October 20, 2022
Episode 16: Meet the Medical Consumer with Alan Foreman of B-Secur
Medical hardware companies are adopting consumer approaches to data sharing and visualization. Consumer product companies are implementing medical-grade technology. Are these two industries headed for a collision or a convergence? And who exactly is the “medical consumer” that will benefit from this convergence? Alan Foreman, CEO of B-Secur, joins Justin to talk about the value of wearables in preventive care, who medical-grade wearables are really for, and what it will take to deliver truly accessible, actionable medical diagnostics at home.
Justin and Alan explore some common concerns arising from this rapid convergence: Who’s ultimately accountable for acting on the data that wearables generate? Where’s the line between wellness monitoring and invasive surveillance? And can consumer companies stick the landing as they transition into healthcare?
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Justin Steinman (00:00):
Definitively Speaking is a Definitive Healthcare podcast series recorded and produced in Framingham, Massachusetts. To learn more about healthcare commercial intelligence, please visit us at definitivehc.com.
Hello and welcome to the latest episode of Definitively Speaking, the podcast where we have data driven conversations on the current state of healthcare. I'm Justin Steinman, chief marketing Officer at Definitive Healthcare and you're host for this podcast.
We've got an interesting episode lined up for you today. If you look around your office, the subway or the coffee shop where you're like listening to this podcast, odds are that the majority of people around you wearing a health device on their wrist, Apple watches, Fitbits, Whoop bracelets. It seems like we're all obsessed attracting our health through these devices. I'll admit, I'm an Apple watch wearer and I use it to tract my runs. My wife might call it more of a walk every time that I exercise. And while I'm exercising, I'm always monitoring my pulse to ensure that I'm in the optimal zone. What that is, I'm not quite sure, but my Apple watch says it's optimal, and I've always wondered how exactly that watch can figure it out. Well, today's guest is going to answer that question for us and so much more. I'm joined today by Allen Foreman, CEO of B-Secur, a global leader in EKG technology. Headquartered in Belfast, Ireland, B-Secur develops a technology that powers everything from these smart watches to the powerful EKG machines that you see in the hospitals. Alan, welcome to Definitively. Speaking.
Alan Foreman (01:37):
Thank you Justin. It's a pleasure to be here.
Justin Steinman (01:39):
We are so happy to have you. So Alan, to get things rolling here, can you share a little bit more about the products that B-Secur builds, how they work, what this whole EKG thing is? I'm pretty sure I didn't do justice in my introduction.
Alan Foreman (01:51):
Yeah, Justin, I think you did pretty well.
Justin Steinman (01:54):
Alan Foreman (01:54):
You're right that a lot of people out there have consumer devices, smart watches and the likes, and you're absolutely right to notice that there's an awful lot more features related to health coming into those devices. There's an immense amount of investment from large consumer tech companies going into health features, into smart watches, and rightly so, we're all demanding more. We, in a post COVID world, are looking to control and monitor our own health situation wherever we can. Even if you wanted to go into a hospital for monitoring, maybe you can't get into a hospital or the facilities don't exist. We're touching right at the heart, excuse the pun, of what we are dealing with, which is the consumer tech market and the medical device market of old, the stalwarts of companies who are delivering technology, very, very high accuracy in medical settings versus consumer tech companies who are producing great tech for you and I, every day customers. And somehow those two things need to come together to work out to become true medical diagnostics.
Justin Steinman (03:13):
So you really think this is a medical diagnostic, right? Do you have to be certified to be a medical diagnostic or approved or something?
Alan Foreman (03:20):
Yeah. Let me give you an example. There's some manufacturers of consumer tech out there who have atrial fibrillation detection, arrhythmia detection on their devices. To make that real for diagnostic purposes, where it really bodes the attention of a medical practitioner, you need certification on that device and FDA clearance for some markets for that device. And that is clearance for the piece of hardware, the software, the data that's within it, that it all works to a certain standard and can be relied upon for diagnostic purposes.
And that's where the consumer tech company is really, really trying hard right now. This again, is not something consumer tech companies have done much of in the past versus the medical device companies who've been doing this forever. The only difference being consumer device companies market to the masses, medical device companies market to the very, very small number of patients that they are able to treat.
Let me coin a bit of a phrase for you. Those patients who use medical devices in the past have been called just that, they've been called patients. Customers of consumer tech companies have been called customers. I think we're moving to a world where there's a medical consumer out there, where there are everyday people in their home environments that want the same medical grid technology that has only been afforded in the past in the hospital. Bringing hospital into the home, another phrase that we coin.
Justin Steinman (05:07):
Hospital into the home. You're hearing that all over the place right now. Companies like CVS are buying signify health of like $8 billion or some crazy number to get into the home and to deliver healthcare, and there's no question that we're getting there. But I guess my question for you is, who is this medical consumer? I'm going to knock on wood and say I'm pretty healthy. I don't think I'm the medical consumer. I just want to know how many steps I'm getting in every day. Who is the medical consumer?
Alan Foreman (05:34):
Great question, Justin. A number of years ago, not so long ago, you wouldn't even have been considered how many steps you're getting in a day, but you are now. And said company, a lot of people suggest it was Fitbit who came up with that concept of counting steps as really a progressor in that industry. And you can see how now you automatically just naturally think steps in a day is a measure of health.
The world is moving on and maturing, and while you may not think it or understand it, your mindset is moving with that as are many others. Steps where an interesting concept and it is a measure, there are other elements out there that we must consider. Let me give you an example of pre and post COVID. Of those people who have had COVID, it is estimated with some data certainly, that about 25% of those people have developed arrhythmia. And going unchecked arrhythmia can lead to stroke or heart conditions that you may not know about. It is in your interest going forward that you might want to know more than just step count about your health. That's one example.
Another piece that's really on our mind even before COVID is what we call physiological stress. Pre COVID, a lot of corporations in America in particular, we're starting to get concerned with the always on society of people not being able to switch off at night from email or communications, et cetera. And it's leading to physiological stress within the body, which has an effect. If you don't switch off, if you don't recover well, then other ailments and illnesses can occur.
A really great company in this space that's been focused on this side of aspect of medical condition is Whoop right at Boston, who don't focus on necessarily arrhythmia or heart rate, but they look at stress and they look at recovery. They do it a lot for sports folk, however it applies to you. And if you could start to understand that you're working when you should be working, you're resting and recovering when you should be resting and recovering, we will all have a lot less illness longer term, whether it's physiological, physical or mental illness. And that's the way the world is starting to look at this, that there are many more conditions beyond steps that we should probably be looking after ourselves with, Justin.
Justin Steinman (08:19):
That's really interesting. There's a lot that I want to unpack there. The first question, Al. You here brought up two scenario. I want to dive into, both the COVID and the Whoop scenario. In the COVID scenario, that's really frightened that almost 25% of people could develop a long-term heart condition. Not surprising, but scary. Do you see a world where my doctor or someone else's doctor is issuing them a wearable device that they go home with? So you go see your doctor, he says "Here, you got to wear this 24/7 so I can know what the situation is."
Alan Foreman (08:50):
Absolutely. The other feature of COVID, in North America for sure was pre COVID, it was less than 5% of people had used or were confident in using telemedicine. Post COVID, the data has settled in over 70% of North Americans are using or are confident to use telemedicine. Now the only challenge and enabler for telemedicine is right now it's often a telephone call or a video call with your practitioner.
Imagine if that practitioner not only could ask you questions and you could respond by saying, "I've got a sore head, or I feel a little bit fuzzy." Imagine if they could look there live in real time at your physiological makeup as if you were sat beside them in the hospital, hooked up to that 12 lead wet electrode system. Well, the idea of putting a wristband on someone in their home and getting the same quality of metric means the doctor can do just that. They can diagnose from a distance, and that's the power of this. We all have the ability to look inside our own health, not necessarily would you and I know what that means if you had that data in front of you, but a doctor could through telemedicine. And I think that's a really important and exciting opportunity for us all.
Justin Steinman (10:13):
I think it is. But I think it also creates a really interesting challenge, what I like to call separating the signal from the noise. I'm wearing my Apple watch and spotting my pulse and thank God I'm at a good rate. And my doctorate frankly doesn't care what my pulse rate is today. However, if my pulse rate spiked to 200 every hour on the R for 36 hours, my doctor surely wants to know that. How do we set up the algorithms to identify the signal from the noise?
Alan Foreman (10:44):
Justin, that sounded like a leading question. And that's exactly what B-Secur's software does. An awful lot of technology that's out there today is absolutely good enough. And if you're in a hospital setting with a 12 lead electrode taped to your chest area, you will get the highest standard of reading and metrics from that. The problem is if you take that technology and take it outside into the home or in the everyday environment where you and I are talking about a wrist worn device, you're going about your everyday business, you're driving a car, you're walking, you're taking regular coffee or other situations, it's very, very different to wades through what data is the underlying diagnostic for who you are versus what's a general noise from what we call motion artifact by moving around or indeed other irregular data. And in the industry today, the medical industry in particular, to be able to translate from a consumer device into a medical diagnostic, you need to look at a lot of the data and take that out.
And the only way to do that generally today is by medical professionals, cardiologists, physiologists, who sit down and stare at a data read and determine actually that piece was to do with Justin walking up some stairs. And quite honestly, we can't... I use that for understanding if Justin has arrhythmia on a continual basis. We've got to get rid of that noise and that's what we have put most of the last five years of our investment and R&D into be able to, from a machine learning point of view, take out that noise and make it fit for purpose for every day scenarios.
Justin Steinman (12:41):
So you're more of a software company than a hardware company?
Alan Foreman (12:44):
Completely. We like to use the phrase, the intel inside of biosensing. What we do is we're the software that can go into anyone else's technology, whether it's smart watches, whether it's medical devices, and provide them with improved signal quality, improved on time, reduced motion artifact noise, and other factors to give the very, very best quality signal. When you get a quality signal, then you've got higher quality data. And what you do with that data can absolutely be extended to more features, but also more certainty that the data you're dealing with is of the highest quality for diagnostic purposes.
Justin Steinman (13:29):
Got it. We spent a lot of time talking about the consumer, but you just mentioned the hospital angle of it. What's the value add? EKG is an old technology, relatively speaking, and [inaudible 00:13:41] there's been a lot of optimization in the hospital scenario. Everybody's been the hospital at some point by an EKG taken. What's the next evolution going on for that in hospital for those high end medical devices?
Alan Foreman (13:54):
Well, they are expensive and they're high end because they cost a lot to develop and to put into a very, very small number of hospital environments. And as well as the technology that exists in that hospital, that hospital bad needs a trained cardiologist or physiologist looking at that data side by side. It's a really, really expensive procedure for the very, very few people in society who can either afford it or have been able to get there before an event has happened. And therefore it's not for everyone and not everyone can get to it, can afford it, or what have you. What the medical device companies would like to do is to bring that type of technology closer to a larger consumer base, a larger patient base for those that just simply can't get in the hospital or who want to do this in a more continuous and realistic manner every day in their own homes.
The medical device companies are starting to look how could they do that outside the hospital, and they deal with the same motion artifact discussion that we've just had about consumer whereby you're not sat in a hospital bed very still, very calm with 12 leads strapped to your chest area. This is going to be on a one or two lead system, maybe on your wrist, maybe on your upper arm, maybe a patch on your arm or a halter monitor that exists today. But there are improvements to be made to make that happen. And a lot of it comes down to signal processing. Not all, but a lot of it can come down to signal processing and optimizing that side of it. Once we get that right, then we can do many more things. Does that make sense, Justin?
Justin Steinman (15:46):
Yeah. What are some of those many more things?
Alan Foreman (15:49):
Okay, touched upon it earlier, physiological stress is a really nice one I like to talk about. When an ECG is taken, it's generally measuring heart rate variability, maybe tachycardia, bradycardia, arrhythmia, atrial fibrillation. Some other features of the human body that are interrelated here is the amount of pressure you're on a day to day basis, otherwise known as physiological stress. And it's not something that we measure for in the hospital environment today. We do on very rare occasions if there's a symptom that might lead us to that. But these things are all interrelated. For example, we know there are some early indications that long term physiological stress can lead to other ailments, including the onset of certain heart conditions, but also the onset of potential other diseases related to cancers, for example.
Now there's some studies, it's early days on understanding clinically if that's true to form and if all the data exists to really verify that, but there's a strong, strong indication that physiological stress is intertwined in your physical wellbeing and your mental wellbeing.
We've been running studies and for example, acute one that people will relate to is we used our technology to continuously monitor several individuals over the Christmas period and to understand what happens to you day in, day out. Not that situation where you're in a doctor's surgery for 10 minutes with an ECG and you're sat very still, but in those every day scenarios where your heart rate, as you and I might feel it, races up and down, but there's something else happening, it's physiological stress. It's that burn inside that's about anxiety. It might be financial pressures, it might be pressures dealing with your family. It might be ironically, over Christmas we found that the time at serving Christmas dinner was an extremely tense time for certain people in family.
And it's all of those things that start to lead to other conditions. We don't have all the evidence, but we have strong indicators thus far as we step into new clinical trials to demonstrate the correlation between physiological stress and perhaps stroke and the onset of stroke, or perhaps heart disease or heart failure, which is very, very interesting indeed.
Justin Steinman (18:27):
Yeah. I think everybody has found the holidays to be stressful, and I think we have all experienced the racing heart or the anxiety of sitting down with your in-laws for dinner. I love my in-laws in case they're listening, but yes, we all have that experience and that stress, but who's treating this right? Great, you're clinically documenting what I think we all intuitively know, and I think there's a lot of value in that, particularly and maybe hopefully quantifying it. But does this mean that people, psychiatrists or psychologists are going to be getting into this? Is this going to be your primary care physician who's going to call me up on January 5th and go, "Hey, Justin, you seemed really stressed out during the holidays last week, what's going on?" What do we do with all of this?
Alan Foreman (19:10):
Great question. Not to pass the buck. Our first job is to bring quality data. Data that we can do something with. The next job is to figure out how our already challenged healthcare system can deal with that effectively. And I don't think we have the answers to that.
Let me give you an example. Over here in the UK, we work under the National Health Service and any more instances of people being diagnosed with heart disease will not help that situation. It'll just lead to longer wait times, arguably. However, there is a growing train of thought around physiological stress that I mentioned, sometimes relates to systemic fatigue, which is another measure that we can get out of really great data coming from your heart, which starts to look at can you do stuff yourself? Did you know that the fact that you had very, very disrupted sleep last night is leading to higher instance of physiological stress and higher probable onset of arrhythmia or stroke related disease?
If you start to portray that, maybe you can do something about it. We've had a really interesting study run in clinical trials over in the UK where we've been studying carers of patients and often these people are under immense levels of stress and they don't know it because they turn up every day.
We've been able to point out some areas where they need to take life a little bit easier to get better rest, and quite frankly, work less hours through their own medical support staff. And that actually has a knock on effect where they're able to perform better in their job. And guess what? It may just prevent the carer take anil, which means the cared cannot be cared for, and the knock on effect and so on so forth. We find this in the workplace as well. North American in particular, there's a big instance of health insurers and employers looking to start to want to give their employees by their employees, asking them regular and more meaningful health insights.
It's that type of thing, how stressed are we and can we... I know some of the consumer tech companies that we're talking about, their employees are required to wear some of these devices for internal testing, but feedback is given to them, if they're not getting enough sleep at night. Feedback is given to them if they're not getting enough rest and recovery because inevitably they're not performing as well in the job. And that all leads to long-term illness in the workplace for more vulnerable people cared or the carers. And you can see how it then affects. There is an opportunity here for people to start to take care of themselves a little bit better. I don't know how the healthcare system will deal with the more serious conditions yet, I know they're all looking at that problem to try and fix it.
Justin Steinman (22:27):
Yeah, I think that's really interesting. When I get my eight hour sleep and I wake up, my Apple watch is like, "Hey Justin, congratulations for getting eight hours sleep. You're going to have a good Tuesday." I like that. It makes me feel good and then I go about my day. And I totally get what you're saying when you have these employees of whether it's a Fitbit or Whoop wearing the devices and getting it, but there definitely seems to be a gap still out there of yes, we can now capture that you're highly stressed and it's actually physiologically manifesting itself and we can now be alerted. But until we close that last step, that last gap, I'm not sure what we do about it. Does this become a benefit that my employer wants or offers? Boss says, "Hey, everybody here gets a free Whoop bracelet and then we're all going to monitor you for stress." Well, hold on. That seems kind of big brotherish. I don't know if I want my boss knowing how stressed they're not stressed I am.
Alan Foreman (23:22):
That's exactly right. I love that. Well, whether you can join the dots here and the data that's coming out then can be forced or used in some way, we know there's definitely a gap today. There is one very, very large employer globally. It's an American company, been around for many, many of years, and in Europe they've recently employed a quarterly wellness day. And that's to counter in a post COVID world what they were finding, where people were getting to the point of, call it barite for want of a better term and having to take sick days. Instead per quarter, they're given their employee a new wellness day. Don't have to do anything but take that day off because we recognize that you may be under more pressure than pre COVID, other pressures on your life, whatever it is, cost to live in crisis or whatever today, and therefore add in that extra day. There's where you can now attribute a benefit that an employer could give.
Does that one extra day of walking your children to school or getting a little bit of fresh air or catching up on those tasks that you otherwise have to squash into Saturday and a Sunday, can that help? Absolutely. It can help. And it's proving to help with staff morale, staff engagement, and there's a lot of companies looking at this data very, very carefully. I think we're going to see a lot more of it, Justin.
Justin Steinman (24:54):
Yeah. The questions is who owns that accountability? I don't want my employer to own it, am I okay if they outsource it to my insurance company? My employer offers, at least in the US, health insurance, and if the insurance company says, "Hey, we'll manage Justin's stress for you and we won't tell you employer what's going on," maybe that is an option, or do we figure out a way to connect the device with my primary care physician so that he can manage that for me? And then it gets back to the signal noise conversation we were having about 20 minutes ago. It's almost like we've created this technology and this information, but we haven't quite figured out what to do with it yet. But it's coming.
Alan Foreman (25:38):
You are right. We haven't figured out what to do with it yet. And yes, it is coming. And the question is, do we take that leap of faith? I remember biometrics, as you know, have been around forever, fingerprint, voice, iris, face recognition, and there was a real big issue in the world about sharing that type of personal data related to your identity from biometrics.
And one thing that happened, a company called Apple launched the Apple iPhone 6 in September, 2014. And whilst others had tried to put biometrics into laptops for years and other forms, they really hadn't been popular because of the data privacy and the sharing of personal data. But somehow Apple managed to make this popular. And was it just the right time when people were getting access to too many apps and it was more convenient to start to use fingerprint instead of have to type in that repeated passcode?
I don't know. But eventually the walls were broken down on that very issue in a different market for identification, authentication for biometrics. We're now talking about health and wellness information using biometrics. And I think we're facing that same issue right now. Somehow we know that extra data can be valuable to us all. I would like to know in advance if I was vulnerable to a stroke, because timing is everything. I wouldn't like to know, quite honestly, if I was prone to stress and I should be doing something about it.
But I just don't know how that's going to transform yet. And I think I, from B-Secur, am not the only one tackling that it's healthcare systems around the world. It's all of these telemedicine companies that are popping up. It's the large tech who are investing significantly into healthcare now. They're all faced with that issue along with data privacy, which is for a long time being an even more significant issue than probably this podcast forums today, Justin.
Justin Steinman (27:46):
Yeah, it's a really interesting topic and I want to think that we're going to see a lot of evolution happening over the next five, 10 years, and I think the beginning of this waterfall of information.
Before we go here, I want to shift topics and a little bit of a right turn here, but this is a really fascinating one to me, so bear with me. A lot of our listeners are commercializing their own medical device or their drug. And in the US, commercialization's a highly regulated process, closely monitored and supervised by the Food and Drug Administration. B-Secur, in case listeners have been listening to your lovely accent, is headquartered in Ireland. What in the world was it like commercializing a device for the US market from across the Atlantic Ocean?
Alan Foreman (28:30):
Well, Justin, I'll take that as a compliment as opposed to an insult. We're not just a field with lots of sheep over here.
Justin Steinman (28:38):
Definitely a compliment.
Alan Foreman (28:40):
Okay. We achieved software clearance from FDA and we achieved that just under two years ago. Normally, FDA clearance is given to a system which would have a piece of hardware plus software using data in a particular use case. We achieved a much broader clearance because of how our technology performed across many others technologies and went embedded into many others technologies.
What does that mean? We got a proof point and we've got some very clever people, some very clever engineers over in Belfast, Northern Ireland, and we were able to develop stuff that passed the must with the FDA. And that's no small thing. It was done in December, the same month that all the COVID diagnostic tests or the viral injections were being approved. They were busy with other things, but we also achieved something very, very good.
What it means is we can now supply this software to a provider of medical devices, who can fast track an element of their FDA clearance or their certification. Our software comes with the clinical trials and the data that was used to approve it, and that bit can be put forward to the FDA when they're getting their own system cleared. It speeds up one element of development for either a consumer tech company or a medical device company. They still have to do their own accreditation, but it certainly speeds up and provides them data to be able to fast forward some of their own development. Does that make sense?
Justin Steinman (30:29):
It does. And how did you do that? You are in the middle of COVID, planes weren't flying, how do you get certified in the US from literally halfway around the world?
Alan Foreman (30:39):
Yeah, we started clinical trials about two and a half years in advance of the certification. It wasn't just sprung upon us. And today, back and forth, we sit with the FDA online and we had done that prior to COVID anyway, so we're passing data sets back, we're passing clinical trials to them, and the data was minding up. They were coming back with challenges and eventually with all our predicates.
We have a belief in the UK that they probably made us jump through several more hurdles that maybe a better known company from the US or someone with a prior record of FDA clearance may not have had to have done. And that's very understandable. But we put forward some of the highest quality data and performance in real life testing that we believe existed in the market on that day, and that's why we got clearance.
It's simply saying our technology can be believed in. It's extremely high grade, and notably it's at the software level, and this is really important for listeners to understand, this is the Intel inside concept. In theory, you can embed our software into your technology, you can take our software from the cloud and use it with your existing technology and get many more insights through improved signal processing and improved features.
Justin Steinman (32:12):
Is the US your only market?
Alan Foreman (32:15):
Oh, no. It just happens to be our largest market that we serve, but that's forever in a day, being a tradition, you guys spend more on healthcare than anywhere else. Europe is a big market for us, and also India is a very large market for us. A quick insight there, whether it's consumer device or medical device, today India has 300 million people that are considered middle class. That's a very different statistic to even three, four, five years ago. And people that are designated middle class have slightly more disposable income and they're looking for consumer technologies amongst many other things that they look for as their economy matures.
The market, whilst we might have a cap in North America on your entire population and who can spend what on consumer devices, India is fast growing in its middle class and the people with disposable income. It's a fascinating and differentiated market and it's a huge one for us. It really is.
Justin Steinman (33:29):
It's really interesting. Alan, this has been a great conversation. I've certainly learned a lot. I got one more big question for you before we let you go.
Alan Foreman (33:35):
Go for it.
Justin Steinman (33:38):
We've talked a lot about consumer companies moving into the medical space and you coin this wonderful term about the medical consumer. Apple, Google, Amazon, are all becoming healthcare companies almost like every day. My question for you is, can a consumer company actually succeed in healthcare?
Alan Foreman (34:02):
Wow. Right, I'll be interested in who contacts me after this podcast is released. The short answer is yes. At one point in the not so distant past Medtronic were a young company, Abbot Labs, were a young company, Boston Scientific were a young company, and many of the telemedicine companies didn't even exist five years ago. They have all been able to start from somewhere and do something great.
Apple, Google, Amazon have an advantage of, they know how to invest, they know how to invest well, and you're seeing it happen with all of those companies at certain scale. I don't think it's an if, I think it's a when will these companies become medical companies. And dare I hasten to say we've spoken today simply about very large US consumer companies and very large US medical companies. If we look at the landscape as being much larger than the US, could there be value in one of those very large technology companies partnering, acquiring, or being acquired by one of those very large medical device companies? I can see that happening before long, Justin.
Justin Steinman (35:23):
Wow. That's a whole topic for a whole other podcast, but really interesting idea as to where the market is going. Alan, this has been great. I really appreciate taking the time to talk with me today.
Alan Foreman (35:33):
Justin, lovely to talk to you. Thank you.
Justin Steinman (35:34):
And for all our listeners out there, thanks as always for listening to Definitively Speaking, a Definitive Healthcare podcast.
Please join me next time for a conversation with Dr. Andrew Norton, Chief Medical Officer at Onco Health. Andrew and I went to high school together, and then we lost touch for about 25 years before reconnecting recently. Andrew's a Yale trained global expert in brain cancer, and Andrew and I are going to chat about how we can bend the cost curve in cancer treatment while still maintaining the compassionate care that every patient deserves.
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