate for providers, I think it's really gonna change how they practice. And I've heard a lot of enthusiasm from different provider types about how this allows them to in grow and improve their practice. And so ultimately you can have providers doing more, spending their time doing what is important for them to do. Um , so , uh, instead of a provider having, you know, have , having to do everything and maybe stretch beyond their comfort zone, if they're not, you know, they don't feel expert in CBT for every single condition, which they, they shouldn't 'cause most people are not. Um, it allows them to do the part that they really excel in and then to support their patients with additional options. And it also, it can improve how they use clinician resources in a practice. And so if you think about, like, I think there's gonna be structural changes to thinking about, well , um, there we could have clinicians and coaches that specifically are overseeing kind of first line access to digital therapeutics. And then, you know, for some patients that don't want those or that one , you know, need higher intensity care, those can be referred to our specialists. And so you can reserve like the right time for those like small number of specialists. So I think you'll, like, honestly, I think it'll, we'll need just as many if not more mental health professionals , uh, and you know, and , and , and providers. But what they're doing can be more aligned , um, with what patients want, with what their expertise is, and then more aligned with like the right cost base. So I think they'll just be great. There'll be growth and efficiencies that are provided to provider, to, you know, provider groups and health systems based on having this new , uh, type of care option.

Speaker 3: 35:29

That's really exciting. Yeah, I mean , I hope in the, in coming years, like learning how to use these will be integrated into, you know , know clinical education across the, you know, the spectrum of providers , uh, from primary care to behavioral health practitioners. 'cause I think, you know, like many of the new tools, like even using a AI in the workplace, like I think learning to use these tools is gonna hopefully become like a core professional competency , uh, of any , uh, clinician. So , uh, that's super exciting. And Jenna, well, I just gotta thank you again so much for taking the time to jump on the podcast and , um, uh, wanna plug again the HLA behavioral practice group , uh, the , they supported me and , uh, uh, getting this podcast together. And , uh, thank you all for listening.

Speaker 5: 36:17

Thanks so much, Kevin.

Speaker 2: 36:24

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