Welcome, everyone, to Digital Health Technologies, What You Need to Know. And there's a couple of initial disclaimers we were asked to give. One of them is, if you have any questions, please use the microphones. And the other thing is we don't have a clicker, so unfortunately, I think we're stuck to over here. But please consider this that we like to move around more usually. This is a talk that basically is really an open statement of there's a lot of stuff that we do not know about with digital health technologies. And so we want this to be collaborative. If you have any experience, if you have any experience using any of these, please let us know. Please don't wait until the end for questions or comments. Please, we want this to be engaging and interactive because this is really a collaborative presentation to talk about the fact that there's a lot of stuff going on very quickly. And as usual with many medical treatments, we are, as physicians, the last to be made aware of them, unfortunately. So with that being said, I'll go ahead and get started. Everybody can hear me OK? I feel like there's a huge echo. So it should be good, unless we can make it quieter. Or I suppose I could whisper, but that's not a good plan. So my name is Akiva Down. This is Sherry Neichel. It's very nice to see everybody here. And neither one of us have any relevant commercial interests or disclosures to report. We're, I guess, boring. So the objectives we want, we want everybody to be able to explain the difference between digital health, digital medicine, and digital therapeutics and be able to provide examples of each of them. We want you to be able to identify the concerns surrounding privacy protections, research, reimbursement, health equity with the use of digital health technologies. And finally, we want you to be able to create a plan to evaluate and incorporate digital health technologies into practice. It's kind of one of those things where I heard a talk a while ago from Dr. Kevin Hill. And he's a cannabis expert. And he was talking about the fact of whether we agree with it or not, the fact is it's here. So if nothing else, we need to learn about it. We need to learn to deal with it and figure out how to utilize, not necessarily utilize it, but utilize it in a way that we can at least be informed practitioners. And so I think of digital health technologies in many ways as the same. They're here. They're not going away. And so whether we choose to use them, whether we agree with them, whether you find something to be completely not a great choice, we still have to know about them. We still have to know what to do surrounding them. And so that's why it's really important. That's why we have that last objective there. Because whether or not they are here. So let's start by figuring out what everybody's baseline knowledge is about these things. So which of these is an example of digital health technology? Give everybody a minute to. Wow, that was loud. Shout it out if you haven't guessed. Yes. I heard it. Somebody say it? Perfect. All of them. Electronic health records is a digital health technology. Group therapy using telehealth is a digital technology. Even your fitness watches, your smart watches, those little rings that tell you how much you slept and whether or not you woke up in the middle of the night because you might not know, that's a digital health technology. So digital therapeutics require the same rigorous testing as other medical treatments. True or false? All right. Good. We have a wonderfully aware population. Yes. False. Digital health information is secure. True or false? Right, if you think that Google isn't watching your every step with your Google Watch or your smartwatch, think again. I'm sure it is. Digital therapeutics increase access to care. Ah, perfect. So many of you got secret answer C, which is maybe. Because the truth is that there's so many different limitations and lack of information. So you notice we have a variety of different agent experience practitioners. We have practitioners who, in the end of their career, were all of a sudden told, hey, you have to use an electronic health record now. And some of us are individuals who had never used a computer, let alone type notes. Everything was handwritten. Everything was for yourself. And then we have people who are in the new generation and the current generation of practitioners who don't know how to even write in cursive, let alone handwrite a note. If it's not a checkbox, they don't know how to fill it out. So these are the things that we don't know. Because if you have all of these things at your fingertips, but you don't know how to use them, then you don't really have them. And similarly, if you know how to use everything, but you live in rural West Virginia, which doesn't even have internet access, then you're probably not getting much use out of these digital health therapeutics. So what is digital health? Well, there's a continuum. So digital items are basically anything that we use, blockchain, so all the different cryptocurrencies, AI. There's been a lot of talks about AI and integration into psychotherapeutic treatments. We have different data pieces. Again, when you go to Google, when you go to Yahoo or Bing, these are all picking up. Facebook is picking up all of your information, even right now. My phone, at some point, is going to start advertising to me about chat GPT or other things because of everything I've been hearing. And then we have digital health, which includes electronic health records. It includes anything that is tracked and geared towards wellness. It's patient portals. So there's a requirement that patients be able to have a patient portal to access their electronic health records. And even, again, wearable trackers, smartwatches, the rings that track sleep. And then we have digital medicine. Digital medicine are digital diagnostic tools, so telemonitoring, halter monitoring. When you wear and you go home and you wear a halter monitor, that's one of them. And then we have digital therapeutics, which not only monitor, but they intervene. And in many ways, they're designed to intervene independently. So there was a presentation yesterday that talked about using AI to do psychotherapy. And it was a very interesting presentation. And one of the things that, unfortunately, I was able to take away was they were trying to show an example, and it didn't load. And so the challenge with that is it's a very real world example of the challenge with using a digital therapeutic. So we've all gotten paged or maybe a phone call where maybe we didn't get to it right away, but we got to it eventually. Now, raise your hands if you use electronic health records here. OK. And raise your hands if you've ever used electronic health records and they have completely shut down while you're trying to work on them. It's like the equivalent that we used to use when I was at one of the practices was it's like asking a surgeon to operate in the dark. We can't do it. We can try, but it's not so safe if all of your records are in this platform that you can't access. So what is digital health? Digital health is the use of technology and data analytics to understand people's health-related behaviors and provide personal health care resources. It's a very broad statement. It's very broad. What does that mean? I don't know. It kind of is a catch-all, right? And then we see we have this kind of umbrella where we have digital health, which includes digital medicine, digital therapeutics, and prescription digital therapeutics. So digital health is this blanket term. And so one of the things we want you to walk away with is to know that there is a difference between these things. Same idea as all harps are instruments, but not all instruments are harps. So all digital therapeutics fall in the category of digital health. They are designed to help with informing us about population health, with patient and clinician experience, to utilize that as a way to increase access. So one of the things that comes to my mind right away is, and this is not intentionally a plug. It just is an accidental plug for the PCSS, the Provider Clinical Support System, which is a free, government-funded way to access information on substance use treatment. I'm biased. I'm an addiction psychiatrist. I will own that right now. And so one of the things is it's an access. It's a resource to get forums, to be able to talk to people back and forth, to get information. And digital health technology is part of what makes that possible, where you no longer have to feel like you are a siloed practitioner who has to figure everything out on your own. It measures clinical outcomes. We get a lot of population data this way. And it can look at health disparities, areas where there's no practitioners available, where people are kind of, or there's practitioners available, but people, for some reason, aren't able to access them, either through the variety of different health care disparities, inequalities, all of these different things that have come up that we can see with this information to be able to say, hey, what's going on here? So they capture, store, and display information. We have the lifestyle apps, fitness trackers. And a lot of these are not necessarily medically sanctioned. Nobody's saying, oh, you know what? Your FitWatch is really going to tell me all of the information I ever need to know about your physical activity and your sleep. I mean, I remember one time I was wearing one of the fitness watches. And I was awake. And it told me I was sleeping. So I was very confused, because I was clearly awake, like walking around awake. And it said I was asleep, so not very helpful. But they give us an idea. And then we have health information technology, like a medical record. There's a lot of different medical records. I know that, in my experience alone between residency, fellowship, and afterwards, probably worked with 20 different electronic health records. I can tell you none of them worked the same way. Anybody else have a similar experience? Anybody work with more than one electronic health record in their career and find that some of them are really, really great? No, I don't know that any of them are really great. But some of them are really OK. And some of them are essentially a Word document or less. So electronic prescribing. Electronic prescribing is fantastic in many ways, except, again, let's think of another example. So class 2 narcotics, stimulants. There's a stimulant shortage right now. Anybody else finding that they're having to call multiple pharmacies, or rather electronically send multiple pharmacies, because no one will tell you where they have prescription medications for your patients? Eats up so much of your time. I find myself at times, and I know Massachusetts recently had sent out an email saying, we know that there's a shortage. So you can give a paper prescription. It's very helpful. So now my patient can run around to 17 different pharmacies looking for their prescription medication. So there are times where these things are very helpful, and times where, even in their very helpful ways, they fail us. They give us consumer health information. They let the patient access their information. And so no longer does a patient have to go to a new doctor and say, I don't know what I have. I don't know what my blood tests are. I don't know anything. Because so many times I see someone, and I didn't get their labs. Even though my fax number was on their lab slip, I never got the information. But now, thanks to patient health portals, they can tell me what their information said. And I can look it up. So it's very helpful in that way. Information transmission. So a lot of these will take information, and they'll store it. And they don't manipulate the information. They just store and transfer, put from one place to another. And it can also help with other clinical management tools. Billing services, all of them would fall into this. You send in the billing code. It gets washed out through a clearinghouse, or scrubbed, or whatever the terminology is. And then it goes to whatever insurance company for them to deny the coverage. So then we have our length of stay monitoring. So we can look, and different administrators can look in an emergency department. And they can say, oh, your average stay is 23 hours. That's not good. You guys need to be faster. Or they can look at the average wait time. And then you can have billboards that want to advertise your emergency department and say, our average wait time is three minutes. Well, that's great. So what about clinical trials and regulation? Surely, digital health technology requires evidence and oversight. No. No, it does not. What about digital medicine? What is digital medicine? It describes a field concerned with the use of technologies as tools for measurement and intervention. So now we've gone from just storing and transmitting from one place to another. So it plays a direct role in informing diagnosis and treatment. So some examples of these would be pacemakers, halter monitors, swallowed monitoring mechanisms, remote patient monitoring. And what they do is, right, some of them are pretty simple. They're just monitoring. are programmed to intervene. Now, I know that in my practice, I saw an individual who basically was seeing me for anxiety. And we found out he had a pacemaker. It was one of those auto-defibrillating pacemakers that if his heart rate got too high, it would shock him. And he was having severe anxiety every time he would play baseball. He was an avid baseball player. He was good. He was relatively physically fit. And he was having incredible anxiety playing baseball. And I said, you know, it took a history, because, right, take a history. And it turned out that he probably did have anxiety from a long time back, several different traumatic experiences. One of those gentlemen who had been taught throughout most of their life that the emotions you're allowed to have as a man are angry and not angry. And so he had never kind of been able to verbalize. But his wife came in, and of course, it was great collateral information where she would say, well, he seems a lot of different stuff. But the bottom line was, as I said, you know, I think you have anxiety. But I think you also should see the electrocardiologist to find out, is your pacemaker shocking you at inappropriate times? And lo and behold, he came back a month later. And he said, you know, my pacemaker was shocking me every time my heart rate went above 70. That'll cause anxiety, no question. So that helped significantly. And we were able to correct that issue. And then there's also user interface with these. So insulin pumps. I have a patient who also was on an insulin pump. But she was also managing her own insulin because she thought she was going to do it better than the insulin pump. And she had repeatedly ended up with hypoglycemic episodes because she would give herself insulin and so would the insulin pump. And that's not a good combo. So again, there are these challenges of not only the technology failing us, but the human aspect interfering with technology is also getting in the way. So these are definitely in those realms of challenges. And some of them do require human intervention still. All of them do pretty much, which is great because they should, because we want to have that oversight because of what I said, the issue of failing, the issue of the human failing the system, a CPAP machine, right? A, it doesn't work if you don't wear it. So it's nice that it monitors whether you've worn it or not. And B, if it doesn't have the correct seal, if it's not the correct flow and all of these things, why are we talking about it in psychiatry? Because of course, sleep apnea affects mental health. It affects physical, it affects so much more than just the quality of sleep. And so it's so important. It's imperative that we know that our patients with obstructive sleep apnea who should be on a CPAP are using their CPAP. And then sometimes we even have behavioral techniques where we talk to people about how to fit their mask make themselves more comfortable when they're wearing their mask, all of these different techniques to help out so that we can get them to wear their device. So evidence and oversight, well, they have clinical trials and kind of are regulated, sort of. Some things yes, some things no, but it's not so perfectly clear. And so now I'm gonna toss it over to Sherry to talk about digital therapeutics. Okay. Yes, go for it, yes. Measurement. I'm sorry to speak a lot about other things that maybe are unrelated to psychiatry. But how we're classifying clinical decision support tools, so like a digitized PHQ or a suicidality scale, something like that that is developed on paper as a clinical decision support tool. How would you? Can you, I'm sorry, can you? Yeah, I don't know if it's a microphone. Oh, yeah, so I was just wondering for a clinical decision support tool, so like a PHQ-9 or a suicidality scale, there were changes recently with the FDA regarding how they classify those. And so I'm just curious. I didn't see anything in this section regarding those, and I think those are pretty valuable to the audience in terms of using it on paper versus using a digitized form. And how do we look to know if this has truly been validated in a digitized form and things have been checked so they don't shut down, they don't have a bug that has to be updated? So I don't know if you have any comments regarding that. I think that, oh, go ahead, somebody. You mentioned the FDA, so you can speak to it. Yeah, so the, sorry, people aren't aware. So the FDA in 2022 September updated their clinical decision support guidance. So they changed their guidance and gave a very clear picture of what a medical device is. And clinical decision support tools, so something, it gives you four pieces that it has to follow. And one of those is that it gives you a directive. It doesn't, and it gives you recommendations. And you as the doctor, if you can't follow the algorithm, then that product can be classified as a medical device. So certain tools that we're using as doctors like for measurement-based care, if they're done in a computer or in an app would have to follow a medical device. If you just Google clinical decision support September 2022, you'll get the whole. So yeah, I don't know if I'm going to have a comment on that right now because I think we were, at least, and I'll talk about sort of how the genesis of this talk at some point was focused on digital therapeutics, which I don't think they actually fall under digital therapeutics. I will, but it'll be good because we'll have to look it up and add it in here. We are going to talk a little bit about the FDA and some thoughts about that. I do think also when we're talking about something like the PHQ-9 or the different, you know, back anxiety and all of those different things, I think that part of it is, and part of the benefit that we can look at, is these are already validated rating scales. And so was your question specifically about putting them into a digitized form? They're validated, so it's like saying, once you digitize something, you can have bugs. Your algorithm now, it's not up to the doctor. So I worked in medical devices for a long time, so that's why I'm curious about this because it seems like there's a disconnect, and maybe on the psychiatry side, it's not They're not aware that these are medical devices. Right. And I think that, I was putting this together, I thought we could have an entire workshop on how the FDA kind of comes up with it and how the FDA is different than I work for Medicaid in Delaware and how do things get approved and what does it mean. I don't know. We're not going to actually address that per se, but so I'm sorry. I think that's the... Okay, digital, so we're going to talk about digital therapeutics. Digital therapeutics, they are supposed to deliver evidence-based therapeutic interventions, treat, manage, or prevent a disorder, and they are used independently or in concert with medications, devices, or other therapies to optimize patient care. They are different from everything else that we talked about because they are approved. They have to be approved by a regulatory body, and they have to provide evidence to support their claims. So per the industry standards, digital therapeutic products should adhere to the following foundational principles. When I saw this, I had a question. What industry is setting the standards? So this is the first thing that sort of came up is who's deciding what the standards are. We did a lot of looking around to sort of figure out, and the best I came up with was the one we see here, which is the Digital Therapeutics Alliance. You can look it up. They're going to tell you all about what it is. Interestingly, they are a trade association of industry leaders and stakeholders. You can read here what they say that they are doing. When I was on their website, I was very curious to sort of see industry leaders and stakeholders. The clinicians didn't come until further in their pages of like what were the clinicians doing, and I thought it was integral in the development of what's going on, and I thought I don't know how you could develop a digital therapeutic that's supposed to treat a condition without talking to your clinicians or having them be making these decisions, but it seems to be not exactly how that is going, right? All of these have a lot of MBAs and Silicon Valley folks that are at the tops of these pages and kind of guiding where the conversation is going, which I felt was that worried me some, but these are the industry standards that they've come up with. This is what they are talking about doing, and you can see some of these that I had a problem with, right? The first few are good. Great patient privacy and security protections, we're going to talk about what that actually looks like, and you can read the rest of these here. They're going to talk about best practices and published trials, trial results, and we're going to talk a little bit about what that actually looks like because it all sounds really good on paper, but when you start pulling out what's actually happening, it will be I found it really interesting to see what it really meant, but it looks great on paper about what we're supposed to be, what these digital therapeutics are supposed to be doing. So if you look at the global digital therapeutics market, by 2030, there is almost $36 billion. It's a $36 billion business, and so there are a lot of people who want to make money doing this, and it's an interesting juxtaposition between those who are putting together software and venture capital and where that's going and what it really means to sort of take care of people, and we'll talk a little bit about that, but that's a lot of money that people are going to be jumping in to try to get. So the digital therapeutics, these are some products, and the one that I'm going to talk a little bit about, and I should probably tell you that I'll talk about this a little bit later. I got involved in this whole topic because as the I work at Medicaid in Delaware, and our legislator came to us and said, you must come to us by such and such a date and explain to us how you're going to pay for these prescription digital therapeutics that treat opioid use disorder, right? So there wasn't a request to ask what we know about them or whether we thought it was a good idea. They just sort of assumed that it would be something that we should pay for, and as I did the research, I went back and said I didn't think that we should pay for them right now. I didn't think, and we'll talk about the reasons that that was, but paratherapeutics was the one that they were looking at. So I don't know if anybody in here is using Reset or Reset-O. Does anybody have experience in prescribing these for their patients? Yeah, so it'll be interesting. Let me ask this before we start. Do you mind? What was your experience in using? I work at the VA, and I just wondered if you were going through how that actually was a little bit of a decision at the point it was supposed to be, and a little bit of a precursor to the therapy. Yep. Yeah. Oh, I will tell you, it is hilarious. The first time, I gave this talk at ASAM last month, and the week I gave it, I gave it on the Saturday. That Monday, they declared bankruptcy. But apparently, they said it was our fault in Medicaid, because we weren't paying for it, which I thought was very interesting. So that's the big... So you can already see the problem as we start to talk, is now you have all these patients that were being prescribed this intervention, and it now doesn't exist anymore. It took me a long time to find this, but it cost... What they were saying was that if you were going to prescribe this three months, so you got... Three months, it was almost $1,200. The first question that I had was, despite what people think, there's a limited amount of money. So my first thought was, if we're going to pay for this, what are we not going to pay for? So there would have to be something, and that most of the people that were using it, most of the state Medicaid... State Medicades that were using it were not disclosing how they were paying for it, and they were actually working with Paratherapeutics, right? So they were getting a deal. There was a big deal about it being FDA approved. So it got... God, this was so confusing, if anybody knows. So there was a pair reset, got reset, approved by the FDA, and it was this thing called this de novo classification. So it was for these novel medical devices that they said posed a low to moderate risk. And there's a big difference between FDA approval and, for example, when CMS decides they're going to pay for something. There's a totally different... I said you do a whole talk on that. The FDA approval, I would also like to say that OxyContin was also FDA approved. So I don't put a whole lot of stock necessarily into FDA approval, right? Because we have reset because we approved OxyContin and how we got into this mess in the first place. And I did that because I think maybe most of us might think that, but legislators and people out there were like, it's FDA approved, so it must be fabulous and we must use it because someone has said it's okay. And I don't think that that tells the whole story, which left me looking at some of what the concerns are. So the first thing that I had worried about was data and privacy issues. And we all here are quite familiar with HIPAA and 42 CFR Part 2, particularly if you do any work in substance abuse, right? That we have very strict... We are held to a high standard in terms of protecting patient information and patient confidentiality. And again, since we were looking at this reset O for opioids, we were looking at an even higher level, right? So if you're treating substance abuse, you're held to an even higher standard. So the AMA came out and said that they thought that physicians should alert patients to potential privacy risks of any mHealth apps, right? And document that the patient understands that there's a risk. So I would ask anybody here, right? Because I didn't know, but is anybody here aware of what the risks are if someone's using any of these digital health technologies, right? I see one, right? But I don't know that most of us read the fine print. So if we looked here, they had a talk back and this was in 2000. I got my reading glasses on here. So in 2020, December, 2020, there was a paper that came out that was fast and I was like, you got to be kidding. So these digital health tools are not covered entities. They don't... They're not required to protect the data by HIPAA and the Department of Health and Social Services or civil rights have purview over any of that data. So they can't or any breach of the information, right? So they're supposed to tell, but most people do not know that their information is... If it's breached, shared or sold, they're not going to find out because there is no... They don't have to tell them. There's no requirement to tell patients this. This is in 2020. And then in February of 2023, there was a report that came out of Duke and it was a big deal. So there's all these headlines about it, that data brokers and the sale of Americans' mental health data. There are brokers which advertise and are willing and able to sell data concerning America's as highly sensitive mental health information. If you look... So I pulled up a pair and you can read it all later, but there's lots of things here in the small print that basically say, well, you're giving us... By doing this, you're letting us know we're going to collect, use, retain and disclose your PI and performance with this privacy policy. I would wonder if any patient who was prescribed Reset or Reset-O or any doctor that prescribed it looked at the privacy and confidentiality information. It is not... I don't know if you'll be able to look it up anymore because I don't know if their website exists anymore, but I don't know that it would give you a lot of, what's the word, faith in their ability to keep it safe. You should all look at this. This is a fascinating website that I found as I was researching it. It's called Blacklight and you can put in any website and it's going to tell you what cookies and what it's looking for. So for example, if you put in pair Reset and Reset-O, there were four ad trackers, there were 15 third-party cookies and the site allowed Google Analytics to follow you across the internet. So that wasn't so, so terrible. I thought it was just really interesting that the core values of 42 CFR is confidentiality and you would be prescribing something that the company is letting Google follow you through the internet. And there's no recourse for it because nobody's really following it. Okay, so privacy concerns. I'm telling you, I will just say this too. I went to this website and I will say the APA, I put the APA in, the APA was really good actually. They're not selling our information to too many places. I want to say Google's following us when I looked at it. I did the same for ASAM. They had tons of people. They were selling their information everywhere. But I started putting in websites I use all the time to see what they were doing with my information. It is eye-opening. It is eye-opening to see where your information is going. And in the midst of that too, there was a, I think it was LexisNexis you could put in and put your name in and they'll send you this information from like Alphabet and Microsoft, what they found on the internet about you, and I got that report. And I can tell you that they sent me back every single place I've ever lived, every misspelling of my name. I mean, there was a huge amount of information that they found just from looking on the internet. So I encourage everybody to try to take a look and see so that you have an idea of where your information's going. Okay. So the next thing that came up was this idea of research. And we know that the, speaking to the choir, right, preaching to the choir is the randomized control trial is the most rigorous method of testing that we have available. So what was out there that there was a problem when you had these prescription digital therapeutics, which are, if you're going to have a placebo, you have to make up some kind of software interface that doesn't actually provide treatment, right? You can't, it's not a sugar pill. You can't do that. So there was this problem, right? It's very hard to construct a app that's giving you CBT, right? You're supposed to be doing CBT through this app that doesn't work. Does that make sense? Right? So it's almost impossible to do. You know, having it look exactly like the one that delivers therapy, but having it not deliver therapy, it kind of doesn't actually work. And when they looked at the digital therapeutics that were using these psychosocial cognitive or behavioral interventions, there was no clear, consistent control condition that anybody was using. It was all over the map and nomenclature was inconsistent. There were not clear descriptions of the controls and it limited the ability to compare across studies and a lot of heterogeneity throughout the literature. The demand, so things remember research, the demand is outpaced the research, particularly when COVID happened. We were doing the research and then COVID happened and everybody thought this, this is solving a problem without thinking about it. I was amazed when I looked at all of the studies for PAIR, for RESET and RESET-O, every single study I came across was either done by the company, PAIR Therapeutics, or was done by someone who was currently or had worked at PAIR Therapeutics, right? So this idea of, you know, bias in those studies might be okay, but when you say it's only one person, it's, you know, they obviously have a stake in wanting the results to come out and that was incredibly frustrating. We need independent studies and we need to be able to do them in a way that replicate the research standards and they have to have the same, we have to be as rigorous as we are for other things and, what was the thought I had about that, hold on, it just ran out of my head. All right. Any questions about that so far? We have a few other concerns. All right. So health equity, it's wonderful to say that we are hopefully trying to do a better job at paying attention to health equity. And I think when we're talking about prescription digital therapeutics, there are advantages. It increases access to care. Somebody who lives somewhere where perhaps a practitioner or a physician doesn't want to live, despite all the wonderful emails we get about, you know, so-and-so place with this amazing salary and only seeing, you know, a hundred patients a day and they don't tell you what city it's in or town or even state sometimes. There are places where people don't live and patients do. So it's really important to be able to access that. It also helps to potentially decrease informational barriers. It might be able to be a way that we can get information from areas where we don't necessarily have practitioners readily available to be able to glean information about what is the population health in this area? What are we finding out about different trends in mental health, mental illness, substance use disorders, the interplay, of course, between medical illnesses and mental health illnesses and how there is clearly an interplay and one thing gets worse when the other is worse. And there's also an opportunity for the patient to begin to have a little bit more self-management, a little more autonomy with their care. So communications with providers also, again, email, right? My EMR offers me secure messaging. So I have a way to contact and connect with my patients in a supposedly more secure way than just, you know, shoot me an email with all your medical information and we'll hope that Google protects it. It's not going to, as we know. So it's very important. We don't want this talk to be something that's it's all bad. This is more, again, hopefully a collaborative and enlightening discussion to say we need more information. We need to figure out what's going on here and it could have some potential major benefits but we need to be mindful of those things because it can also have devastating health care inequities. What if, you know, again, there's places in the country that don't have internet access and they're not a small percentage of the country when you look at the land mass. They might be, when we're talking about the people who live there, they're not necessarily the populations that we see in big cities by far but they're also the populations that might have significant medical and mental health difficulties because, again, they don't have any practitioners there to help or maybe there's, you know, one family med doc who lives there and takes care of the entire city from birth till death. So there's also digital literacy. If you don't know how to use a technology on either end, we talked about the practitioners, the people who maybe not don't have a comfort with computers but there's also patients. We like to think of our patients as, you know, the Gen Zs and whatever the next generation is never looking up from their phone, you know, they don't know even how to type because now they would just hieroglyphs again. But we have an entire group of people who don't necessarily have that digital literacy who still need access to care, who still need care, and many times do live in areas where they might not have reliable internet access or even the ability to access and have a phone, right? So we have these new, you know, we have a lot of different state plans to be able to give indigent populations cell phones. But are they smartphones? Do they give you the access and the ability to utilize this technology? And furthermore, if maybe you left school by fifth grade, do you know how to use these things? Or are you going to be kind of holding this thing going, I don't know what to do with this. There's also a lack of guidance, a lack of area where patients would benefit most and who would be harmed. Another challenge, of course, that exists is with the available health care disparities, anytime we have information on a group, again, one of the things that was being talked about yesterday in that chat AI lecture, which was a really amazing point, was that double-edged sword of the way that, right, chatGBT works is it gleans all of this information from the internet and everything that all of us have left on our servers to be able to be picked up by everything and it gives you a great broad answer. Well, that doesn't necessarily apply. We know that we have information that generalizes to certain populations and is not usable in other populations. So we have that double-edged sword of both finding a great group of information, but at the same time you're also potentially saying, well, in this community we're seeing this data and we're giving this information. Well, unfortunately, there are certain communities, one of them would be the African-American community that's going to look and potentially say, well, why are you treating me different? And we can want to say, well, this is what our information has given us about this particular area and what would be most helpful. And it might be, but at the same time, it doesn't leave a good sense in people's minds because of all of the injustices that have occurred before, all of the mistreatment, all of the health inequities. So we're kind of left with this double-edged sword of how do we give good quality care with this product or any of these products that is both tailored towards the population, but also not discriminatory in any way, not marginalizing in any way, and also not being given, like, you know, when we give the cage to anybody who's not a middle-aged white man, it doesn't apply. So it's not helpful. When this came up, I thought it was really interesting that the message that we were getting from our legislators was like, we need to do everything possible, right, to decrease overdoses. And I had to laugh. I was like, so I can't, I'm fighting to get clean needles. You won't consider an overdose prevention center, right? Things that would actually help, right? So I know that you're using drugs every day, but here, you know, use this technology and do some CBT so that you don't overdose was ridiculous to me, right? And at 1,200 bucks a pop, I thought, wow, is that where we would want our money to go? So if you really want to, you know, and it's probably the bigger issue around overdose versus harm reduction anyway, but looking for easy answers to really complex problems. So this was a great example of like, really? So you really think that widespread use of this for people, right? Who's going to benefit most from something like this? Or the people who are engaged in treatment who would probably benefit from almost anything because they're in a place. How are we getting more people into treatment? How are we keeping them safe until they get there? This, not that it's bad, is not going to do that, right? And how are we educating the population out there that doesn't think that way, right? Because they're looking for an easy answer and we'll talk a little bit about that later. But that's a great example of like, I don't know that you're going to get the outcome that you're looking for in this regardless of what the, you know, the people who are making the product are telling you. So what about prescriber logistics? Well, we don't really have any way to have a curriculum for how to teach prescribers to utilize digital health therapeutics. This is not something I was trained on in residency or fellowship or any time since. We now are having some of these CME lectures pop up, which is great, which is useful. But again, there's still so many questions and when you look at the stakeholders and the people who have invented and created a lot of this information, this technology, they sometimes do have information provided by physicians. But again, let's use the EMR as an example. They sometimes will tout themselves as we were created by a psychiatrist. I've heard of two of them and I'm sure there are more. But they're not necessarily the best ones just because you're a psychiatrist doesn't necessarily mean that you know how to create a platform for an EMR that is user-friendly across all areas of treatment. There's no standardized evidence-based workflow implementation for ongoing research of this product, of any of these products. Uninformed prescribing can complicate our ability to gather reliable data. Again, if you are just giving this out to everybody, which maybe you should, but how do we know? How do we know who's going to benefit most from this and not that we don't need this information, but that's a testing phase. That's not a, right, I would argue that when we have our different testing phases to approve medications and the phase four comes out, where all of this stuff comes in after it was already approved and people say, oh by the way, I got my injection of extended-release naltrexone and I have acne all over, which I had a couple of patients tell me and we had to report to the pharmaceutical company as a phase four and I don't know if this is something that, again, are we ready for a phase four? I don't know. I think we have so many questions still. This to me sounds like where we would have the phase two where we would say, all right, what's the lethal dose? What's the safety dose? And because we have all this lack of concrete information and regulatory guidance and who's going to, what's the deal if HIPAA is violated? Are we responsible because we prescribed it, right? I know that there's commercials out there for so-and-so attorney's office. Did you take risperidone and did you have gynecomastia? Well, we're gonna sue everyone. Okay, so if I prescribed a digital health therapeutic and it turns out that maybe there was a bug in the code, right, and this happens. Anybody have one of those robot vacuums, the Roomba or whatever? So, the month I bought mine, which in January of something, there was an update that came out. I bought it in January and then an update came out and it broke all of the Roombas across the world because it wouldn't work. There was a, someone put a zero in this place where it should have had a one or a one in the place that it should have had a zero. I don't know, but all I know is that it made everybody's robot not work. What happens if there's a code crack with this? How do we protect that? Mike Dawes, VA Boston, Boston Medical Center. I wear several hats in those systems, but I'm the program director for addiction psychiatry fellowship and co-director for the interprofessional fellowship for addiction treatment. So short version is we are aware of everything you're saying and I share those concerns, but I think to change the tone a little bit of what we're talking about here, VA's got a lot of resources and we are developing, we being VA national, several sites are developing digital therapeutic tools similar to Reset-O, but doing it within the system and using it as part of the overall development. So I think we probably would want to have a discussion of the, given the healthcare systems we're working in, how does this apply as opposed to this is potentially dangerous in that, because that that's not going to lead to a solution. So I'm just thinking maybe we should shift the conversation a little bit more to, so what do we do about this? Because it's coming, like you said, but if all we say is there's safety concerns and we don't use it, that's not going to help our patients. It's not going to help our systems of care. Just putting that out there. And the VA has a great digital therapeutic for PTSD, right? And I, A whole lot of it. A whole, right. The VA's doing a great thing and the VA isn't going to make a ton of money from necessarily selling these things, right? And so again, it's just how are we thinking about where it's coming from? And, and I don't, I, we said that from the beginning. I think that my concern was how many people, how, how much are we thinking about this, right? It's happening. And how much are we thinking about the fact that we don't know what would happen, right? If there's no regulatory guidance about whether or not HIP is being violated, right? And you're prescribing something. It's different than just suggesting that someone use it even, right? Or someone's using it on their own. But you're signing your name saying, I am prescribing this for my patient. Is there a difference there? And the hard part is we don't know because no one's talking about it yet, right? And I feel like maybe those are the things that we need to talk about. And I don't disagree. Take our lead like places like the VA who are doing a really good job, I think, with their digital technologies, right? And isn't it funny to say I would just trust the VA more than I trust paratherapeutics because I can't imagine that next week the VA is going to go bankrupt and shut down, right? So lots of different ways to think about it. And we do at the, we will. I'm going to talk a little bit about after this reimbursement. And then we're going to talk about what they have out there to help us decide, right? And ways that we can sort of advocate. I would love, I think it would be great, right? I think that's also what got me here is it would be fabulous if we could just make sure that we're not jumping too quickly without having information. And I think one of the wonderful things about the VA also is they have a population where, first of all, they have a group of patients who have something very much in common. And they also have, at this point, enough other groups where they can tailor something specifically towards PTSD and even further maybe towards MST, right? And they have a group of veterans who might be able to tailor even in the different generations that occur. So there's a lot of positive information that can be gotten. And at the same time, we've seen times where that isn't necessarily generalizable to the world public. And the question in part is, how are we measuring that and how are we creating that? So absolutely, we want to have, and that's the thing, is right now I don't know that we're necessarily coming up with any answers per se. But the idea is to have a lot of questions that we want to be asking. Not saying no, just saying, well, these are the questions. So I'm going to pass this over. We're going to talk about some research. So this is one place where maybe the VA is a little different. And tell me if I'm wrong, right? But are you guys billing for your services at the VA? I don't think so, right? It's sort of... Right. Which is what has come up a lot in, you know, it's been, I've worked at Medicaid now in Delaware for about a year. And I'll preface by saying I heard this when I started, and it's true. If you've seen one state Medicaid plan, you've seen one state Medicaid plan. And so I am not about to say that I'm not even an expert on Delaware Medicaid, much less Medicaid in general. It is an incredibly complex system that has a lot of levers that move. But the bottom line is, is that you're figuring out how to get things paid for. And so this was CMS. So CMS has not come out, despite the FDA approval. They have not issued a national coverage determination, which is a big deal. So when Medicaid, when Medicare comes out, when CMS comes out and says they're going to pay for something, it's sort of like as CMS goes, the private insurances follow. So you're not seeing a whole lot of, the private insurances aren't touching this either, right? It's not just Medicaid and Medicare. And the other thing I want to point out about FDA approval, which I thought was really interesting, when paratherapeutics got their FDA approval, it was 2016. You cannot update your software after that. Because if you update your software, you have to go through the process to have that new iteration FDA approved. So keep that in mind. So when you were using Reset, you were using a 2016 digital platform, right? And that you were going to have to wait and get it approved again to go forward. So you sort of wondered why you would want to get an FDA approval, because even the FDA hasn't kind of caught up with how they're going to keep track of, you know, software that's changing very rapidly. I think about how often my phone updates. I have a new operating system on the phone. Why don't you update it? And they don't have that kind of flexibility with the regulatory process as it is now. But CMS, so billing with CPT codes. So if you bill right now and say I'm going to prescribe a digital therapeutic, right, and you don't have a mechanism to pay, you can pay for your time, but you won't be able to pay for the actual $1,200 that it costs to prescribe it. And then they came up with this level two health care HCPCS code, right, that was for prescription digital therapeutic therapy, FDA cleared per course of treatment. So you could bill for that, but it's a very broad indication. It's not differentiating between which ones you have. It's just sort of like they had to do something, so they threw a code out there, right. So if you, it doesn't take into account, because it's not just reset and reset. Oh, there's several. There's some for insomnia. There's, well, I'm trying to think of the other prescription ones. There's one for anxiety, and they're all a little bit different. So there was no way to kind of know that. And if you don't have individual codes for each PDT, you may not actually cover the cost of what it is, right. It's just we don't have that specific information. And there was very little, there's very little data out there. So interestingly, when we were looking at this, there's an organization for Medicaid that is, that gets called, it's a Medicaid Center for Evidence-Based Decision-Making or something, right, and you pay into it, and they do research for you. And this had come up. And it was very difficult to get any information out of the states that were, in fact, covering it, right, because most of those states had a deal going with the maker, right. Oklahoma and Massachusetts were two of the states that were, Massachusetts came out and said, anybody on MassHealth could get this prescription digital therapeutic without a prior authorization. Your doctor can prescribe it to you, and we're going to pay for it. We couldn't get them to tell us how much were they paying for it and how they were sort of covering it, right, because I think that they were. And then Oklahoma had a whole deal about their value-based care, right, and then they had to have certain measurements, and they wouldn't share what they were measuring to see. Michigan had some studies that came out, very small sample size, that they were like, well, it seemed like it didn't hurt anybody, and it was okay, but the sample size was so small, and it didn't really take into account what it was actually costing. So some of these things have you can be in touch with someone, and they have to get back to you on off hours. How are we paying for that? All of those questions are still out there, and I know that in Delaware there was one organization that was using Reset, and they were using state opioid response grant money for it, right. So the question then became, if there's no more SOAR money, how are you paying for this, right, because Medicaid didn't have a pathway to pay for it. So you want to figure these things out, and we don't know what it's going to cost people, and people get really fussy about getting paid for things. And then this got into reimbursement, so they went bankrupt, right, and they blamed insurers, right. You just didn't share our vision. You wouldn't pay for us, and that's why we went bankrupt. I don't know what to say to that, but they weren't sure that they were going to have any more prescriptions go out, and they weren't sure what they were particularly going to do with the prescriptions that were out there already and what kind of support they were going to be able to give for the folks that were still using it, which I felt was, like, problematic, right. So what are all these patients going to do that were finding this useful? What was the plan? Yes. It was FDA-approved through this de novo classification that they used, yeah. And I think people are using it, like, I saw some of it where they were using it interchangeably, but no, they were like, this is an FDA-approved treatment, which I think is what got the attention of legislators, right, who were saying, why aren't we using it? Yes. To put a little bit more information on the table, I had been talking with them because they were wanting to have us as one of their test sites. Everything that you've said, I parallel basically have added. I'm glad you're here. I was hoping. I was like, please let somebody be in here who's using this. But let me be clear so people are clear what's happening. So PAIR, I was aware, at least the people that were the development part, maybe not the business so much, of some of these concerns. So there were a series of NIH and other funded studies that were under review to address a lot of these issues in terms of at least the feasibility and usefulness at the clinical site operations. The financial part is a separate set of discussions, I think. But they were aware of this, so it wasn't like they were just rolling over and saying, oh, we're not getting paid. They knew this was going to be a problem. They didn't think it would be as big of a problem. But they had anticipated this, and they had done and were trying to do, at least my understanding, a lot of the work to address these issues. But a lot of the questions that they raised themselves and we're raising today, I think there should be some sort of work group within APA to address this because we're going to do this at VA. But outside of VA, I think there's going to need to be what do we need to move the needle forward. And I agree. So I've been working with the state for about six years now, and it's really interesting. So about the first month I was with the state, I met who I now work at Medicaid for her, the Medicaid medical director. And the conversation we had five and a half years ago was, my God, the rates in this state are low for substance abuse providers. They're really low, way lower than the surrounding states. It's why we can't get treatment. We need to fix that. And she got to work, and it took five years. And that was like people were like, wow, good job. You got it done in five years. That was, like, really good. And when you think about the pace of government and the pace of technology, they are very wildly different. And so I think that that's part of the problem. You come along, and even if we wanted to figure out how to pay for it, if we came back and said, we think this is great, we're going to figure out how to pay for this, it wouldn't be like next week we would have a mechanism to pay for it. There's, like, got to go to this state plan, and is it allowed in Medicaid and where's the funding going to come from and there's a million questions and so even if we thought it was good, it could be years before you're set up to pay for it anyway, right? So you feel like it's this tension between how quick the technology is going, which is why we need to have some answers to these questions so that we can move a little bit faster because the legislature is moving fast. So you can see here the, this is what I came up against where they came and said, you know, give us the summary of how you came to decide that you were paying for them and how you're going to do it, right? There wasn't even the thought that maybe we wouldn't pay. I will tell you, I put together the report that DHSS sent back from Medicaid and we heard crickets. Nobody, nobody came back because again, it was very much like, hey, it would be great if this works. Here's the questions that we have, which is why we're not going to pay for it now. We're not going to do the work now to figure out how to pay for it, but we're going to keep watching this to see if at some point it feels like it's something we should do. And we went to, you know, the med group and we're asking for them to research it and we were talking to other states. So it's true that we were doing it. It's happening in Congress. So last year's Congress on 17th, they had in March 22, they had the access to the digital therapeutics act. It died in committee. And then they did one at the very end where I thought they had to know that that wasn't going to happen, but they were giving us a preview. I thought it was great to know that the digital therapeutics alliance of industry, uh, industry leaders and stakeholders is, is lobbying hard at Congress to make sure that they pass this through and, um, sorry, is that, uh, where's the, well, yeah, this is not our 18th Congress. This is the one. So it's showing you that there are two bills right now in, in house and Senate to, um, force Medicare, CMS to start paying for this, right? Like regardless. Um, so we, given that there's the lack of, uh, common standards and all, we have to just make that sure that met legislative mandates don't outpace what we know, right? That was part of what was, we were asking them and I don't know that it's actually going to matter cause I think it's coming. All right. So we'll let Akiva talk about how you can maybe make some informed decisions. Right. And so this, with this, we hope to kind of get into what you're saying about, okay, well, what do we do? How do we answer some of these questions? How do we start to get some of this information? Um, well, AMA has some information on how to figure out if it's a good, uh, system as well as the APA, right? They haven't, they in their, in their web, on their website, they have a way to measure a pyramid of questions that it asks rigorous questions to say, okay, well, does this cover the data safety issue? How does it gather data? How does it keep it safe? And then it flows along in that realm to go with, you know, a series of questions. And if it does this, then the next side of the pyramid is the next step. And, and in that way, it's beneficial in many ways to be able to say, okay, well, we've answered a lot of rigorous questions. Many of them that we've brought up here now that will start to help us to know, is this something, is this an application? Is this a digital health therapeutic that we can get behind? Is this something that seems to be effective? Is it safe? Is it going to give away all of this protected information? And furthermore, what's going to happen if there's a glitch? So there's a lot of pieces that come up because again, these are things that, you know, I'm sure that we can all readily say that just because I had a patient who had a defibrillator pacemaker that was not functioning correctly does not mean that we stop using pacemakers. It means that we found something and we need to be monitoring. And I think the big challenge and the big piece to this is the idea is a wonderful idea. It says there's places where physicians and practitioners don't want to live. There's places where people don't have access to care and there are way more people than there are practitioners. So how do we get more treatment to more people, make it accessible, gather information and help in an informed and useful way? This is why this is important. This is phenomenal information. And I'm reminded back to when we first had this idea under the Obama administration of increasing access to care, you know, making insurance accessible so people could see a practitioner. It was a wonderful piece. It was wonderful. There weren't enough doctors, nurse practitioners, PAs. There weren't enough people to see the patients that now had coverage. And by the way, I was in Boston at the time where, like, you throw a rock and you hit a psychiatrist. So there are a lot of practitioners there. But even there, there still were not enough to be able to treat all of the people that now had coverage. So this is a great opportunity to be able to provide care. So it's not a nay. Let's answer these questions. Let's make sure that we're using these evaluation tools and evaluating the evaluation tools. Once we realize, hey, we have this other question, maybe we need to make sure that this is good. And so we have, again, these algorithms that let us go through a series of questions. So the final takeaways that we've really... I'm sorry. Let me just say one thing to there. So just so you're aware, you asked the question. So there is the APA Council on Quality Care has three committees under it, one of them being the Committee on Mental Health Information Technology, which is where the page that has... You go on to the site and look under the councils, the Committee on Mental Health Care. And I looked up John Torres out of... He's at Brigham, I want to say, or Beth Israel, up in Boston. He's the chair and he does a lot of the research around this. So if you're interested, there is a committee that's working on that. And I'm in the assembly. I had to run back there after this because I'm missing the morning. But there is a way through the APA to bring up these things and ask the APA to take action around some of that kind of stuff, things that we want to know or are concerned about. But we do have a pretty active on the APA components. If you look up at the component directory and put in information technology, that'll come up and you can be in touch with them. And so now, we've kind of gone all over this. And like I said, I think that the important thing that I want you to walk away from this presentation with is we can't bury our heads in the sand. We can't say, oh, I'm not dealing with this. I'm not having anything to do with this. I don't want to learn about it because I don't agree with it or it's new and scary. We can't do that. Nor can we necessarily all be at the forefront of saying, all right, let's embrace this. Let's use it. No questions asked. Just go for it. I think that we really want to take a good, careful look and say, what questions do we have? What do we want to answer? What do we not have an answer to that is a good question? And what is a question that's maybe just, I'm terrified of people injecting a vaccine that might have a microchip in it while I carry my cell phone that tells someone everything about all of us all over the place, including when we're talking about something that the phone's not supposed to be listening. So we can't have this fear idea, but we also have to have a thoughtful embrace. And so with that, I want to open up to questions and more comments about what concerns you have, what experiences you've had. Again, I think it's great that we're going to have an opportunity to get really good information, because I do. I think the VA is a wonderful place to gather information without the threat of financial peace and business in the way, because the VA and half of my residency training was at different VAs in Boston. So I have wonderful things to say about the system. And so I think it's a great opportunity to really gather information. And I think if there's other large healthcare industry areas where maybe the goal is not the financial aspect, which again, is hard to do for anything that's not publicly funded. And even sometimes when it's publicly funded, it's a concern. But when you have a certain group of people that you're able to gather information on and learn how to give a treatment to, absolutely, it's phenomenal. There's a lot of opportunities here. So what questions does anyone have? We want to have lots of time to discuss and come up with maybe some ideas. No? Is anybody part of, other than the VA, is anybody part of a large healthcare system where maybe they're using digital health therapeutics and they're finding information that perhaps will be generalizable? I don't know if you guys are familiar with the behavioral health data platform that was instituted by Colonel Miller Brown worldwide due to a mandate by the Undersecretary of Health. I think his name was Woodmansey. So Colonel Brown developed a digital platform where people would walk in and fill out a questionnaire and it was instituted worldwide. I kind of lost track of it because I left the military a long time ago, but is anybody aware of this? Because it was a sensational project. No, I had no idea and I think that sounds amazing. What's it called again? I'm looking at it. Behavioral health data platform, BHDP. Phenomenally good idea. People would walk in worldwide and they'd fill out a whole series of questions. It was conceived of partly as an information gathering tool and as a standardization tool, but it would help providers as well because they could capture those data in sort of chart form, show people's progress in response to their medications and so forth. It's amazing. It's something you could dream of from a digital technology perspective. I have no idea what happened to it. It's on the U.S. Army website, armymedicine.com. And this is a great example of using digital technology, gathering information, being able to spew it out. I talked to a guy that was trying to get a paper published and it got squashed because he went through using some of these, not prescription, but these apps, and they'll ask you questions and on all of the apps he would say, I want to kill myself, and there was no response to that. You know, sort of asking, what are you going to do if someone has an emergency? These were the sorts of questions that were trying to be asked. And then they've kind of updated some of that stuff and he did not wind up publishing it because they sent a cease and desist letter, the company that had the app that did it. I mean, you know, these are the sorts of things that we want to know that are happening and if there's a database that collects, because it looks here like they're getting all sorts of clinical programs, right, to deliver integrated clinical services across the board, not just digital. Well, this was specifically developed for behavioral health. It's the behavioral health data platform and in fact, I'd be curious to hear if anybody at the VA, I was at the VA for a while, I know people who were familiar with this who were former military docs would kill to get, you know, this instituted and used as a routine tool because it's very useful. But there is, as you can imagine, a lot of bureaucratic intransigence. That's a whole separate workshop, I think, in a way, because I mean, it's, the answer is that there is a transition emerging to databases including all that. So that's the short answer. I think another part to maybe add to this as we move forward, because obviously this is going to be an evolving conversation, is to get to people, I would think specifically of, I'm just putting names out, but the CTN and the New England node and the Columbia node, they've got data using digital therapeutics in there. So I think it's, and that's a NIDA funded thing, and I think ongoing work, I think would be good. They actually are soliciting questions as they move forward because, you know, they're aware of the situations, but their data is in process and going to be published in the not too distant future, I think. So getting that conversation going, too, is going to help move this forward. Absolutely. Anyone else have any experience or any questions that, or perhaps any answers to the questions that we posed? We'd love to hear answers if anyone has that. Hi. My name is Richard Baer. I originally trained as a psychiatrist, but for the last 30 years, I've been a medical director for the Medicare program. So when you showed that slide that they wanted to put in a bill to cover this, have CMS coverage, I think this would be very helpful for you all because what's going to happen is, so CMS has to institute some sort of program for coverage, but they still have to grapple with 1862A1A that says it has to be reasonable and necessary for the diagnosis and treatment. And a lot of the contractors, which is where these coverage decisions go to, haven't wanted to cover this and mostly have not. One is they don't want to deal with it because there's just too many of them, but secondly is they would have to grade them upon the same standard of evidence that they do every other medical device and drug. And that standard of evidence is pretty high, and most of these things don't meet it. So they just say, not reasonable and necessary, you're out of here. But if there was some sort of mandate that they had to take up the coverage, it would probably go back down to the contractors. If CMS were to do it, it would take forever. But if they go down to the contractors, they would probably put in a policy much like the slide that you had that showed all of those criteria that they would have to meet. And if Medicare set that standard, then everybody would fall in line. So that could be actually a good thing. And one of the things that I'm thinking about when you're talking about this is, a great example would be ECT, right? It was FDA approved before you had to kind of know how things happen and worked, and we know that it works. We know that it's an effective treatment, but it would never have passed any FDA studies today. And similarly, we are finding difficulties. And I think some of these are the challenges of where do we build barriers and where should we not build barriers when we're looking at effective treatments? I mean, think about how many billions of dollars and how many years and how many studies it took to be able to say, you know, housing is important for people's well-being, right? We have the Housing First initiatives. And I feel like that makes sense. Anybody who's not undomiciled knows that they feel comfortable going back to their home. So there's things that are potential here where there's really great opportunities. And we just have some baseline questions, I think, that at least are reasonable to want to answer first. Data safety being one of them, as well as maybe, and I think COVID has taught us a number of things, one of which is, do we need to be as careful? Is HIPAA out of date, right? Why is it that I can talk to somebody on my phone, and it doesn't have to be HIPAA compliant, but if I can look at them and talk to them, all of a sudden, the dangers are ever-present? I think that we not only, what these new technologies are showing us, and some of them, the old technologies are showing us, that we really need to figure out what are the standards, and then we need to be able to establish, are these standards appropriate for the application that we're looking to use them for? You gave me something to think about, because I really like the idea of using the legislation to force CMS's hand into actually looking at it, where that also then comes into us being able to advocate as the APA and a psychiatrist, to make sure that those are the things that they're looking at when they are making this decision, knowing that even if it gets legislated, it's going to be a long time before we get there at the pace. That's a good, that's a, I'm going to keep thinking about that. The other thing I thought was funny is that PACE wanted, or PAIR wanted $1,300. There have been a couple of just simply electronic things that CMS has paid for, and it's usually a dollar and a half to three dollars, and they expect it to scale up. Exactly. I think also, and I'm not representing any of my institutions per se, but my own personal thought is HIPAA itself is going to need to evolve with these technologies in terms of what's real, because when it was written, these technologies did not exist, and they're going to evolve. It's the same thing as the regulatory for FDA, that it's going to have to have a more nimble way of re-avowing this in close to real time. I don't know what that's going to look like, but I've been thinking about that part as well. Well, and I'm thinking about, I always think 42 CFR, too, the extra protection for substance use has actually become, in many cases, a barrier to providing treatment. This may be one of them, right, but there's these pieces that we need to kind of think about if the government's going to move, because we want to advocate and make sure they're doing it right. Right, and I think that the other thing that would be helpful is to have these different technologies where, and obviously this goes against the capitalistic nature of it, but maybe it needs to be open access. It can't be proprietary, because EMRs, when they first came out, everybody remember hearing, oh, you'll be able to read everybody's notes on everything? And unless you're at the VA, which is a phenomenal, again, that was my favorite EMR ever, despite its lack of pretty aspect, you could see what someone said about someone across the country in a note. You could know anything. You could know when the last time that guy had a cold, right? It was so helpful, but unfortunately now, I mean, I have patients who come to me, and I'm sure you all do too, where they're like, well, don't you see my records from so-and-so hospital when I was hospitalized in 1972 from, you know, no, no, I can't see that, and even if it was, you know, 2022, I can't see that, because their system doesn't talk to mine. Yeah, they can read my note now, because I typed it instead of, you know, my chicken scratch, but, which is great. Already, that's a win, but at the same time, they can't, I can't access this information. Well, and then it gets you thinking about health exchange, health information exchanges in the states, right, and how we sort of Frankenstein things together to try to get information out there, and it gets really convoluted and difficult. So how do you sort of think about these things from the start, and it'd be nice if we could do that with, get involved in it with this, because it's coming, and you're right, CMS is going to have to do something soon. Any other thoughts or questions? Great, thanks, everybody. Well, thank you so much, everyone. Thanks for coming. Thanks for having me.

digital health technologies

digital medicine

digital therapeutics

privacy concerns

medical practice

generational gaps

electronic health records

telehealth

wearable tech

data privacy

reimbursement issues

regulatory approval