Navigating The Digital Health Maze: A New Compass with Jennifer Goldsack, CEO at the Digital Medicine Society (DiMe) and Kimberly McManus, Deputy CTO & Deputy Chief AI Officer at U.S. Department of Veterans Affairs

[00:00:02] Hey everyone, welcome back to the Outcomes Rocket. So excited you could join us today because I've got two amazing guests. One you already know, another amazing guest that you haven't met yet, but you'll be impressed. I'm so excited to have Jen Goldsack with us. She founded and serves as the CEO of the Digital Medicine Society, also known as DIME. It's a nonprofit organization dedicated to advancing digital medicine to optimize human health.

[00:00:32] You guys have heard her voice before, but we also have Kimberly McManus with us. She's a Digital Health and AI Innovator, currently Deputy Chief AI Officer at the Department of Veteran Affairs and Health AI Startup Founder. I'm excited to have both of them here to talk about, of course, AI, but also digital health and how we can do our best to innovate in a way that's sustainable, safe, and benefits everyone, especially the patients. So Jen, Kim,

[00:01:02] thanks so much for joining us. Really great to be here, Saul. Thanks for having us. Absolutely. Thanks for having us. Of course. And so look, to kick things off, I want to really for the folks that haven't had a chance to listen to Jen before, but also for those of you that haven't met Kimberly, let's kick it off with just an introduction around what you guys do, what you do, and why healthcare?

[00:01:23] So those are some really big questions. I think healthcare, and you can tell from my accent that I grew up with a pretty different healthcare system where healthcare is something that I've always considered to be a right, which I took for granted because absent good health, you really struggle to live a full life and participate in today's society because it's simply not optimized for people who are struggling with their health.

[00:01:51] And yet we still have a sick care system, not a healthcare system. So there's an enormous gap between the care that we're able to provide to people and a limited range of people too, and how hard it is for them to actually live a full and fulfilling life, which in my opinion, every single person deserves.

[00:02:10] And so why I do what I do, which is founded and now incredibly proud to be the helm alongside wonderful colleagues at the Digital Medicine Society is, while I don't think that the digitization of healthcare is a silver bullet, I do think that we have had pressing and persistent challenges in our industry around access, around equity, around frankly, subpar outcomes, diagnoses that are given without any options that we can provide about care people can resist sustainability and cost for individuals and

[00:02:41] And I think that the digitalization of the world. And I think that the digitalization of the world can be in the world. And I think we have this powerful new set of tools in the toolbox. And if we don't, as a industry and as a society, get really focused on how we can leverage these new tools in pursuit of actually moving to a healthcare system, I don't know what a sustainable future looks like. Yeah, amen to that, Jen. Couldn't agree with you more. Glad you're doing what you're doing. And Kimberly? Yeah, I think I ended up at a similar place, but started from a very different place.

[00:03:08] My initial interest was as a scientist. So I did a PhD in machine learning on genomic data in the early 2010s. This was a really exciting time for the field. The human genome had just been sequenced. We had all of this data, and we were going to solve all of healthcare. And so we did do a lot of research, and we developed a lot of models, etc., that we posted in papers.

[00:03:31] From that, I saw the real potential value to use new technology, machine learning, etc., to really improve human health and lives. So after grad school, I jumped off into industry and into government to really figure out, exploring from a variety of different angles, how we can best use data and use machine learning to improve healthcare outcomes.

[00:03:51] Thank you guys so much. And Kimberly, thank you. The work that you do is important. And without a doubt, AI, machine learning, it's all come so far. Like there's so many things that we could do now that we couldn't do even a year ago. So where I want to go with this is really focus on the partnership that you guys have. And I know you guys also have some news, some things that you guys have recently launched as early as health. So let's talk about that.

[00:04:20] Happy to. And anytime I get to work in any capacity with Kimberly is really a privilege. So Dime had some really important partnerships with VA working to develop things like a playbook for digital medicine implementation that is now very widespread. But in this case, Kimberly comes to the table for a really exciting new initiative we have at Dime, the Dime Seal, and serves on our governance committee.

[00:04:48] And the purpose of the Dime Seal, or the problem that we're trying to solve for with this new initiative, is to take a model that we know really well. Think consumer reports. Only in this case, we've optimized the Dime Seal for digital health software products. And first of all, it's actually sized that market for a second. There's over 300,000 different health and wellness apps in the Google Play Store and Apple's App Store.

[00:05:17] Then on top of that, there's all of these software products that are going through things like FDA clearance as actual medical devices as software products. And then there's all of these new technologies that we're looking at to help improve workflows and different sort of operational pieces of the healthcare system that don't have a medical claim.

[00:05:36] And we all know that the end users and the buyers of these technologies don't have enough time to sift through a market that big to make great decisions that minimize the risk of taking a tool that might not actually have the evidence to support the claim it's making,

[00:05:52] or might not have the appropriate privacy and security safeguards so it doesn't tank the system and cause harm to patients and to the integrity of the organization itself that may not be optimized for a clinical workflow or for use by every single patient that it could potentially serve.

[00:06:10] So what we set out to do with the dime seal is can we create a framework and then a system of recognition, just like consumer reports, that makes it easier for the end user to identify high quality, trustworthy digital health software products. We're not telling them it's perfect for their needs, but we're saying if you look at this short list of products that align with the problem you're trying to solve for, you're not wasting your time. And we've really de-risked this decision for you.

[00:06:37] And the really nice thing about it is it also allows those developers who are building great tools in a very crowded and competitive market to differentiate themselves. And the great thing about having Kimberly on the governance committee is, Kimberly, your expertise, both as a scientist and a technical expert, helps us speak to, are we getting this right from a performance perspective? But you so deeply understand the needs of the healthcare systems as well.

[00:07:03] Yeah, I've been really lucky to work with Jen and the amazing dime team. I think I've worn many different hats in the healthcare industry, seen many different parts from a mid-sized consumer health company to large integrated health system to very small health tech startup. And in all cases, we see this challenge that I think the dime seal is really starting to help with and a gap we can fill, which is what is a good quality product? How can you identify that?

[00:07:32] If you're a large health system, you get pitched by a thousand different products every few days and you don't time to sift through every single one of them. And so what are the signals that you can use of things that have been pre-vetted? Now, this really might add value. This really lives up to these X things that it says that it does. I think really will save time and improve the quality of products that health systems integrate. And then from a startup standpoint, on how do you really differentiate yourself between others?

[00:08:01] I think everyone has a lot of sales and marketing, but having clear differentiators to know that when you're a high quality startup, that you can really signal that in a way that people would recognize and will also be very helpful. Yeah, that's really, that's really great. And really just having something like this is a big need. There's organizations trying to do something to help in this respect, but it's nice to hear about this initiative.

[00:08:29] And so is it mainly the health systems that you're looking to help with this DimeSeal? Or is it also consumer-facing apps and helping the consumer understand that it's a validated product? It's the full gamut, Saul. And that was actually really important to us. And the governance committee pushed us to be as inclusive as possible.

[00:08:49] And so the DimeSeal will cover any digital health software product, whether that is one that is your purchaser would be the healthcare system, or maybe it's a health and wellness program within a large payer or even an employer. Or it may be a product that is being sold directly to the patient itself.

[00:09:07] But what was really fantastic, and we tested this hypothesis from the start, which is regardless of what kind of product you are, if we think about the tenets of what trustworthiness and what quality means in an industry that's supposed to care for people, we were actually able to set benchmarks that transcend all of those different sort of end users, buyers, and product types. Do you have evidence to support the claim that you're making? That claim might be a clinical claim.

[00:09:36] That claim might be a performance claim. Like, we can reduce your sort of provider time spent in administration by 20%. Great. Do you have evidence to support that before you go out and you pitch that? Or if you are doing a sort of health and wellness app for not even a patient, but someone who might have a history of kidney issues in their family and they want to monitor their potassium and their sodium,

[00:10:02] do you have evidence that the numbers that you're sharing are actually correct when someone says, yes, I went and got my lunch from Panera today? These are the sorts of things that we ought to be able to expect. The same thing for privacy and security. We're not going to be a nanny state and tell you how you can use the data. But if your language, if it's patient-facing, isn't written at an eight-grade reading level so anyone using your product can understand how the data is being used and decide if they want to use the product, not acceptable.

[00:10:29] If your security protocols are likely to cause a breach in data, which would bring harm to the patient and also to the system at great cost, expense, and perhaps a sort of cascading effect of impact on patient care, that's not acceptable regardless of product type.

[00:10:46] From a usability perspective, whether it's a clinical product that we expect to actually dock into the EHR instead of being another portal that a provider actually has to open, or whether it's a patient-facing app, and have we actually made sure that the security protocols aren't so aggressive that they've locked down voice enablement so that we're excluding a particular class of users?

[00:11:09] I'm really proud that we were able to bring together a single standard and practice that allows us to say, yes, regardless of how we're using this digital health software product, it is of a baseline quality that's acceptable, and we can trust it. Thanks for that, Jen. And as we look at sort of the industry overall, you guys want to comment on acceptance of the dime seal?

[00:11:38] I can start. And then, Kimberly, I'm curious about what you've heard from the community in terms of just the gravity of the pain points that we're trying to solve for. So we've definitely had large health systems, even payer organizations say to us, this is tremendous. We are going to start relying on this dime seal as the initial sorting hat, because you always need a Harry Potter reference in these moments, to help us decide what we even consider.

[00:12:06] And I'll give you actually a data point that I think is really interesting, which is we did a listening session with C-suite officers from healthcare systems across all 50 states in the US. Different settings, different payer mixes, different profit margins, so on and so forth. And here's some back of the envelope numbers. Because on average, the systems were saying it takes them between about 75 and 150 hours to actually fully evaluate a digital health software product.

[00:12:33] And they're not even sure that they have the in-house expertise. This is not their core business. They are clinical experts. They provide healthcare. They aren't technical experts. They're not even sure that they're in-house, but they're not-of-the-art business. Especially the small and medium-sized hospitals that don't have a chief digital officer, for example. It's the CEO making these decisions off the side of their desk on a Thursday afternoon. And right now, most systems are making about 20 strategic software purchases that are enterprise level every year. So let's actually start to do the math.

[00:13:01] Even if we assume they don't look at more than one product, we know, to Kimberly's point, they get pitched by thousands. And even if we think that they're only looking at 20, let's then start to multiply that by 6,000 health systems. That's an enormous amount of time and resources that we just don't have as an industry. And that feedback has been really powerful. Kimberly, I'm curious for your thoughts and experience of just the inefficiencies of making good decisions. Yeah.

[00:13:29] I remember when Jen first pitched this idea to me. And it was one of those kind of light bulb moments where you're like, this is the thing that's missing. And definitely, I think all of the different dimensions that Jen mentioned that the dime seal covers, that covers a lot of different types of expertise. And I think the 75 to 150 hours sounds about right. And we can't, there's only very few products that we could do that with.

[00:13:55] And so having a way to sort, to identify that these are the products that we think pass this kind of minimum bar that should be looked at, I think will save us many hundreds of hours of time and not going down kind of roads that are unnecessary. And also allowing us to work within our own expertise to identify which products might be the most high quality. So I think it'll be an exciting game changer and excited for a continued awareness of it.

[00:14:25] Yeah, for sure. Oh, go for it, Jen. Yeah, so if I could just go on to that, one of the things we really want to applaud Kimberly and the rest of the governance committee for is pushing us in approach as well, because there are different ways that you can implement a program like this. We obviously did an awful lot of research. We triangulated across different government regulations, industry standards to make sure that we weren't a net new burden for the industry. But actually, when we look at security, we stand on the shoulders of high trust and SOC 1, too.

[00:14:55] When we look at evidence, if you're making a clinical claim, you test out of that section. If you have a 510K clearance from FDA, if you have a high trust security certification, you test out of the security section. Like, you've done the work. And if you don't and you're younger, then we give you an opportunity to showcase that you're meeting the bar. And that was something I really enjoy. The other piece is we don't throw people out who don't meet the threshold of the seal on the first go.

[00:15:22] And this is really something that Kimberly and the rest of the governance committee helped us with. So we've actually staffed ourselves at Dime to be able to do one-on-one work with the developer and go back to them and say, for example, oh, you have a patient-facing app and your privacy policy isn't meeting an eighth grade reading level. And we have a dialogue with them. They say, well, you know, our attorneys say we have to because we're a medical product. And then we take them to the piece in the FDA guidance that says that's not the case and you can update your privacy policy.

[00:15:50] And we actually have companies that are currently making updates to things like their privacy policies or their security settings so that we can actually use voice enablement. They're making their products better. So it's not just the differentiation. We are going to be that rising tide that lifts all boats. And Kimberly, you'll love this, which is we're even starting to see a few code sets come in that we have concerns about. And people are going back and actually adjusting some of the codes so that if there's an update, it doesn't break things on the system end.

[00:16:18] I'm curious to get your thoughts about that because I think it's a lovely proof point, if you like. Yeah, that's amazing. I'm excited how in-depth that's getting. And I do think from the digital health founder side, also just having that, as you said, build on top of high trust and ISO and those types of things. But having that kind of pathway of these are what the expectations are, I think a lot of digital health founders, they may not be experts in what a privacy policy should look like. So they do just follow what their lawyers say.

[00:16:43] But having what we think the standards be in digital health space, I think is also incredibly helpful. Well, that's very exciting, guys, and certainly great to hear. And one of the things that I want to point out is really the partnership that you guys have. So the importance of these partnerships in order to make initiatives like the Dime Seal possible. Talk to us about that. And how would you encourage our listeners and viewers to take on partnerships like this?

[00:17:13] I would not have been confident taking something like the Dime Seal to market unless we'd had the true leaders at the industry at the table looking over our shoulder and saying, yes, the way that you probe the scientific literature, the way that you've done a sweep of things like the industry standards, the regulations, the way that you have done engagement of end users and developers to make sure that we are appropriately setting the bar.

[00:17:41] And the way that you even talk about this is not we don't have a list of people who didn't get the Dime Seal. We have a list of those products that did. And there's a catalog and we can drive the end user there. I think that for me, the partnership with Kimberley that I've enjoyed so much is, Kimberley, your expertise. As you've said, you've seen the digitization of healthcare from just about every seat at the table.

[00:18:06] So you're able to share with us and push us on things like, have you actually thought about the needs of the stakeholder? Have you thought about the burden in this example? How are you dealing with X, Y, and Z? And that's the responsibility, I think, that we take very seriously at Dime as an organization, which is to bring the best of the best to the table and frankly, check our work and drive us to deliver not just the easiest resource,

[00:18:35] but the highest quality, most impactful resource that's actually going to make a difference. And some of the examples that we've talked about today about changes that the developers are making, I think really, really proved that out. So this is great, actually, because this is a question I've always wanted to ask you, Kimberley, which is you're so busy and you have this wealth of experience, and you're always so good at coming to the table when we ask for your help. I'm curious as to the value you get that makes it worth your time.

[00:19:02] Well, Jen, I think you're a master connector of all the good parts of the healthcare industry. Yeah, no, I think things like the Dime Steel really drive everything forward for all types of stakeholders that have been brought to the table. And so I'm always excited to be part of things that really involve driving the industry forward and involve taking rather diverse groups of people that all have a different stake in this role and figuring out how to make progress. So it's been really exciting for me.

[00:19:31] So guys, I just want to say thank you for the work that you're doing with the Dime Seal. It's going to make a difference for a lot of health systems and people in healthcare as patients. What closing thought would you leave us with? And where can people find out more? I can share where people can find out more. And then Kimberly has left us at Dime with so many good thoughts to take forward. I'm going to leave the closing thought to her. So for folks who are interested, all of the information about the Dime Seal is on our website.

[00:20:01] So I'll make sure you get that so you can pop that into the show notes. So whether you're a developer interested in what the evaluation rubric looks like and actually coming through and getting your product assessed for the Dime Seal, that's all there. And the same thing, and equally importantly, is for the buyers, the end users of these digital health software products, there's a really nice interactive searchable catalog of products that have been awarded the Dime Seal, even just in the last few weeks since we've launched,

[00:20:28] and that can really become that first port of call, that first bookmark you look at before making some kind of investment. Not even the purchase decision, but even your time to contemplate where the solution might meet your needs. That's all open access through the Dime website. So I love it. Thanks for that resource, Jen. And Kimberly, you're going to give us the closing thought here. Wow. Now is a really exciting time to get involved in the digital health space.

[00:20:55] I think whether you're a developer interested in healthcare or a provider interested in getting more involved with digital health, I would just recommend that anyone interested. It's a really fast-growing, I think, impactful area to get involved in. Love it. Great call there. And folks, make sure you get involved. And in the show notes, we'll share where you can do that. So make sure you take a look at that, not only to check out the Dime Seal, but also to find out ways to engage with Kimberly, with Jen, and with their entire team

[00:21:24] on how you two can make a difference in making healthcare more accessible through technology that is vetted and not just thrown out there. So Jen, Kimberly, thank you both for your time today. This was a lot of fun. Oh, it was great. Thanks for having us. Yeah, thank you.