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PASSIVE HEALTH MONITORING: THE FUTURE OF CLINICAL RESEARCH

 

ERT’s Jason Eger and VPG Medical’s Jean-Philippe Couderc dive into the limitless potential and promise of passive health monitoring in the clinical trial industry.

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episode Notes:

 

Introduction [00:50]

We welcome Jean-Phillippe Couderc from VPG Medical as he joins Trial Better to discuss passive health monitoring and VPG Medical’s technology, HealthKam.

What is passive health monitoring? [02:02]

Passive health monitoring, or opportunistic monitoring, embeds sensors into technologies that a patient uses in everyday life – like smartphones, bath mats, and toilet seats. These devices allow for multiple points of data collection and place minimal constraints on the patient’s life. Typical remote monitoring technologies require a patient to take responsibility of the device, adding a constraint into the patient’s normal activity. For example, a patient using an Apple Watch is responsible for charging the device and remembering to wear it every day. Passive monitoring addresses this challenge.

What are some of the challenges of passive health monitoring?[04:25]

Since passive monitoring technologies don’t disrupt the patient’s lifestyle or require any behavioral changes, you need to ensure the sensors will be used consistently. This requires identification of devices that the patient naturally uses on a daily basis, which may change based on certain demographics or the patient’s routine.

How do we ensure high-quality data from opportunistic monitoring?[06:50]

With regular monitoring, you have more reliable, good quality data (for example, measurements from an ECG electrode making direct contact with the skin.) However, these methods also have shorter monitoring periods with physical constraints. ECG patches can only be used for up to 15 days because the connection between the skin and electrode loses viability.

With passive monitoring, the sensor is far from the patient, so external factors have more of an impact and you have less control over the data quality. However, artificial intelligence algorithms can be used to identify which data is actually valuable. Because passive health monitoring constantly collects data, you have hundreds of measurements; even if 50% of the measurements aren’t usable, you still have enough valid data.

How do patients feel about privacy with passive data collection? [09:03]

Technology today is designed so the patient’s information can be kept private, and there are solutions to avoid sharing PHI. For example, data can be encrypted, or technologies can be designed to collect only information related to the study (and not the patient’s name, address, etc.) Data privacy is changing, and the relationship consumers have with their data is, as well; patients are more comfortable with sharing their data than ever before. In some cases, patients who are terminally ill may be willing to sacrifice their privacy because the potential value of the information collected outweighs their concerns.

What is HealthKam? [11:45]

HealthKam uses the cameras embedded into smart devices to monitor your face and extract information about your pulse. As the quality of these cameras has increased, it has paved the way for passive health monitoring solutions like HealthKam. Each time your heart beats, it effects your blood pressure and causes a subtle change in the color of your facial skin. HealthKam’s unique technology detects these changes and extracts the person’s heart rate without touching them.

How does HealthKam work? [14:16]

HealthKam uses facial recognition to identify the patient, and then passively runs in the background while the patient uses their device. This technology isn’t restricted to smartphones (which patients may only use for short periods of time), but other devices like tablets, which may be used for longer periods, such as the duration of a movie or TV episode.

How will passive health monitoring impact the clinical research industry?[17:00]

Most arguments focus on the burden micropayments can put on sites. It’s yet another technology that sites have to engage in, and it can be difficult to go through the set-up process and train staff. However, sponsors need to consider these things not just with micropayments, but all with technology, so it’s important to take a step back and determine if micropayments can provide a benefit to the trial.


Transcript:

 

[Intro]: Welcome to Trial better, a podcast series where experts discuss clinical trial best practices and take a deep dive into the latest industry trends. On today’s episode, we explore passive health monitoring. What is it? What are some of the technologies making it possible? And how will it change the future of remote patient monitoring? Leading this conversation is our host Jason Eger and guest Jean-Philippe Couderc. This is an episode you won’t want to miss and as a quick note, if you have a topic idea or question you want answered on the podcast, please leave us a comment on Apple podcast or your favorite podcast channel and we’ll address it in our next episode. So without further ado, let’s jump into this edition of trial better.

Jason Eger: [0:48] Hi, everyone, and welcome to the trial better podcast ERT’s podcast that explores industry best practices and advancements within clinical trials. I’m your host Jason Eger, Director of Organizational Readiness for ERT. In  today’s episode, we’re really excited to welcome Jean-Philippe Couderc, CEO and co-founder of VPG Medica,l JP, we’re really going to dive in today and what we anticipate may play a huge role in the future of clinical research, passive health monitoring, and your technology, specifically healthcare. So JP, welcome, and thanks for joining us and the trial better podcast.

Jean-Philippe Couderc: [1:19] Thank you, Jason. It’s really a great pleasure to participate in these podcasts and I look forward to talking more about what we have developed in these past five to six years.

Jason Eger: [1:29] Well, thank you. And maybe you could start and just tell our listeners a little bit more about yourself?

Jean-Philippe Couderc: [1:34] So my background is in biomedical engineering. I’ve been actually working at the University of Rochester Medical Center in New York for the past 20 years. I have a position of Associate Professor of Medicine there. I’m Chief Technology Advisor for ERT and a couple of years ago, I started this company called VPG Medical, I founded and I’m leading this company today in which we are developing unique monitoring technologies.

Jason Eger: [2:01] And so I know we’ve talked in the past and you talked about monitoring. The one that I think our listeners will be really excited to hear about is passive health monitoring. Can you tell us a little bit about what it is?  

Jean-Philippe Couderc: [2:13] Sure. So, passive monitoring is, we call it also, opportunistic monitoring. It’s actually when you embed sensors to measure either functional or physiological data into everyday objects, into objects that people use everyday. But not only that, what you actually do is design technologies that do not create any constraints on the patients that your monitoring or the people you are monitoring. An example is the watch, everybody knows now we have Fitbit, we have Apple Watch, and those devices have the sensor so what you have to do when you want to be monitored put this on your body everyday. You have to charge the watch every day or every couple of days. So it creates basically some constraints on people being money toward in passive monitoring, we try to address this challenge we try to reduce the constraint on the people that are monitoring the way we do it is that we embed the sensor in everyday objects, it can be your smartphone, it can be a mat that you put actually in your bathroom that does certain type of measurement when you step on it, it can be a toilet seat, for example, we’re working on this project where sensors are embedded into a toilet that is connected to internet and measure a lot of very interesting physiological signal. So the passive monitoring is something that I would describe beyond wearables. It’s  the new generation of monitoring technologies that avoid patients to think about the fact that they have to do a procedure to be monitored.

Jason Eger: [3:59] So JP, I understand the limitations of wearables and you’re trying to make it easy, right? That’s what the passive is really about just making it easy so that a patient doesn’t have to take action. It’s there, it’s going to take to collect the data from them. 

Jean-Philippe Couderc: Yep.

Jason Eger: So we’ll definitely get into talking about healthcare. And I definitely, but I want you to talk a little about to the users are what are some of the challenges, before we get into talking about exactly what health care is, what are some of the challenges of the passive health monitoring?

Jean-Philippe Couderc: [4:28] So the Passive health monitoring or again opportunistic monitoring means that we have to ensure that these people use the subjects, okay. So, in general, the passive monitoring is something that is not actually creating changes in the life of these people, but it makes the assumption that these people use this device. So what does it mean means that for example coming back to the smartphone, the usability and the way people use their smartphone is very different, you know, between somebody that is 70 years old or above and a 25 years old, a young individual, okay? The new generation spends hours on them. And if you have like healthcare technology that passively measures their cardiac activity through their phone, and we see that we have hundreds of measurements every day, okay? 

Now, if you go to actually somebody that is over 75, and got a smartphone the past couple of years and are used to flip phones, they are in general spending a little bit less time on these devices. So it’s less opportunities to acquire so much data. so this passive monitoring is very dependent on how people live, what are their routines, and how the integration of these everyday object or actually using their life, and this is very variable between individual. So there’s a limitation or I would say a constraint here, where you want to make sure that when you do passive monitoring, you put your sensor in the devices, in the everyday objects that most choose or use on a regular basis. 

One other example is this toilet connected seat where the sensor is put on the toilet seat. And obviously like as everyone needs to use them every day, you ensure that you have this information connected. And here I’m talking about weight, temperature, ECG, and many other physiological signal that can be extracted from a toilet seat by putting it in this very specific object to ensure that it is used on a regular basis, on a daily basis. That’s this kind of concept that I think is very powerful and obviously again, when you do that, you’re not asking the patient to do anything different than what they are used to doing.

Jason Eger: [6:48] Understood. And so with this, JP, so one of the questions that comes into play is, okay, well if it’s passive, how high quality is the data? So what are your thoughts on how do we ensure we get to higher quality data with this opportunistic monitoring?

Jean-Philippe Couderc: [7:07] So indeed, what’s happening is that the further you go from the patient when you do the recording, the more noise you acquire, okay? When you have usually a sensor like an ECG electrode that sticks to your skin, obviously, this link to the patient is very strong, is very reliable and the data is a good quality all the time. And unfortunately, in this example, you cannot keep you know a patch for more today than 15 days you have to change the patch regularly because this interface between the electrode and the skin is not viable after a couple of weeks. In passive monitoring, we actually have the sensor far from the patient or the individual, which means that you have many external factors that are going to be affecting your measurement. So what you expect is that in passive monitoring, you have less control on the quality of the data you are acquiring. And how do you solve this problem? You develop actually AI, you develop algorithms that help you by filtering out everything that is low quality is what we do in healthcare and I’ll talk a little bit more about that. But when you think about sensors that are not touching the patients, you have to have control over the external factors that affect your measurements. You have to measure them and use them to really assess whether the measurements you have done are reliable enough. 

So it is a new area I would say where the noise is much more present. But on the other end, because you are passive, you’re opportunistic, can you put that in a device that people use every day, multiple hours a day, in certain cases, you have hundreds and hundreds of measurements. So losing 50% of them, 70% of them, it’s not a problem because you still have a lot of them that you can use throughout the day.

Jason Eger: [9:04] Right. And still with that quantity of measurements, do you think that we face any hurdles with regards to patient privacy?

Jean-Philippe Couderc: [9:15] Or patient privacy? You know, of course, when you put a sensor in everyday life that’s the first question. Okay. And I think the technology is designed to where this information can be kept private, with many, many tools and many ways, in many ways. For example, at VPG Medical, when we do our measurements, we have no private health information that is passed from the device of the patient to our server. This is first all encrypted first and also we do not include any kind of names of PHI It is just actually the measurement that is associated with an ID that actually flow from the sensor, from the smartphone from the tablet to our cloud server. So there’s always actually opportunities and solutions to avoid that, you know private information, PHI is actually flowing between the different technical entities in the monitoring concept. 

There is another aspect. So I’m speaking more about cyber-security, I guess, here, but there’s also aspect in a sense that we know this phone today measures a lot of things when you know, people know where you are, they know what you’re doing in general, to all this information is required by another organization. I mean when you look at Facebook, for example, this is the, you know, interesting example of how this technology has actually changed how privacy is defined in an individual, I would say, and there are many challenges today that this company is facing. It’s true for Google in Health care also. So privacy is going to change over time, there’s no question but I can tell you, based on our experience when we explain how healthcare works using the video, and having the smartphone looking at people all the time, when we present this concept to patients that have chronic disease that actually get value from their everyday monitoring, they really in general, do not have any concern about privacy, the value they get from these monitoring from this passive monitoring is way above the problem of privacy that some people may think about, we run new phase that  

Jason Eger: [11:40] Understand, it’s the benefit of the technology versus the privacy. Now I get it. So JP now the real exciting part and the part that I know you love to discuss is the technology. Let’s talk a little bit about Health Cam, and how does it work? 

Jean-Philippe Couderc: [11:55] Yes, so indeed Health Cam is a very unique technology and it is actually, as I already talked about it a little bit, is using the camera that is embedded into small devices. So today, as everybody knows, you buy your laptop, you buy a tablet, you buy the smartphone, you have cameras everywhere and it’s not going to change. It’s going to be more and more prominent in everyday life very soon. I have no doubt that when you come in a room, you will have a camera and it exists already in many places. You have a camera in the room and you can connect with your laptop or device to this camera and have access to the images. So cameras are everywhere. We know they are everywhere. We know they are going to stay there. And very interestingly, what happened in smart devices, the quality of these cameras are extremely good. Okay. The reason is very simple, people wants to have beautiful selfies, they want to take beautiful pictures and share that with the world. But what we’ve done at VPG Medical is that we actually leverage these high quality cameras to do passive monitoring of cardiac activities, the way it works is a little bit surprising and interesting. 

Each time actually your heart beats there is obviously changes in the in the blood pressure and this changes in blood pressure affects the way the light is refracted and reflected from the skin and this is actually very important on the face because the face the skin is thinner than the rest of the body, at least in general. And each time your heartbeat you have subtle changes of the color of the skin that is due to this variation of blood pressure underneath the skin. This is what I would call a blushing phenomenon that happens on a B2B basis. But that is so subtle that obviously we cannot see it with the naked eye. What we do at VPG Medical is that we use this unique technology we developed during the past seven years in collaboration with the Rochester Institute of Technology in the University of Rochester, New York and these technology detect the subtle changes of the color of the skin. So each time we take a video of the face of the patients, we now have the ability to extract the heart rate of the person without touching the person just using a video camera.

Jason Eger: [14:14] So JP, real quickly is it just literally if I’m holding the phone, if I’m using a technology, and I’m holding the phone, and I’m looking at my phone, is the camera they’re rolling and censoring my face?

Jean-Philippe Couderc: [14:27] Exactly. So that’s what is also very unique is that this technology works in the background of your phone is that again, this is passive, you don’t have to do anything. As soon as you put your phone on, and you basically open your email or you look at your Facebook page, Healthcam application, grab the camera, look at your face, recognize who you are, we have face detection and face recognition. And when we know that it’s you, we are detecting actually these Heart rate will disperse rate on a B2B basis during the time you are interacting with your smartphone. 

So a smartphone those in recording can be you know very quickly in general you take a smartphone you look at an email a text message you don’t spend more than a few minutes. But every minute is actually two recordings for us. But we also have this technology that works on tablets working on tablets, okay. And on tablets, people use them for other purposes such as watching their favorite TV series on Hulu or Netflix. And think about it. They spend hours looking at these programs or even reading their favorite magazine or interacting with this device. And again, every 30 seconds we do a measurement of pulse rate, every 30 seconds we spend looking at their screen, we have our app looking at them and measuring their pulse rate. 

So we currently have clinical trials and clinical studies ongoing. Our largest one is funded by the NIH. We are enrolling currently 300 people. 300 patients actually with atrial fibrillation. We demonstrated already by that with this passive monitoring, we can detect the presence of atrial fibrillation, okay. So because we detect the beat to beats per session have someone we can actually gain insight into the viability of these parts and the viability of the pulse gives you insights into the electrical activity and the presence of atrial fibrillation that leads to large viability of both. That’s exactly what the Apple Watch, for example, is doing with the photo plus the small graphics detection they have in the back of the watch. We are doing something very similar, but we use the video camera of your smart devices. And again, you don’t actually need to wear a watch. You don’t need to put a device on you. You just continue using your tablet, your smartphone as you do during your regular activity, your daily activities.

Jason Eger: [17:02] I mean, that’s amazing JP, really it is. I think for folks that haven’t heard of your technology,  they’re going to be extremely impressed. And we’ll give some information at the end associated with this podcast about where they can find more information on Health Cam and VPG technology. 

Jean-Philippe Couderc: Thank you. 

Jason Eger: Thank you now. So where do you think JP that we’re going? Where’s the industry in general going in terms of these new technologies? 

Jean-Philippe Couderc: [17:29] Well, Jason and I think we are actually living in a very exciting time. We see these wearables really being developed for many applications, doing many things and in a sense, they are providing more information and different information than what we have actually accessed today. So again, it’s a very exciting time. And with this new concept we’ve developed at VPG Medical with health cam, with all the concepts of passive monitoring and open journalistic monitoring, we believe that the integration, and the genesis of this data will be easier and stronger. And when we think about either wearable passive monitoring and all these new devices that will be embedded in everyday life objects, we have an ability to really change medicine, we have an ability to help all stakeholders in the domain, I’m speaking about healthcare providers, including physicians, nurses, and other and for the clinical trial space, we have really an ability to enable new ways of acquiring information and assessing the efficiency and the safety of new drugs on your devices.

Jason Eger: [18:51] JP, so innovative, so informative, thank you so much for joining us in the Trial Better podcasts and sharing your expertise. Today we learned about power passive health monitoring, the challenges associated with wearables where the future of passive health monitoring or opportunistic monitoring, I believe you called it, where we’re going with it in the industry, and really gave the real life example to our listeners of VPG’s extremely impressive technology Health Cam. So I know I personally learned a lot. I’m sure that everyone that’s listening also did. I wanted to thank you again so much JP, just so everyone knows. Thank you. I’m your host, Jason Eger. Thanks for coming and joining us today on the trial butter podcast. Make sure you reach out to us with any feedback or questions at trialbetter@ERT.com. Thanks, everyone. 

Jean-Philippe Couderc: Thank you.

[Outro]: That’s a wrap. Special thanks to JP and Jason for today’s discussion on passive health monitoring and the challenges and more importantly the opportunities it presents as it shapes the future of clinical trials. Thank you for tuning in. And please remember to comment, rate or review trial better on Apple podcasts or your favorite podcast channel. You can also reach us at trialbetter@ERT.com.  Your feedback helps us deliver the content you want to hear. So please get in touch. Again. That’s trialbetter@ERT.com. Thanks for listening, and we’ll see you next time on the trial better podcast.

 


FEATURED GUEST:


Jean-Philippe Couderc is an entrepreneur and scientist with experience in the development of groundbreaking technologies with multiple examples of successful commercialization in the field of cardiac safety. Internationally recognized authority in the development of computerized technologies related to cardiology. Scientific founder and Chief Technology Officer of iCardiac Technologies Inc, a company which was purchased in December 2017 by ERT.

Founder and Director of the Telemetric and Holter ECG warehouse, an initiative developed with the US FDA under a private public partnership and funded by the National Institute of Health. Holding a position of Special Government Employee at the US-FDA until 2015. Characterized by a creative mind leading to translational scientific discoveries which have been highlighted by major media including the Wall Street Journal.

For questions about HealthKam, contact Jean-Philippe Couderc, jean-philippe.couderc@heart.rochester.edu

Also find more information on HealthKam at VPG Medical.


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