(This is an unedited transcript. For accurate quotes and presentations, please refer to the full-event video.)
0:04
Hello, everyone. And thank you for joining today’s webinar, trailblazing Tech, or Dodgy device, the future of Consumer Wearables.
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I’m Kathryn Martucci, Director of Policy and Programs at the Alliance for Health Policy.
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For those of you who are not familiar with the Alliance, Welcome, we are a non partisan resource for the policy community, dedicated to advancing knowledge and understanding of health policy issues.
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1:02
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Then finally, please be sure to check out our website, all health policy dot org where you can find background materials that accompany this webinar, including slides, a resource list, an expert’s list, and we’ll also make a recording available there soon.
1:35
And now I am so pleased to introduce Ms. Adimika Arthur to moderate today’s discussion.
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Adamika is the founding Executive Director of Health Tech for Medicaid, a collaborative convening of payers, providers, policymakers, and innovated entrepreneurs, collectively advocating for health equity and improvement of the Medicaid program on a national scale.
1:58
I mean, she’s also an experienced, a clinical epidemiologist, and a hospital health system executive. And so, with all of those wonderful experiences, we’re so glad that she’s here today to lead this conversation at Adimika, I’ll turn it over to you.
2:13
Great. Good morning, and I’m happy to be here today and really thrilled to spend some time talking about this great topic with our panel.
2:24
I’m honored to really moderate this expert panel on the future of Consumer Wearables.
2:28
As many of you know, there’s a growing demand for wearables that has generated really a booming market and how now insurers and companies are seeing how supply of wearable technology can be in beneficial. Not only their customer, their employees, but also other larger consumers. And, as a market, the US.
2:47
Consumer use of Wearables has increased from about 10%, to well, over, about 37% in just the last few years. And this number will continue to grow like wearable technology and become more conventional.
3:00
So, we are going to talk about that today.
3:02
And we have here with us today, is the fact that K are a group of a themed expert.
3:09
First, we have doctor Brian Kelly. He is the president of Payer and Provider Solutions at i.q-via.
3:15
In this role, Brian helped that that and execute the strategy for using technology to accelerate as leadership in the clinical research and provider market.
3:25
Prior to joining or caveat, Brian was the head of informatic that Aetna, and also worked at Accenture, where he led his global electronic health record practice. Doctor tell you, the former Navy neurologists, and an intensive care medicine specialist.
3:40
Next, I’m pleased to be joined by doctor Jasmaine McClain. And she’s senior manager at AvalereHealth, where she advises clients on Digital health strategy and quality improvement implementation. She draws on her deep expertise in oncology research innovations in virtual care and provider strategy.
3:57
Prior to joining Avalere, Jasmine was an Associate Director at …
4:01
Advisory Board, where she advises senior leaders in hospitals and health systems and develop devising long term operational strategies related to digital health and healthcare delivery transformation.
4:13
Next, we had doctor Van Krishnamoorthy, he’s the CEO of Tactile Navigation Tool, and in this role, doctor doctor Van, designed the engineer’s assistive technology to improve mobility for those with visual impairments.
4:28
He previously was the founder of Try and Try and Omics, and head of clinical research and operations at Trail Park.
4:36
And finally, around at our great and amazing panel this morning, we have Kistein Monkhouse, she’s the CEO and founder of Patient or a Tour, which is a digital health startup that is using a mobile app to help underserved patients document their medical symptoms, to empower their voices in their health expertise.
4:53
And she’s a public policy expert and former healthcare frontline staff who thought the urgent need to build the bridges between communities and health care.
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She’s also a patient advocate on a mission to dismantle, dismantle, systemic inequities that cause health disparities across our health care ecosystem.
5:10
Thank you all for being here with us today. I’m gonna start off with an opening question to doctor Kelly, doctor Kelly. I’m gonna start with you.
5:20
Good morning. Good morning.
5:22
From your perspective and leveraging your expertise. What is most important for healthcare professionals and policymakers to know about consumer consumer wearable for help?
5:33
So, thanks enemy came. Good morning. Good afternoon everyone. So, I wanted to start by talking a little bit about what is aware of and just sort of base flagging it for the conversation today.
5:43
So, very simply, a wearable is enabled. By, this would be in contrast to implants that are implantable. Now, there are many types of wearables. Wearables can be medical devices, For example, a hearing aid is warm and as a medical device.
6:00
If you were to wear an external vests that added the fibrillation are attached to it, that would be a medical device. But there are many other type of wearables that are consumer devices and are not medical advice. Great. Examples of these would be a smartwatch or fitness tracker that you might use.
6:19
Now, it gets a little complicated here, because that consumer device, that smartwatch or that of fitness tracker, you could run an app on that.
6:30
And that app, which runs on a consumer device, could be a medical device.
6:36
So, know, it there. It gets a little great. Now, what makes something a medical device, as opposed to a consumer device? Well, you have to go and ask the FDA. And the FDA is very clear about this.
6:51
Any device that is intended for the use in the diagnosis of disease or conditions or in the cure mitigation treatment or prevention of disease, is a medical device and typically would require approval. So, the key concept here is, is that app, is that consumer device, is that aware of all? Is that being used to diagnose or treat disease? If it is, it’s a medical device. If it’s not, then it’s a consumer device.
7:23
Now, the FDA has established classification for about 1700 different categories of generic devices.
7:33
These fall into three major categories, what I call class one, class two, and class three Class one, or things like syringes and bandages, pretty simple type of stuff.
7:45
Class two is a little bit more complicated device like a a mercury thermometer a class. three device would be something like a pacemaker that you wouldn’t find somebody.
7:57
Now, why is this important?
7:59
The regulatory process for getting approval of medical devices is based on class, or class of 1 and 2.
8:07
You would typically go through something called a 5 10 K clearance, whereas the class three device typically go through what’s called pre-market Approval, application, or PMA.
8:17
Now, wearable devices are not regulated, bought the FDA.
8:24
If they’re intended for general wellness purposes, such as as maintaining general health or general fitness.
8:34
But this is where, again, it gets a little complicated. So let’s say if it’s the first of January, and you make a New Year’s resolution, that you’re gonna get fit again, you go to your fitness club, and you get on a treadmill, or you use a stationary bicycle.
8:48
Well, that stationary bicycle, or treadmill, may actually recorded your heart rate and tell you that your heart rate for 120 when you’re exercising is that a device is not a medical device. The answer is no. It’s a consumer device because the intent of the heart rate measurement is to basically promote general health and wellness and not diagnose or treat disease.
9:15
Now in contrast, let’s say that you have a smartwatch and that smart watch has an app on the app on it. It’s specifically designed to detect an abnormal heart rate so that you could maybe want a good signal that you want to go see your doctor.
9:32
To you know, get chucked out.
9:35
That app would be considered a medical device because it is being used for the purpose of diagnosing or potentially in some other cases, treating disease.
9:46
So general wellness is in the consumer device area apps that basically do diagnosis or or make suggestions around treatment or not.
9:57
Now, where these different wearables support, thousands of apps, I mean, you can go to the app store and you will find thousands of apps that are in the medical area. And generally, if the app is making specific recommendation or diagnosis, the FDA. If want to go in and take a look at it and, and, and qualify it as, software as a medical device. And there will be a regulatory implications.
10:26
However, if you want to know, does your app need to go through this process? Or is it more in the juvenile wellness category?
10:34
There is a great website if you just go to FTC dot gov, the Federal Trade Commission website and just type in mobile health, app, interactive tool. Say that again, mobile health interactive tool. That takes you through a series of questions. Very simple, the answer. And then it tells you whether your app would likely require FDA approval, or if it’s what’s called the minimal risk to users. And the FDA is decided if it’s a minimal risk that they’re not going to regulate it. It doesn’t require you to go through an FDA approval process. And things like this are things that would help a user self manage their disease or condition. Maybe help a user organize their healthcare data, allow them to see their electronic health record data on their smartwatch or other device and things like that. There are other examples.
11:24
So, I hope that gives you a little bit of overview overview of what is a medical device? What’s the wearable? What’s the consumer device?
11:35
That was excellent, doctor Kelly.
11:39
All right. Well, next, I’m gonna bring at Jasmine, doctor Daffin McLean.
11:44
And I’d love for you, Jasmine, to give similar kind of an overview from your perspective and leveraging from your own expertise.
11:53
What is most important for healthcare professionals and or policymakers to know about continual consumer, wearables, or health?
12:01
Thank you out of Mika, and thank you, doctor Kelly, for that great overview. I think that’s really helpful, and sets the stage for our discussion today. So, as we think about the use of wearables in health and healthcare, I think it’s really easy to sort of think about the devices as a one platform fits all solution. Right, That we’re all excited. We love kinda the user interface and thinking about these gifts as the holiday season is approaching. But I think it’s really important to kind of categorize the intended use when we think about the devices. So, I wanted to dig into that a little bit more, along with the considerations as it relates to data privacy for today’s discussion. I think there are a lot of exciting opportunities when it comes to patient engagement, but I think one thing we’re really seeing is that there are new. And I think tougher challenges when it comes to data privacy and data security as it relates to the use of wearable devices. And so, you know, it can be a bit overwhelming, I think, as you kind of think through some of the things that doctor Kelly was talking about, the use, this, I want to break those up into a couple of categories, just for the purposes of discussion.
13:00
So, if you think about wearables, that can be used as a tool for kind of self driven or individually initiated behavior change. Those are the really exciting fitness trackers, like Fitbit that I think a lot of people really enjoy, and that’s an example that can help patients who are relatively healthy, as well as patients, with, perhaps, a variety of chronic diseases, to promote physical activity, through the gamification that we’ve seen in health and wellness. And so, I think there, where we hear a lot of questions from providers, is, What do I do with that information when a patient comes in? And they’re really excited about how they’ve been using their Fitbit, or have information that they want to share, what does that mean, in terms of any care planning, or decisions that I might make with that patient in partnership with that patient? And so the data’s just really messy, right? It’s hard to understand exactly what that means in terms of any changes in a patient’s care plan, or how to discuss that in a way that is both helpful to the patient, and it doesn’t add too much burden on the providers on the provider side.
14:00
The second category that I like to think about in terms of the uses for these devices, are devices that can be used to help with symptom or disease management.
14:09
And so an example there that I think is really smart is an example where Apple watches are being used to help track tremors for patients with Parkinson’s disease. And so you can imagine a world where prior to the use of an Apple Watch, you might go in, you know, every month, every couple of months to see your neurologist. But you wouldn’t be able to necessarily have objective data to share with that provider about how your tremors might change over time since the last time that you had senior provider. And so the Apple Watch is a way that you could perhaps track the tremors over time. and then use that as a tool to talk about. Perhaps how your disease is progressing as a patient with Parkinson’s disease. And so, I think that’s really important because the level of granularity that you get in terms of the data with the use of the device is completely different than what you would have had access to before. Again, there, I think there are challenges when it comes to the reliability of the data, as well as thinking about, how does that get integrated into the care planning process with the provider?
15:05
And then the third category that I think is really important is tools that are specifically used to inform shared decision making between a patient and a provider. So something I’d put in that category is a continuous glucose monitor For a patient who might have diabetes using that as a way to modify a patient’s treatment plan, and think about how you can discuss, you know, treatments that might be available for that patient. But as well as, you know, behaviors that are happening outside of the four walls of a hospital or a clinic.
15:33
So, I kinda wanted to just walk through that, because I think sometimes when you talk about wearable devices, the number of applications can be really enlists, and I think exciting, But it’s important to kinda think, across those categories.
15:44
And so, you can have devices that serve more than one use, but the threshold for evidence generation. And then also, the regulatory oversight that, that is being applied, as doctor Kelly described, is very different. And I think it should be different across those three categories.
15:59
I don’t think anybody would disagree with the statement that we have challenges with very traditional forms of health care data being shared and managed across what are called covered entities. Right, so, thinking about hospitals, pharmacies, health insurers. And so, that only gets magnified when you start to think about the number of new entrants who might have access to health related data, that is not covered under HIPAA. So, I really want to start to think about that in the context of this discussion, not only with the new forms of data and the new entrants, but the new ecosystem of data, that, we’re starting to create with all of these devices. Right. So, you have wearable devices that are really exciting. and being used along with a smartphone or a smart speaker, Right. So, you’re seeing all these new devices coming, and lots of data emerging from each of those.
16:47
And so, I think we’re all end is just really making sure that we start to keep front and center the intersection of technological literacy and health literacy when it comes to these devices. Of making sure that patients and particularly vulnerable populations understand the capabilities of these devices. And then how those can be used to help inform their own, their own health and care planning.
17:08
So, I’ll stop there and turn it over to the other panelists.
17:10
There were lots of gems in there. I mean, even I was writing down some of the things you’re talking about. Like, you know gamification and how our new ecosystem is there. So thank you so much, really insightful that.
17:23
So now I’ll turn it over to doctor Van.
17:26
Good morning, doctor Van, morning, from your perspective and leveraging from your expertise, which is pretty bad. You know, what is the most important for healthcare professionals with your one and policymakers to know about consumer wearables for help?
17:42
Thank you all. And thanks for the question. And it kind of building upon what doctor Maclean had said in terms of that intersection between the patient and every other stakeholder in digital health. So, you know, whether that’s clinicians or the pharmaceutical developer, that advice developer, and, you know, So, I step back for a moment, You know, kinda come from all of those perspectives. So, I started off really as a radiologist in Academic Medicine at Yale and Columbia. And then I thought, I could do more and Big pharma. So, spend some time there, and, you know, that kind of gave me that perspective of being on the other side of the table, the patient, And it really made me realize that.
18:21
We kind of have the power, when we’re not the patient, when, where the physician, when the nurse, the human, where the drug developer, we have a lot of power and really shaping people’s lives.
18:31
And so long, that process actually was diagnosed with retinal degeneration from a really rare genetic mutation into, know, I’m slowly losing vision. And I’m actually currently, testing was considered legally blind. And so it’s, it’s really opened my eyes, pun intended to what it’s like to be the patient. After a sudden the world experts in retinal diseases, they did an amazing testing and diagnosis genetic work ups, and then it was kind of like silence. So, what do I do next? There’s no real connection to the rest of the community, the world.
19:10
You know, whether it’s services, social work, devices, and so on, and made it really, really, it hit home that, that connection between the patient and the other stakeholders, It’s really doesn’t exist. And, we had to build some bridges between all of those, until we can empower the patient, you know, Empire something like me. And so that’s where I went into the startup world and developing devices to help folks who are visually impaired. And a lot of that is navigating what requires DFT. It doesn’t, I’d, definitely, definitely, on one extreme of data and privacy, I believe the patients really should own their data, should be able to benefit from the data they’re paying for. All the testing and care they get, And that, yes, security is important, but unfortunately, there’s a lot that’s not being done because of the fear of security.
20:03
And so I actually think it’s, it’s worth pushing those limits and sharing our healthcare data so that devices can be built it. And along those lines, the other important part that I did, I learn them from being in big pharma if at least one has it for some myers.
20:20
Did an excellent job of understanding the patient registry. Had patients come in with the disease we’re trying to treat or cure.
20:26
And we try it had them in panels and really tried to get in their shoes, even though we didn’t have the disease. And I think that perspective of the individuals most affected, and the most in need, and most vulnerable, should really be designing the solutions, and in digital health, that’s actually possible. So, you know, we’ve developed a cane, it does not require FDA review.
20:52
And, you know, as a visually impaired person, I was able to actually directly test, understand, refine the product, and know that it could have real value, and as we can expand into the more digital, electronic devices and our. For a second product, that’s when we’ll have to get involved with the FDA. But, again, being a person who’s visually impaired, I think, is critical to designing the right product. Because, otherwise, at some level, we’re always guessing what the patient needs.
21:24
Wow, really powerful and well needed.
21:27
I mean, I think the perspective of being an entrepreneur, but also additionally being a patient and understanding things from the patient perspective is really important, and that’s a great segue to our next individual on our panel and Christine. Christine, Good morning.
21:45
Good morning, Adam. Lisa, thank you so much for having me.
21:48
Yeah, so from your perspective and leveraging your expertise, what is most important for healthcare professionals and policymakers to know about consumer wearables for health?
21:59
Sure. So, through the lens of both the patient and the caregiver, I echo most of what the panelists have mentioned, or the previous panelists have mentioned. It through that lens that there is the pros of the opportunity, that wearables person, especially as we look towards measurement of data and collection of data that is otherwise lost outside of that clinical setting. And much like what we’ve done with our app, is, look at how we can leverage a qualitative data data that will help that patient improve their health and their well-being, both in and out of the clinical setting. I think the argument to be made that wearable offers innovative ways to connect with the patient and strengthen that relationship with the provider, but, more importantly, improved patient engagement and the management of their health and health care.
22:52
But I think we’re at a con lies, and I think these are things that we need to think about, not only from a policy perspective, but also from a clear perspective, is those little issues, And I call this bucket item issues one, B, and access, right? So, specifically, when I speak, I’m always advocating for our underserved, chronically ill population are people. So, when we look at low income individuals, especially those who may not have access to purchase those devices, who already have the burden of out of pocket costs, a medical fees, and any other payments pertaining to their health, we have to be careful about this issue of accessibility. Keep in mind, if the device requires the individuals to huddle wireless plan, that also add to the cost burden on the individual. So, the other piece of that, I think, one of the previous panel mentioned, was the issue of literacy.
23:46
And when we look at health literacy, and how that impacts communication, I think there’s been studies that’s proven, that literacy, actually, or low literacy, can actually lead to more hospitalization, especially for, for, for our low-income patients. And then the last piece, I think would be around the issue of privacy and concerns around privacy privacy, protection for patients, and that data that’s being collected. The patient generated data, specifically. So I think there was one study that was done by rock health, which is stated that people are more trusting of the federal government, and insurers and the farmer than they are of big tech, so I’ll leave it there.
24:34
Thanks for the time. They’re really just an insightful panel this morning. So, I wanna thank the panelists for getting started and kicking off, and what’s important to know.
24:44
We’re now going to move into the Q and A discussion for today, and remember, you can use the questions panel of the audience interface to submit your questions at any time.
24:52
And I’m going to start with a few questions that have already started coming in, and for our panelists.
24:58
So what responsibility do companies have of ensuring the equitable and safe use of data and not just making sure that data is secure? But also making sure that it’s not abused.
25:18
Hi, can you hear me?
25:21
Can hear you just fine, you’re gonna go ahead. Yes, so, I think, you know, that’s a great question, and I think it’s something that really goes back to what we were talking about earlier as it relates to how this data fits within our existing regulatory framework across healthcare. And so, it’s really challenging, because a lot of these entities are not covered by traditional, you know, things like HIPAA. They’re not covered by that. And so, I think what we’ve seen is a move toward self regulation, and the absence of kind of a clear framework for how this will be applied to these new companies. You know, these startups and tech companies that are really getting into healthcare, there has been a push towards self regulation. But I think there are a ton of challenges there, which I’d love to hear some of the other panelists thoughts on, in terms of, What does that mean for? how an organization’s incentives to be involved in health and health related data? How does that align with the ability to self regulate? I think that’s gonna be a really challenging issue as we continue to see the use of these devices emerge across the market.
26:21
Jasmine, if I could just add on to what you’re saying. I think it gives you that beautifully.
26:26
Just for the purposes of the audience, just because this, I don’t think, is always widely understood, is that the HIPAA law that’s been around since 19 96, only applies to entities that are providers of healthcare, payers, of health care, or clearing houses. Which are basically the organizations that move claims data around, and do things like that.
26:49
If you are not one of those three entities, then the HIPAA rules, which, I think, is actually a very, very good framework for protecting the use of healthcare data, and striking the right balance, between being able to use it to deliver great health care, and do great research, And, at the same time, protect the patient’s right to privacy. And confidentiality, It’s a great framework, but it does not apply to organizations that are not payers, providers, or, or clearing houses. So the real question is for all of those other entities that are not part of that group, what is the framework? And right now, there really is no US countrywide framework for doing that. The Federal Trade Commission basically have broad consumer protection rights, but but it hasn’t really defined in great granularity.
27:46
What that means, We do not have a, an industry agnostic framework for privacy in the United States. And that’s a little bit where I think some of the tension is.
28:02
Great.
28:03
I’m going to move on to the next question.
28:07
And that’s a very million dollar question, you know, Are these technologies actually helping individuals improve their health or is improving access to otherwise inaccessible or unaffordable approved medical devices?
28:20
Anyone want to chime in there?
28:23
I said this is band, so I can chime in a little bit. I think it depends on what type of device.
28:28
So, you know, for the things we’re developing, know, as a visual person, I can tell you, I personally benefit for the devices were developing, say, so, today, answer in that sense is Yes.
28:40
I think if you look at things like Apple Watch in the Samsung Watch and insert the whole fitness industry, there definitely is a gap between, you know, measurement of parameters like heart rate and blood oxygenation that the watch can do, and what the fitness person or the trainer, is helping to where, do.
29:01
That, that connection back into the healthcare system, doesn’t really exist. There’s a little bit of that in terms of some insurance companies are basically, you know, helping people to subsidize the cost of a watch so that they can plug them in into, let’s say, going to the gym every month. And then they might subsidize the costs of the gym. But I think fundamentally, a little bit different from what, you know, doctor Kelly, is saying.
29:25
Fundamentally, I think, the way you approach this is really not helping the patient, and, you know, the patient, whether it’s heart disease, diabetes, heart, disease, whatever, I think we have to go back and basically say, the patient is spending a lot of time and money to get health care.
29:42
And, how do we add value to that process to the patient, Just like with insurance payments? We have value based payments saying, you have to actually improve your diabetes if you want to get paid for caring for a patient with diabetes? I think we have to apply those same principles. You actually have to prove that the device is helping improve health. You actually have to get people to design a device that helps the individual patient and their characteristics.
30:08
So, I think the data, in terms of ownership, patients should really financially and medically benefit from sharing their data.
30:18
Right now they don’t because, you know, it’s done through this premise that as we know, we basically are giving our data to whoever wants to use it.
30:29
There’s an IRB process, Tuttle Review, that proposal.
30:33
There’s a HIPAA protection so in case that data is lost but the patient who actually paid and got that testing really benefited in no way from that. I think we have to really choose their paradigm.
30:47
You know, so we see the patient’s data.
30:49
Us to really been the control the patient and the patient can share it if they feel like it’s going to benefit them. And then when they have that tangible sort of skin in the game, then they’ll help to design better products.
31:02
And they’ll help to connect all those stakeholders like, the trainer, because that, you know, those different worlds, I’ll come back to the patient, and they don’t come back to the healthcare provider or the drug developer to come back to the patient.
31:13
Yeah, that brings up a really great next point. Privacy, right.
31:17
Privacy is a big issue, and what do you guys view as the most important areas, or what stakeholders need to be engaged, and in the privacy conversation today?
31:31
I’d love to jump in there. I think one of the, you know, challenges, you know, even as I think about this within healthcare, but I think, you know, as you talk to friends and colleagues outside of healthcare, understanding that digital footprint of what does it look like to have this surveillance based model, and a lot of ways of devices being used in your home. Going to the gym in different, you know, in the grocery store, and the pharmacy. Right? So you start to understand what does it look like to have information about you being shared across multiple entities. I think that is going to be something where we really need to focus and elevate as this. You know, series is intended to do elevate the voice of the patient and center the design of these devices, the use of these devices, and the application within healthcare settings, in particular, around what is going to best serve patient needs. And how do we ensure that patients understand how their data are being used. But important, you know, more importantly, I think, in the world of big data, how is that being aggregated to paint a picture of your health?
32:31
Think that is really important to, to consider, to think about, how do we educate and partner with patient populations? Because a lot of times, it can feel very top-down and a lot of ways of, Hey, this is what’s happening in the industry. This is the direction that we’re moving toward, innovation. I think it’s really important to just continually bring patients to the table as we develop new ideas and innovations around the use of these devices.
32:57
I’ll jump in, if you don’t mind. But what I’ll say is, as someone who lives with chronic pain and who interacts with health care providers on a regular basis basis, but also working with chronically ill and underserved patients, I think we shouldn’t underestimate this issue of trust. Which goes back to this issue of transparency. So we need transparency not only from Big tech, but also from government insurers, Perry’s, all of the different stakeholders that will be regulated and or allowing updated to move as it should benefit the patient and the health outcome of those patients.
33:37
That’s a great. And now a question about payment.
33:40
Know, flexible spending account dollars can be spent on preventative items like sunscreen, neck pillow than even lipgloss in some cases, right?
33:48
Why can’t you spend your FFA dollars on wearable devices that have proven medical benefit?
33:55
And I guess the question is that both preventative or therapeutic medical benefit shouldn’t Congress Act to correct this, then update the data or the statute, but modern prevention and treatment?
34:08
I’m sure that they’re all going to jump in on that. Right.
34:15
Who wants to go first?
34:17
I didn’t say a little bit.
34:18
So I think the bigger problem is is where is the money coming from And where is it going to take you to expand the FSA or basically, in a sense, giving a tax break for a certain segment of the population? And then we’re cutting revenue for the government to provide services, let’s say, through Medicaid, to another segment of the population.
34:40
Because, you know, let’s be honest, and Medicaid recipients are not getting FSA’s because they can’t afford to, Maybe not even as an employer that offers it. So I think there’s a bit of health equity in the, in that loaded into that question.
34:55
I think it’s, we who are privileged to get to benefit from an FSA. Whereas, you know, the wider population doesn’t.
35:03
I also think it’s been a couple of years that Aetna and, you know, part of my role there was to sort of evaluate the value of different programs and services.
35:15
And if you think about what any of the payers do, and they often in ministry of the FSA’s on behalf of employer groups and the government and others, if they’re part of their charge is to basically set, determine what does good paid for and what doesn’t.
35:31
And they really do try to apply a lot of thoughtfulness and due diligence to this I can tell you this because I sat on on panels with many, many other doctors and other clinicians that were doing this.
35:44
And because the bottom line is that there’s not enough health care dollars to go around for everybody, and we want to make sure that health care dollars are being spent on things that work.
35:53
So, part of the challenge is, you know, when is the body of evidence good enough to show that?
35:58
This device, this app, this wearable, works in this patient population to do that. So, a lot of this is going to get down to the demonstration of value. I think, Beth, comments before about tying this back to, you know, outcome based value based payment is, is we’re everywhere we want to go, but but this is a journey.
36:19
And it’s going to take time to evolve and to catch up and have the, the, the, the basis of knowledge that says, This really, we really shouldn’t reimburses type of, of app, this type of thing because it adds value in this patient population in this particular instance.
36:39
Just a level set for the audience.
36:40
And most individuals who get FSA account, which are flexible spending account they’re under the age of 65 and they’re employed because you kind of can’t qualify if you are on Medicare and the people over the age of 65. Enroll in Medicare in the country.
36:56
So it does leave a very large subset of the population. About 120,000,130, 100, maybe, 120, 530 million people.
37:05
Without any sort of a vehicle like that.
37:09
There also, you know, the thing about FSA’s, are that the, that the person your employer owns and provides access to what you get in your FSA, so good information. Let’s talk a little bit more about data.
37:22
And if consumer generated data could integrate with provider system, this would be great way to solve, you know, start tracking patient reported outcome is, Is anyone doing this, that you guys are aware of?
37:38
I think that’s where Apple and Google want to get to, into, you know, with health care and the other systems that they’ve built up, to try to open those data pipelines.
37:49
I think they’ve given, in some sense, they’ve given up on the health care system, to open the data pipeline.
37:55
So they’re creating apps to pull in that data through their devices to the phones, and then that’s where they’re going to start modeling.
38:04
And it’s, you know, they already had the engineers to do the modeling, and then to go to the next step of actually building some machine learning and AI out of it.
38:13
And so I think it’ll come more from honestly, big tech then it well, it’ll come from startups innovating and big tech acquiring those startups and it will from the healthcare systems.
38:25
And we got part of this is going to be just driven method again. This gets back to, you know, what are people incented to do and how they are sending that back.
38:35
It really does get back to value based care.
38:38
You know, right now our, our, our delivery model for healthcare in the US, it’s very provider centric. It’s basically more, I have a problem. I go to a doctor. We try to solve a problem. But I, as a physician, I’m usually paid for the transaction as opposed to the outcome. Now, if you really want to get into outcome, you can see how valuable it would be to integrate clinical healthcare data with social determinants of health and other behavioral aspects.
39:09
and the things that really drive behavior that’s going to impact particularly chronic disease, and if we could bring them together and leverage them and tailor the treatments, too, that using that model, I think we’d be better off. But the problem is who is incented to collect all of those additional data sources because I’ve been in health care IT for 25 years. It is not easy to bring all these data sources together for many, many, many, many reasons.
39:39
So, again, you know, I absolutely agree that we’re seeing tech big tech, try to solve the problem by the, or try to enable solutions that make this more easy to do.
39:53
But, but the integration is going to require a redesign of our, of how we, how we finance, healthcare, and deliver.
40:04
Yeah. You bring up a really strong point. Go ahead, Yasmin.
40:08
Well, I was just going to add to what doctor Kelly was saying.
40:10
So I think you know one thing that I hope as we continue to move through this pandemic because we start to think about ways that you can leverage data to engage with patients and to sort of make clinical decisions without having a patient physically in front of you. And so I think that’s, we’ve seen a lot of, you know, expansion in terms of openness to telehealth. I think we’re still sort of tracking some of the trends as it relates to the adoption and the sustainability of those platforms being used over time. But that is one thing that I, you know, I hope to see, you know, there have been examples here. And there, there’s a ring, I believe it’s called, or where you can track sort of temperature for a patient and thinking about how that might be able to anticipate a Diagnosis of coven using data, like, in that way. And so examples like that, I hope that we continue to, as a healthcare industry, think about how that could be applied more broadly. How there are applications that can specifically target the needs of patient populations with chronic disease or vulnerable populations that don’t have the same level of access to care, You know, I hope that that spur some creativity as we think about how to sort of move through through the next months and years.
41:20
A whole nother topic right when you look at the Kobe Death, and you look at access, specifically in both tech, equity and health equity as, you know, kind of compared to, like, Telehealth and Telemedicine access to community.
41:34
Christine, did you want to join in?
41:36
Yes. As a startup on on the line, I would say that that’s exactly what we’ve done, haven’t built out a mobile health app. That that only measures Or collect beta patient generated data. Specifically, around the clinical aspect of what clinicians need, But also that social determinants of health aspect. And in my conversations, with payer systems, who are now trying to get ahead of, how do we do this stuff. A small startup has done that. Our next challenge is how do we integrate the data that were collected from the, patients, into the systems and have that data be incentivized and have a behavior change be incentivized and also using machine learning in that process. So, I’m excited for what we’re building, especially as it pertains to improve health outcomes of our underserved patients.
42:25
Yeah, that’s a great way for us to talk a little bit about, you know, people, right and compliant. Right. And, you know, are we seeing with wearables any sort of compliance with treatment and the use of wearable? Anyone? thing? anything out there?
42:42
I’m not sure if I’ve seen anything related to treatment, per se. I think one of the things I think about a lot is the reliability of the data. So, I love to share this story when I talk about sort of wearable devices with clients, is, I have both of my parents are very avid Fitbit users. They loved their Fitbit, but sometimes they, where each other’s Fitbit. So my dad will be walking around, and he has to fit bits on his arm to make sure that they hit the goal for the day. And I just think about that example a lot, because how are you able to use the data in a way that is going to be meaningful and help to impact behavior, change number one for a patient? But then also think about, how does that sort of align and integrate with the clinical data that you’re generating at your doctor’s office.
43:25
And so I think that’s a place where the challenges only are going to be exponential as we think about adherence to treatment and thinking about ways that you can start to track medications, things like that, that are going to be directly applicable to the decisions that you would want to make as it relates to …, Szent, healthcare.
43:43
We really need to, you know, sort of identify tools and strategies for communication that will help leverage these devices as tools, but not rely on these devices as a sole source of truth. When you think about how do you inform a patient’s care plan?
43:59
I love how, in the beginning, you talked about the gamification, and now you’re talking about your parents gamification, that, absolutely, game, gaming, the system as well. Yeah, go ahead doctor Maclean pointed. You know what you don’t think she said earlier.
44:15
I think well start to solve what she brought with her last comment, which is to use a video so Telehealth to know for vision impaired community. I can tell you, like I and many others, provisioning Paired Telehealth has been a huge help, because most places, including healthcare facilities, really are not accessible to people who can’t see low. And so, using video calls to interact with healthcare providers is, that was a huge help, and the Segway into something that she mentioned about the video as well, is that, that is a huge set of data. And it’s not just in house. So, if you wanna look at social determinants with, you know, my son goes to school remotely, the way we’re going to keep them on that. Because, you know, his ADHD and it’s actually been really beneficial for him to be able to be at home and sort of regulate his day instead of being in a classroom that’s just over stimulating.
45:08
That video right now is not being analyzed or used, but it’s, it’s a goldmine for trying to build algorithms based on, you have an outcome, right in school, it’s a grade.
45:18
If it’s a, if it’s a telehealth visit outcome, could be, you know, analyzing facial or sorry, the features could be analyzing facial expressions to look for depression or to look for something that could happen in the future. And … proactively intervene on that. So I think I think the use of telemedicine new use of video is huge and not And again, to tie into those other stakeholders in the retail space, this is one of the things in our second device is that we use a whole bunch of sensors to basically help people navigate and because they can’t, you know, like, for example, I’ll give you my personal example. I might go to Whole Foods. I have to use my phone constantly to zoom in and magnified find out you know, where’s the organic marshmallows. And whereas, you know, for everyone else, they see it so they don’t need to do that. And so, you know, our devices use a whole bunch of sensors.
46:06
It’ll tell me where that, where that product is. It’ll do text to speech to tell me the products there will recognize the face of the person who said who’s the expert marshmallows at that Whole Foods. And so if I have any questions, I’ll say, Hey, Ben is over there, you know, you can ask them about the specific thing, but much more so.
46:26
My dog’s name is Marshall. And I think that’s what I thought of marshmallows. But anyway, so I think that you set of sensor data, video, everything else in all of these realms is going to be huge. And healthcare realm. Telemedicine in the retail world, just in terms of devices we aware. And what it’s, it’s picking up as we go to retail spaces, into the clinical trials to see where people are going, what they’re doing, what they’re eating, let’s say to, to mesh that into that. I’d like to see results and also into the school space or into the churches or wherever we go and that influence us on the social side.
47:04
Well, that the expert of marshmallows in our houses my four year old so I totally get it. Let’s talk a little bit about digital therapeutics.
47:12
And what role the payer, particularly government payer play in ensuring access to prescription digital therapeutic.
47:20
Then if we get that question down, how do we think that act that challenges, confronting prescription digital therapeutics are different than other access challenges, that brother, like FDA cleared devices.
47:34
So why not?
47:36
Go ahead, I’m sorry, I’ll just, I’ll make a quick comment, but I’d love to hear from them in government and others on this.
47:44
I think that, you know, the way payers will look at this is the first is the one I see, does the digital therapeutic impact and outcome in a positive way. I mean, you’ve got to, you know, regardless, there needs to be a body of evidence that demonstrates that.
48:02
If it, and that’s the same bar, as for a non digital therapeutic renny therapy.
48:06
that, and, in my opinion, whether it’s a digital therapeutic or, or a traditional, therapeutic, the same, the framework should be used for evaluating it.
48:16
Now, I am sure that there are all sorts of societal barriers to access for digital therapeutics, for different groups, that I think we collectively have to really address in a much, much better way than we have. But in terms of Dremel frameworks, we should evaluate digital therapeutics on their value just like we would any other therapy.
48:43
Welcome to chime in on the juicy better digital therapeutics.
48:48
Well, I think, I would say there’s just a lot of exciting, you know, sort of new initiatives emerging as it relates to behavioral health, mental and behavioral health. I think that’s where we’ll see a lot of applications of the intersection of digital therapeutics and other traditional types of therapeutics sort of come to come to fruition. In, you know, we have our devices with us all the time. You have your phones with you, your smart speakers with you, and I’m really interested to kind of follow how we can use these devices in new ways to have access to information. And sort of thinking about how do you engage with patients in a way that meets them where they are. and that’s particularly important when it comes to mental and behavioral health. So, I think about something like, using voice as a digital biomarker to be able to track patients.
49:33
You know, the progression or perhaps a new diagnosis of something like depression or anxiety. There’s some work being done there. So, I think we’re going to see a lot of really exciting ways that we can use digital to kind of advance some of the work as it relates to mental and behavioral health diagnoses. And that’s a real challenge overall. But I think, especially has become, has come more to the forefront over the past year.
49:57
Great, anyone else want to chime in?
50:01
All right, let’s move on to another question. And let you know, we talked a little bit about patient patient use of wearable them They certainly heard Jasmine Parents story about, you know, wearing a Fitbit that I meet their their neighborhood goal, and, you know, are there any incentive that you guys can think of that give people?
50:20
And, like an incentive to continue to use a device on the long haul, or like to use it at all.
50:30
I think that’s a big issue.
50:33
Tidbits on data shows that there’s a huge drop off that he did after the first six months that someone buys a device.
50:40
And so, I think we’re, again, I clearly have biases that are coming out as Vitale beds.
50:46
But again, I think this is where big tech is really going to take the lead, because I don’t know about you, But do you notice how much?
50:53
Uh, notice the notifications, e-mails, the other things that are, that are, that I get? And I’m sure you get to keep me on Instagram. I mean, it’s it’s really quite crazy and uneven the ads that they show me. Right? So that targeting, and sort of gave me some of its gamification and some of this is just really understanding the user and what will keep me engaged. So, I think that’s where, that’s what’s going to be needed for a lot of this, to keep it sticky and, you know, so, in the technology world, right, the word sticky like it’s, it’s sort of built into the process, raid you mean. I’m sure it’s a startup, you also understand this as well because you are experiencing this, investors, Ray, you won’t get your next round of investors VC money. If your product’s not sticky, it’s just not going to, you’re not gonna be able to show that growth or that outcome or whatever it is that you have to do to get the next round of funding. It’s just easier to build that into the model.
51:52
So, that’s where I think big tech to drive it.
51:55
The other place, I think we’re big Tech Impact. We use, we use all sorts of wearable devices for a lot of our clinical trials that we wanted at the company I work for.
52:07
And, what we’ve actually found is, exactly, what Ben was mentioning that, you know, retention and continued use of these devices is a challenge.
52:17
The more we can passively collect information that doesn’t require people to actually do something, that’s going to be the real, the real, step change in us, being able to use these, as what I’ll call, monitoring devices in a good way, Not, not in a big way, but in a good way.
52:36
And I think that that is, is really where the opportunity is. Now, that’s going to take a little time to evolve.
52:41
Because, to really be able to use things like, Jasmine mentioned around voice, or tremor, or gait, which a lot of these sensors and smart phones can can, can do very, very well.
52:55
We need to correlate that with clinical disease so that, that, when we see this as a digital biomarker, we know that other clinical events happening.
53:04
There’s a whole body of very exciting work going on there, But, but it’s a journey, and we’re not there yet.
53:11
As we get to these passive collection of data, that doesn’t require me to do something five times a day or respond to an alert, we’re going to be on a much better place. So it’s coming. And there’s going to be an exciting time.
53:29
Oh, go ahead. Go ahead. one final comment there, and now we’re getting close to time. But I think this is also where it’s important to really think about how clinicians play a role. There’s data that shows that patients do really respect and value the opinions of their providers when it comes to the devices and things that they’re using outside of the hospital or the clinic. And so thinking about ways that you can use the time that a patient has with a provider to enhance that stickiness of the device, right? So if there’s a way that that is being integrated into the discussions that they’re having, perhaps that patient is more likely to use the device longer than the average, you know, whatever it is, four months or six months, and they typically would if they just walk into the store and buy it. And come home. So I think we want to really be thoughtful about how that integration is happening among the different stakeholders between patients, providers, social groups that I think Dan mentioned of interacting with churches, faith based institutions.
54:23
really thinking about how you start to create an ecosystem based around health and well illness. That includes clinicians’ but doesn’t only center at the hospital, or the or the clinic.
54:34
That’s huge. I mean, churches ready with the Barbara Study with, for heart disease and hypertension. High blood pressure, that, that was amazing. The results that were, that were shown, everything from cholesterol going down, diabetes, your sugar levels going down, blood pressure going down, and that’s always enabled by, you know, churches and Barbershops it because you, because that’s where the patient is.
54:59
And so I mean, I think that’s an example.
55:01
I didn’t want to one last question to you guys, all, just one quick round robin, here, because I think that kind of wraps up our day.
55:10
around, you know, how will the continued and increased the use of consumer wearable and help impact that digital divide, that we’ve kind of no talk circled around a little bit today.
55:24
Sure, I can.
55:27
So, I think my hope, I’m a very optimistic person, I really, my hope, is that we’re able to use these devices and the access overall to new types of technology within healthcare as a way to reduce bias, as a way to have more information about patients and their lived experiences. That will help improve clinical decision making and treatment planning for patients, rather than a way to sort of broaden that digital divide that we’re seeing. And so, if there is an opportunity to really keep the vulnerable populations as it relates to chronic diseases, or patients with lower socio economic status, really make sure that they are at the forefront of the design and innovation of these new platforms. I think it will benefit all all patients, and I think it will benefit the healthcare industry as a whole.
56:17
Any other thoughts before we wrap up?
56:20
That’s spot on. I can’t agree more.
56:23
I think that, I think, no …, right, user interface user experience.
56:27
I think that none and clothing, there’s this sort of two, or, for us by its concept. I really do think it has before us, by us, that the patient has to be designing, has to be involved in that innovation, evolving to iteration, involved in the child design, the trial follow up.
56:48
All of that has to be really done and centered by the people who are affected by the disease of interest.
56:56
I’ll jump in, and I’ll say, I agree with both of the panelists on that, I think that we have to think about this idea of collaboration, not only from the patient, but also the caregivers. And when we think about underserved patients in particular, the social workers, and the other clinical team and the providers. So, I think that’s a part of the narrative that needs to be bridge also, in addition to that patient voice.
57:23
Great.
57:24
Well, this has been the most exciting portion of my morning, and you’re getting this afternoon. I want to thank all of you for your insights on this very important topic.
57:32
I think this is all the time we have for today. I think we’re going to be talking about that for many more hours. So, I want to thank our panelists for joining us this afternoon.
57:40
I want to remind the audience to take time to complete the brief evaluation survey that you’re going to receive immediately after the broadcast, and as well as you’ll get it later on an e-mail.
57:50
And then, I wanted to give a couple of opportunities, the one we talked a little bit about telehealth equity today, and Health Tech for Medicaid, which is the organization I run. We have a very large telehealth equity campaign to make sure that more than a million individuals get access to telehealth services across the country, specifically in communities of color, which have been the hardest hit by …. And you can certainly go to our website and learn more about that.
58:16
But there are workgroups in which you and your staff and others can can be adkins can impact policy, and change the way we’re thinking about things, and, certainly, as we move into a new way of administration, and the alliance is going to be hosting an upcoming event on …
58:33
vaccine deployment, which, we all know it’s a top of mind conversation, that they hope to explore the most recent science on the vaccine candidate.
58:41
And how that may affect supply chain logistics. How industry stakeholders are preparing for vaccine deployment.
58:47
And the immediate steps that these stakeholders will take in the, in the first kind of 48 hours after emergency use authorization has been approved.
58:54
Additional details will be announced soon on the alliance website.
58:57
And so please sign up for that. Because that’s another area where we really need to make sure that we have all voices.
59:06
You know, really changing that curbing the divide and and changing that court the direction of the vaccine availability.
59:12
And the lights went to really hear from you, And they want you to fill out their audience survey. You can tell them what you’d like to see in 20 21 programming.
59:21
And a recording of this webinar and additional materials will be made available on the website.
59:27
Doctor Kelly doesn’t ban, Christine. Thank you very much for joining us.
59:33
And, I want to thank you all for attending tonight, you had Amica.
59:41
Thank you.