Interoperability Final Rule with Don Rucker, MD from ONC
Episode 19311th March 2020 • This Week Health: Conference • This Week Health
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 Welcome to this week, health events where we amplify great thinking with interviews from the floor. The floor happens to be in my home office this week, but the interviews are going to go on Special thanks for our channel sponsors. . Starbridge Advisors, health lyrics, Galen Healthcare, VMware, and Pro Talent Advisors for choosing to invest in our show and the next generation of health IT leaders.

My name is Bill Russell Healthcare, CIO, coach and creator of this week in Health. It a set of podcasts, videos, and collaboration events dedicated to that purpose of developing the next generation of health leaders. Uh, we're going to go on the record that today, right now with Dr. Don Rucker, the national Coordinator for Health It for the ONC.

Appreciate him coming on the show. A lot going on right now. We, we cover all things 21st Century Cures Act, as well as the, uh, uh, the final rule, which just came down on interoperability. So hope you enjoy Dr. Don Rucker, national Coordinator for Health it for the ONC. Thank you very much for joining us. Uh, really appreciate it.

No, it's, uh, always great talking with Bill. Well, I appreciate it. The, uh, you know, the, uh, the proposed funnel rule coming out this week. This is a, you know, from where I sit, having been in healthcare and you as well for, for many years, and seeing all the challenges since we, I. We rolled out the EHRs and, uh, the interoperability and all the challenges people have had still getting their medical record, the innovators trying to tap into the medical record and, uh, provide value.

Uh, this appears to me to be a pretty seismic event within healthcare and healthcare. It, uh, is that how you guys are viewing this? Yes. Um, I think, I think that is a, um, a fair statement. So. Challenge has. Historically it has been largely technical, right? So historically, you know, I started in the day of, you know, serial ports on computers and most of your audience probably doesn't even know what that is, and parallel report ports on computers, and most of your audience probably doesn't know what that is.

Um, but over the last, um, 35 years, really 40 years, um, we've gotten a lot better. And so. If you look, um, compared to, uh, let's say in the eighties, um, you know, in the eighties we had the computer science, you know, the algorithms we had, but we didn't have the compute power. We didn't have the data really to compute on, and we certainly didn't have the networks to share that data or make it interoperable.

So applications were really. Almost by definition, standalone activities. You know, in the nineties you started seeing some of the client server, um, type of approaches, but today we have, for the most part and most of the country, um, widespread broadband. And of course with the, um, EHR now being. Almost totally electronic.

We have the data and we, and we have the compute power. So now I think what's been missing is a little bit of the will and the business case really as much as anything else, right? Because obviously the rules, um, are more geared to addressing behaviors. Rather than inventing new technology. And the, the challenge has been from a behavioral point of view that, um, in this third party world over the, with lots of crest subsidization over the, all the decades, we have, um, created incentives that are very much, um, I won't say they're anti-consumer, but they really ignore the consumer.

Right. We don't have, as consumers the kind of choice that we have in the rest of our commercial lives because everything in healthcare has been abrogated to various third party decisions. So the payers, providers, the government, um, as opposed to having a one-to-one between the patients and providers with maybe.

The insurers as catastrophic insurance. Um, and, you know, questions of equity done through a similar kind of mechanism we have made, um, almost first dollar. I know people have deductibles and copays, but from an economics point of view, we have made almost first dollar go through the hands of third parties, right?

Um, one way or the other, whether it's calculation or deductible, obviously that world. The incentives that we have created and that people respond to have led to very consolidated delivery systems. Right. The big, the, the basic how to be CA successful CEO in healthcare. Is really a, um, buy as many hospitals, merge as much of the business as you can to be a price setter to payers.

Well, in that kind of a world, your concern is not interoperability and a seamless consumer experience. It is having. To prevent leakage. So all of a sudden now, um, the, the business case for sharing has to really come from the public sector. It really has to come from rulemaking, you know, from patients, from employers to say, wait a minute, we are left out of this game and this equation, and we want to have smooth functioning access to our data.

So we want data. In public ways that we can access. Um, and that's, um, that has been the component that has really been missing. Um, and that's the component that the Cures Act and our rule put into place. Yeah. So the, uh, that, that is a good foundation for the y I'd like to walk through a handful of things.

So the, the, uh, interoperability technology, the business models. The protection of inter intellectual property, which is one of the things that this really helps with, uh, the data. Uh, so talk a little bit, we're gonna talk a little bit about U-S-C-D-I and the foundation for that. Uh, and then the behaviors, we'll come back to the behaviors 'cause we still have to Sure.

We fundamentally have to address those things. Uh, the interop, I have found this as the more I keep looking at this, this is. This is not thrown together. This is very well thought out over many years. I mean, 20, I mean, this is, this has been in the works for a while. So the, the technology is based on APIs, based on fire, uh, I guess, uh, uh, version four of.

The, uh, their, uh, certification bo the HL seven certification body is gonna maintain those APIs. So we're gonna have a, a fundamental framework that most developers understand most, uh, EHR providers understand in a way to connect these things. So, uh, talk a little bit about the inter interoperability technology and then, and then we'll move on to some of the other things.

Yeah. Looking at the technology stack. Um, you know, that has really evolved in part and parcel over the years. I think the, um, probably the biggest advance, you know, the two biggest advances, I would say in the technology and the really software, right? Because we're using TCP IP in the internet, um, and all of that provision.

But, um, one is, um, the. Um, restful the concept of a restful API. So restful is a combination of an acronym and a modifier. So the acronym is the capital letters, REST, and then the modifier CFUL. So REST is stands for representational state Transfer. And what that really says is simply, rather than sending over the data with, um.

Intermixed with instructions. It really says send the data over as just a pile of data, a much simpler thing to do. And then, um, you know, the instructions can be done on site. Uh, that has combined with a very plain texty representation of data called JSO, which is, um, even more elegant than XML, I mean, XML was a.

Pretty profound standard and let lots of things happen. You know, the angle brackets that we're used to, but the, the JavaScript object notation, the JSON. And then there's a gentleman named Graham Grave from Australia who, um, started putting that into a format for healthcare, um, called fire, which stands for fast healthcare interoperability resources.

And as one might imagine. Is the C for many puns of which, uh, ONC has been guilty of several as well. Um, but that combination of things is a powerful, is what drives most of the internet. So developers who aren't steeped in some of the prior healthcare specific technologies. Um, so HL seven, version 2.5 was maybe the classic interop, um, uh, you know, software.

Um, protocol for content. Um, HL seven now is, is sponsoring fire. So I think we're making that transition and it has the practical matter of letting a lot more people play in the healthcare game based on their skills and open source tools. , right? So we're not talking about, um, you know, things that almost get to the black parts of programming that are, you know, very unique to healthcare skills we're talking about, you know, um, things where a lot of folks can, um, you know, be contributors.

Yeah. And provide options to the public. Yeah, and I was looking at this and it's, it's not just for the consumer, although the consumer's a big part of this. There's, there's, uh, you now support, uh, uh, fire and bulk, or bulk and fire. I'm not even sure what the acronym is, but it's gonna give me the ability to, to, to move population health data around and, and be able to move, uh, uh, clinically integrated network data around which we always struggled with.

'cause our clinically integrated network, we didn't control the EHR, so we had. Many, if we were able to bring that data together, we we could be able to look at the quality measures across that entire network. Yeah. Which was amazingly difficult prior to this. So there, there are mechanisms within this, not only for the consumer, but also as a foundational layer for interoperability between health systems, between providers and, and others.

m, so when I got into this in:

Um, it became clear to me that when we talked about fire and queries, there was something truly funny going on, which was that these queries only returned an N of one. They were designed to return a single record. Um, somebody who's formerly studied database science is like what? Um, the query only returns one record.

Um, I mean this was unfathomably primitive to, um, and so in talking with Ken, um, who had had, um, led the work on the Argonaut standard that made the initial, you know, query of one, um, right. You know, getting the patient's record to communicate with an app, that all made perfect sense. We talked about what it would take to simply extend it, right?

It's not a huge. To extend this, given you've already represented the data in fire, right? The, the heavy, heavy lifting is already done. So this is a, the, the simple part of the iteration, arguably. Um, at the same time, the, um, and, and we heard the same things Bill that you just described. We heard that payers who are, you know,

Our agents in buying healthcare can't actually get at electronic medical records any practical way to see what they're buying on our behalf. Right. Uh, so they, uh, you know, either you have to do bespoke one-off queries. I know that's redundant. Um, or you have to do, um, you know, you have to. You know, paper records or you have to pay.

Um, we've heard reports that major payers had to pay EMR vendors $5 a pop to get the electronic medical record. Um. That they already had a legal title to because they were the payer and, and you know, payers get to see the medical record. Um, all of that is a very, um, horrible way to buy healthcare. So we came up with, um, initially when I was talking with Ken.

Um, you know, just, I called it, well, you know, bulk fire so that it's not an acronym. It was just a conversation I had with Ken. It always seemed a little in harmonious. Um, we'd heard some suggestions to call it population level data. I tried doing that, but um, shorter words went out over longer words. So. Um, I think we're coalescing on bulk fire.

Um, though, um, if I, you know, realized it was gonna have legs, I probably would've thought about it and done it, named it something a little bit, uh, um, more tasteful. But the point of it is, as you point out, profound. So what Bulk fire allows is, um, that providers on their own, which often they've not been able to do, have.

Ability to get data out of their systems and use that for their purposes. Big data analytics, it means that providers, I mean payers will be able to actually measure performance of providers. Um, and, you know, contract accordingly today, if you're a payer in the us, you, um, to decide who's in network. Um, you know, the only real decision points are, are fundamentally three.

Um, you know, one is, are they so big that you have to have them in your network? 'cause you know, they've consolidated that you don't have a choice effectively if you wanna be in business. The second is, um, will they give you, you know, a great price? Um, or a better price, or, you know, some price you can live with.

And then the third is, is this somebody you want for reputational reasons, you know, their world's famous notice. In that list of three things, nowhere was there any actual discussion of bonafide measurable quality, right? Can you imagine in our consumer lives if we bought stuff without figuring out whether it was any good?

ow, starting with a rec circa:

They're on very small sets of data. They're, um, it's heavily lobbied. They're, you know, lobbied to be. You know, set the bar about a half inch above the ground on the provider side. Um, they really don't add much, but at the moment, they're the only show in town here. I. In a big data world, if a payer has access to all the data, it is easy to use any machine learning algorithm and separate providers to whatever granularity of quality you want, whether that's quartiles, quintiles, deciles, whatever granularity you want, and it'll be way more reproducible than the current, almost random measurement of quality.

So I think you absolutely hit on. If we have the APIs to make this doable as opposed to a, um, a swamp of excuses, we're going to, um, have a lot more potential accountability. Um, and you know, that accountability of course, is not just on providers, but it actually, there's mirror symmetry that payers will have to actually figure out what they're doing to add value.

It's very profound. Um, you know, it's, um. It, it, it, I think is important. It's modern. Um, and it's, I think what Congress was looking for when they said application programming interfaces without special effort. Yeah. So when we, so one of the things, the next thing that people are gonna talk about is the data, right?

Because we Mm-Hmm, , you've seen the EHR data. I've seen the EHR data and, uh, it's, it's kind of sloppy. So U-S-C-D-I steps in. Defines the data classes, defines the data elements, and, uh, gives a mechanism for future data sets and data elements as well. Right. Um, give us an idea of what's in, uh, what people can expect upfront from this, obviously within the 36 6 month timeframe or, or the implementation period.

Yeah, I think it's, we ended up on 36 months. Right. Well, it's, it's, um, it's, it's, it's a bit nuanced. So the information blocking for the first two years, starting from month six, um, to month 24, uh, the information that needs to be released is us coordinated for interoperability. So, um, there's, um. Allowance for different formats for releasing that, um, what's called a content and manner exception.

Um, so what is the content you have to release and then what is the manner you have to release it in and the, um, APIs, the US core data for interoperability, the, that, that API kicks in 24 months after the rule posts and then the, the broader data formats kick in at 36 months. Great. So the clinical data, so the clinical data that's gonna go across, is that the typical Pam e data, the problems, allergies, meds?

Yep. Immunizations, uh uh, um, yeah. So the things that have been added there from the Common Core dataset we've already had in our certification program are clinical notes and some provenance data and some, um, better demographics for patient matching. What, what do we have? So one of the big. Exciting things from where I said, is the insurance data actually flowing back and forth as well?

Um, so not only is it the, uh, insurance carriers can take a look at what the providers are doing, but the providers can now integrate in terms of research and other things. Some of the, some of the insurance data. Yeah. Um, but what, what insurance data? Have we defined any insurance data that's gonna be moving yet, or is that in the future?

Yeah, I think, um, there, there's some early work at CMS with the, um, the blue button work, um, you know, for the CMS data. Um, but I think a lot of that is still a work in progress. Um, the intent is to use as much, uh, well to use fire to do that, but, you know, there's still work to be done there. Yeah. And, and no revenue cycle data yet that, that will come at a, at a future date, I would assume.

Yeah. Yeah, well, so the CMS rule, and we should really ask CMS about their role. I'm, you know, a little bit out of, um, out of the bureaucrat bureaucratic swim lane if it wa if, if you will, in talking about other agencies rules. But, um, obviously there will be claims data there. So there'll be a version of revenue cycle data.

Um, I think. The, the concept there is in fact that that serves as a quality measure, um, because ideally the clinical data and the revenue cycle data should sort of match up right when you get right down to it. Um, I wouldn't wait for that to, you know, year one of the rule, but over time, um, it wouldn't, it's not hard to imagine the writing software to make sure that they match up and are in sync.

So let's, uh, you know, in our, in our time here, I, I wanna, I wanna hit on practices, you know, so some of the things we've seen over the years is, um, EHR contracts, just contracts in general that house this data. They have certain das confidentiality agreements, uh, hold, harmless, just whole bunch of stuff in them that essentially.

Uh, you know, it, that is the antithesis of it doesn't allow us to share the data and it doesn't allow us to get, uh, a, a clean view of the data. So we now have to address behaviors we put the technology foundation in. But as we know in healthcare, the behaviors don't naturally follow 'cause there's no financial incentives in a lot of cases.

Follow. So you, you really do have to put a, a, a, a stick in place. So there are, there are, and I've heard, I've heard, I, I've interviewed, um. I've interviewed, uh, uh, entrepreneurs who refuse to go on the record because they don't want to, they don't want to get on the wrong side of EHR providers, but they say, Hey, if I go into their, their app store, which is, you know, Hey, we have an app store, we're interoperable.

They have to pay to access the data, they have to pay a fee for something else. And they have to essentially give away their, their intellectual property in order to participate in the. In the app store. So this addresses a bunch of that as well to sort of level the playing field. Yes. So, um, well we've heard multiple complaints about those behaviors as well.

The, um, so for the US coordinate, so first of all, our rule, the rule that we've just released, um, is for write only. Rather than read, write into the EHR, that's a whole separate conversation. Um, and the way we've, you know, there's a act. Um, accessing data, protecting the IP of the EHR vendors. Um, I think there are a couple sort of conceptual points that, um, that provide, um, you know, provide signposts here.

Uh, so first of all, the biggest one is other than an individual right, of access all, any other data access. Is covered by hipaa. These are HIPAA covered entity business transactions, so all the big data. Any use of the bulk API would be a HIPAA contracted transaction between a covered entity and a business associate or within the covered entity.

So that has to be clear 'cause I think sometimes. Um, some of the people who don't wanna share data sort of get very sloppy and claim, oh, all this data can be downloaded. That is in fact, um, just simply untrue. Um, so, but that's, that's said by a lot of people because, um, you know, they, they'd like to say it.

Um, the, uh.

We've put, we've heard a number of complaints on API pricing schemes that have the effect of interfering with the access exchange and use of electronic health information, which is what's required under the CURES Act. So in order to address that, um, and you could argue of course, that any fee interferes with that, right?

I mean. By definition by, but in order to balance the fact that any fee interferes with this, but you need, um, revenue streams to have these APIs we've come up with, um, for, for these core APIs. Um, for example, the API that a provider would need to buy from an EHR vendor to be able to give data to patients for free, right?

So that's not. It's not free. It's embedded in the cost of healthcare. It's a cost of doing business just the same way I have to buy a medical license. You know, turns out that's not tax deductible, whatever. There's lots of costs of doing lots of costs of doing business. That is a, a cost of doing business in a, you know, regulated world.

The, so those APIs that support that access, um, and those, that class of APIs have to be, um, you know, co costs reasonably incurred, um, you know, with reasonable profit that we've defined, um, which you can read in the rule, but amongst other things. It does not include, um, give me all of your ip. Um, and it does, and it has to be done on a, um.

Non-biased fashion so that you can't say to some app vendors okay with you. We'll do business, but you know, some other app vendors, um, you know, we might wanna be in this space in two years. So we're gonna take your ideas, build out our own product, and not let you hook up. So it has to be on a non-discrimination.

The licensing has to be on a non-discriminatory basis. That's that part of it. Now, if there are value add, if there are other business services, um, those things, you know, that go beyond the U-S-C-D-I, um, those, um, are whatever the market rates will bear, uh, our assumption is. That over time, the, just the transparency and the visibility and um, into how to use these APIs and what their costs are and just customer demand of EHR vendors will sort of bring this into something that's reasonable.

Um, even for the ones that are not protected under the CURES Act. Yeah, and this is 21st Century Cures Act is, uh, is interesting to me in that it really does. We, we talked about this the last time you were on the show. We talked about creating a market and now we've, we've essentially created a market for cures.

We've created a market for experience. We've created a market for, uh, for quality and accountability within healthcare because we've opened up the data, which is . The first step is the necessary step. Yeah. Yeah. So, so what do you envision, uh, what, gimme some ideas of the things you envision are gonna come out of this as a result of this moving forward.

Yeah. You know, I think it's gonna be a sequence of things, right? I mean, these things take a bit of time to learn. So I think as you look at the tranches of products that might come out, I think the initial ones will be, um, and there are already a number of them out there now, um, you know, from large companies like Apple to smaller companies, like, uh, my patient links, um, health number, um, you know, you're gonna see initially.

Versions of the electronic medical record, I think you're gonna see explanations of what's there, what the tests were, what um, what the services were, maybe interpreting the record. Over time, I think you'll see things that re-engineer care, I mean, right now, um, you know, chronic hair, very episodic. But as we can instrument more of our bodies with all of this amazing technology.

You know, we'll be able to tighten the feedback loop between treatment, um, you know, diagnosis via the smartphone and treatment, where some of these, you know, even if that's just pills, because we'll have tightened that loop a lot more. So rather than visiting your doctor or getting a blood test every. So often, let's say there were tests that could hook up to the smartphone or glucometers, which is the case today, or peak flow meters or heart rate monitors.

The Apple Watch would be a perfect example. All of a sudden we're tightening up all of that. I think you're gonna see an incredible mix of things. I. Um, you're gonna see not just from the president's executive order, um, and the, uh, rulemaking that the administration is doing on price, but I think even just for market forces, you're gonna see all of these things wrapped up with price as people can start shopping, right?

Because if you don't post your prices and it's otherwise shoppable, people are gonna go to where the lowest prices. That is America. We know that You can ask Jeff Bezos if you have any doubt on how that might work. I think he can probably explain it to you. So, um, so I think there's going to be a lot of transformation if you think about the internet of things, which I'm sure some of your audience has thought about in terms of healthcare.

Um, right. The smartphone is essentially our computer network in our homes on some level, right? So if you get the medical data, the smartphone, and then anything else you hook up to the smartphone, you create a much broader environment than just, it's an app. Yeah. So that's, that's my sort of belief of what's gonna play out here.

So last question, and I appreciate you giving us a couple extra minutes here. The, um, you know, there's gonna be laggards who step back and they say, well, you know, we'll see what happens in the election. This will change, just like other things will change if this administration gets moved out. But as we've talked before, this is the 21st Century Cures is bipartisan.

And a lot of the, the work that's going on at OMC and HHS is just a continuation of work over decades. I mean, it's really been kind of consistent of moving in this direction. So there isn't, the laggard doesn't get to sit back and say, this isn't moving forward. This is, this is pretty solid. What would you say to those guys?

Yeah, look, the American public is unhappy, would be an understatement with American healthcare. It screams out for transparency. Um, it will happen one way or the other no matter what. The party is the the Cures Act rule. It's quite bipartisan. The Pures Act itself was voted almost unanimously. Um, the work on information blocking was done in the prior administration.

Um, the, the law writing was done, you know, with, um, with the work of prior administration and both parties. Um, as I think folks are quite aware, the president, um. Is extremely interested in having Americans being able to shop and control their healthcare. This is a center point of all of the executive orders of all of the policy making, as well as creating markets and things like drugs, um, to, you know, have things to shop for.

Um, and frankly, um, I believe that will, you know, that search for CONT transparency is global. It is part of the age we live in. Maybe there's too much transparency sometimes and you know, in social media, but it is a global phenomena and I think people have to. Providers, payers, you know, economic parties here are going to have to, if they're working as most folks are on somewhat or highly non-transparent business models, they're gonna have to really start thinking about what does my world look like?

es and arguably going back to:

e lifetime. If you go back to:

Um, it'll allow real wage growth. Um, obviously for those of us who are in the healthcare space, I think we're going to, um, have to rethink some of our, um, embedded assumptions. Yeah, and, and with this show, I'll post a bunch of links underneath. I think a lot of health systems are gonna start doing their gap analysis, like, well, they should have started six months ago because the writing was on the, well, if I can say, you know, if I can say one thing there, you know, we have tried to make this rule from a provider point of view and even from a developer point of view, be.

Actually a very straightforward thing. I mean, if you think about, I know there's a lot of back and forth about all kinds of things, but ultimately what is required here, what is required here is a database driver on whatever format you have is a database hooked up to a server endpoint, um, if you will, um, you know, which obviously the EHR providers will presumably.

Um, provide though others could arguably provide it. Um, and so you as a provider, obviously have to maintain that endpoint and the IP address on the internet. Um, but you're basically hooking up a server, um, to the internet in terms of costs. Um, something that I think is quite doable from a, you know, hassle point of view.

This is not one of these things where we're touching a thousand pieces of the system. You know, frankly, like some of the things in meaningful use were, um, where, you know, all kinds of behaviors have to change. Behaviors will change here, but they'll change because of market economics. Yeah, it is. It's a fire server.

It's, it's a rest API. So it's . Yeah. They're not gonna change. They're not gonna change because of, you know, the rule says you have to change your behavior. It's, you'll wanna change because, you know, there's that accountability. Well, and I also think, well anyway, we, we could keep going. I, I think there's a lot of benefits internally for an HI health.

It. Organization. I think once they get past the initial shock, they're gonna see, uh, great benefits, all kinds of opportunities, all kinds of opportunities to rethink what they're doing, get smarter, better at it, actually control their own data. It's, it's. Um, it, it's really the modern way to go. I mean, in healthcare we've been the only sector of the economy that hasn't done this kind of stuff.

Everybody else does this. Um, I dare you. The name in industry, um, you know, a major industry in the US where these kind of analytics and approaches. Aren't part of, um, you know, common work. So it's gonna be exciting. It's, it's going to be good. It's gonna be good for the public. I think, uh, you know, providers who are, uh, are uh, offering valuable services will be well rewarded.

Yeah. And if, if you were ACEO right now, you would be pulling your strategy people in and saying, look, we just got this thing just opened up. In the next couple of years, we're gonna be able to provide a whole new set of services. So yeah, let's start, start brainstorming. Absolutely. What? What can we do? And, yeah.

Yeah. Well, Don, thanks always, uh, great show. I really appreciate your time. All right. Um, I'll post a bunch of links so you don't have to go through all the, all the proposed rules stuff. All people can hit the episode and go from there, so thanks, thanks for your time. I really appreciate it. All right, bell.

Great. Great. As always, great talking. You take care. Bye-Bye. Yeah. Special thanks to Don Rucker and the team at uh, ONC for making him available for the show. Really appreciate it. And, uh, I, as I said, I'm gonna, I'm gonna put links on the page itself. . So if you're listening to this in your car and whatever, when you get to the get to the office, hit the page link and it'll have a bunch of links to the uh, ONC proposed rule, what's different from the proposed and the final rule, and a bunch of other things like that.

Uh, awesome. So, uh, don't forget to check back a couple times this week. We're gonna be recording a bunch of shows. I have two more recordings going on later this afternoon. It's Tuesday afternoon of HIMSS Week. Uh, tomorrow I think I have three or four more interviews already scheduled and, uh, that may not be all.

Uh, so this week that's what we're gonna do. Next week we go back to our normal schedule. We'll have Tuesday Newsday, and then on Friday we'll do, uh, industry influencer, uh, conversation. So this show is a production of this week in Health It. For more great content, you check out the website this week, health.com or the YouTube channel as well.

Thanks for listening. That's all for now.

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