The Ropes & Gray Decoding Digital Health podcast series discusses the digital health industry and related legal, business and regulatory issues. On this episode, Digital Health Initiative co-lead and IP transactions partner, Megan Baca, is joined by Verily Life Sciences Lead Product Counsel, John Vaughan, to continue their discussion on Verily's innovative partnerships in digital health, the challenges Verily has faced as well as the rewarding solutions that Verily and its partnerships have created.

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Transcript:

Megan Baca: Welcome back to Decoding Digital Health, a Ropes & Gray podcast series focused on legal, business and regulatory issues impacting the digital health space. I am Megan Baca, co-head of Ropes & Gray's IP transactions and licensing group, and co-head of the firm's digital health group. I have a background in computer science, and I practice law in the heart of Silicon Valley, so I represent pharmaceutical, biotech, data, software, artificial intelligence, hardware, and technology companies and their investors on complex IP and technology licenses, collaborations, and other transactions. In this second part of my discussion with John Vaughan, lead product counsel at Verily Life Sciences, we'll continue our discussion on Verily's innovative partnerships in digital health, the challenges Verily has faced as well as the rewarding solutions that Verily and its partnerships have created.

When we left off, John, you were describing the speed with which your technology has been able to develop solutions and products for end users. Part of that is based on the quick iterations of products that you can do, like you said, and technology that you can't necessarily do in the pharma space in and of itself. So, in that context, it brings to mind the concept of privacy, and in that context of speed, how you go about protecting users' expectations of privacy in a world where things are moving so quickly and iterating so quickly-and I'm sure it's not black and white in all cases. Can you describe any product decisions that Verily has had to make that require balancing and decide how to handle privacy and build that into the rapid pace of development and in that rapid innovation against the user's privacy, and also the steps that you take to assess ration?

John Vaughan: One thing that we do really well is privacy by design-so when we are developing a product in any of the spaces that we're working in, we do it by design. We're thinking about the privacy principles, including consent, minimization and transparency, and major legal frameworks that are going to affect the way that we design a product. So, whether that's something like CPRA, GDPR, or the various privacy laws around the various states around the world, we're thinking about that as we're building these products. The second thing that we think about, which is more of an Alphabet or a Google philosophy here, is that we respect the user. And so, that end user needs to be comfortable that, when she is giving us information, we are being very careful with that information, that we're taking the minimum information we need in order to get that job done and nothing more. I think those overall arching principles are helpful.

One of the things that you'll find when you're developing products, particularly devices, is that we may find that a device will give us insights about a disease state. For instance, if you're developing a pathology tool, if you find out that you could diagnose new diseases earlier, it's something to be thinking about in terms of privacy. If someone has given consent, but we think that we might be able to find earlier indications of a significant disease, we need to think carefully about what principles to engage in. So if we found out that AI was able to diagnose pathology earlier, you might need to re-consent patients in a clinical trial to make sure that they're aware that you might be able to give them more information, but that may not be what they signed on for. And so just thinking about what that user's expectation for any of our products is the fundamental way that we do privacy by design. We're never going to avoid every problem, because there are always going to be use cases that you don't think about early on in the life cycle of a productbut taking those privacy by design principles and putting them to work in each product that we're doing helps us minimize that. And not only does that minimize the disruption to your program, but it also minimizes the possibility that you will get more information that the user did not expect you would have.

Megan Baca: You mentioned how your technology can lead to insights about disease states and how we have to use privacy by design to ensure we're using that information correctly. In our last webinar, we spoke about the power of harnessing technology to develop a whole new set of tools for prevention rather than necessarily cure; so for example, using algorithms, like you mentioned, to identify signs for someone who might be getting sick or might be likely to get sick-and it seems like that's a major tenet at Verily, which is to turn on its head the traditional health care approaches in implementing these personalized medicine solutions. For example, instead of thinking about things as disease care, you're thinking about it as health care generally. And instead of treatment, you're thinking about wellness. Is that fair to say in terms of how Verily is thinking about flipping the script on health care?

John Vaughan: That is right, and it's changing our point of view backwards from the individual to societal or public health level outcomes. We talk a lot about machine learning and algorithms, and how algorithms can screen for conditions that previously required a clinician's evaluation, and so some folks worry or perceive, therefore, that algorithms would take the place of clinicians or that the role of clinicians would somehow be diminished. We see things differently-machine learning algorithms allow for consistency and consistent screening, and that, we hope, will make diagnosis more accessible and lower the cost of screening for serious diseases. What we're trying to make more folks aware of is that eventually that will mean that people are screened earlier. And so for diseases that proliferate, the result will often be an improvement in patient outcomes, both for the patient but also for society, that more people will be diagnosed earlier, receive better treatments, which is better for more people in terms of lives saved and quality of life preserved, but also for reducing overall costs to the health care system. What this means is that the type of intervention that clinicians may offer will also change, and so that will also then change our aperture for where other processes or diagnostics are ripe for innovation-so we view that as overall beneficial for society.

Right now, one of the things that we're doing, too, is that we're working on a COVID preventional and viral variant prevention project at the societal level. And so we're working with a number of stakeholders to spark a common national wastewater monitoring program that would establish sensitive methods (which are unified across all sites) to help prepare for the next pandemic. Our vision is to make wastewater a free public health tool that would provide open-source, actionable, and real-time data to a wide variety of national stakeholders to rapidly track BA.1 (which is the Omicron variant), BA.2, influenza, or RSV with established capability to add new variants and other pathogens tested in wastewater. It's a great way of showing our scale as an organization, because early in the COVID pandemic, we started with individual testing, and now we're trying to figure out, on a county, city, national or international scale, if we could help localities learn about variants of concern or other viruses when they first appear in the watershed weeks ahead of when you'd actually see a wave of patients going into a hospital.

Megan Baca: That was totally fascinating and really exciting. One of the things that seems to be a hallmark is this really creative process improvement, and improving health and health care, but also availability to places and people that didn't have it before-and I think a big part of that is accessibility. It's exciting for me to think about the possibility of more direct-to-consumer products and wearables that could become the primary or a primary method of communication with the health care system or the health care providers. So, is Verily thinking about this? And what kind of hurdles do you see in the system to making this kind of accessible technology for people to interact with their health care system and providers?

John Vaughan: It's such a great question, and it's such an interesting space for our industry. You see everything from Fitbit to Apple Watch-you see a lot of different wearables where we now have the capability to obtain a lot of different digital biomarkers. And I think then the question is, as a consumer, because most of these are consumer products, "What do you do with those insights?" That is more the space Verily is in, which is that we have a product called Study Watch, which can be used in clinical studies, or you can obtain digital biomarker data that would give a pharmaceutical manufacturer a more holistic set of data per patient about other digital biomarkers that are relevant to their analysis. For instance, if you were giving a patient a new drug to treat a heart condition, understanding mobility, understanding pulse rate, understanding whether there are any excursions is really helpful data for a manufacturer while they're conducting a clinical trial to see if there's anything from ways that they could change treatment to the early stage signals, so those are useful tools for a customer. And that area's interesting because you can consent those patients to obtain those exact digital biomarkers through the informed consent process, because there's an IRB usually looking at clinical trials. It's a very interesting way to learn these new things.

Megan Baca: For digital health companies like Verily, it's clear that companies have to continually think about reinventing and iterating not only on their products, but their own focus, their own priorities, their own purpose. So, what considerations should be at top of mind when thinking about making changes to strategic priorities from one service to another through acquisition, partnership, or even shutting down projects? What sorts of things come to mind for companies like Verily when evaluating really, "Where is the next big thing? Where should our resources be best deployed?" and all that thought process?

John Vaughan: I think the most important consideration is to keep your promises to the consumers or the patients who are using your devices. A lot of times, in life sciences or in tech, because there are always new things and interesting things, we're excited by newness or excited by focusing on new products, but understand that there are patients who rely on the products that you're putting out on the market right now, whether that is a digital health product, whether it is a drug that's subject to shortage, or whether it's a medical device that might not be profitable but is life essential. All of those things require you to keep faith with the customers who have used your product or the patients who've used your product for years. So, number one is you always need to be thinking about those patients, keeping your promises, and making sure that when something is made better that you're keeping those early adopter patients in mind.

The one thing that I need to tell you is that I came from life sciences. And in the 18 months that I've been here, I have learned a lot, and I have been humbled about all the things that you need to understand from a technology point of view about the things you need to do to make sure that you're in compliance with laws and regulations with respect to technology. So, it's not an either/or-it's thinking about it holistically. And smaller companies tend not to do that. I also think you need to think long term about adoption of a product, like I said, keeping your promises to your patients, making sure that you don't pull the rug out from anybody who comes to rely on your product. And also think long term about "Where does this product, service, or software fit in the health care ecosystem now? Where will it be five years from now and ten years from now?" I think those are probably fundamental things to keep in mind as you're doing diligence or thinking about new partnerships or new products.

Megan Baca: I am excited to see where Verily goes in the coming years, for sure. So, any closing thoughts or memorable quotes, headlines, posts, news items you've heard recently that have you thinking about or excited about new aspects of digital health?

John Vaughan: I joined this company because I really believe that this is where the future of health care is going to be, and so I think for the rest of my career, it's going to become increasingly clear that precision medicine, health tech, or digital medicine will just become medicine. So, I'm excited to see how these products become integrated, and I'm excited to be a part of it. And I'm excited to be working for a company that thinks carefully about users and privacy. Megan, when we spoke back in March, I still think that it's interesting that with respect to these two disciplines in technology, we always talk about failing fast and coming to the next iteration. And then, in health care, there is a conservatism because you're dealing with patients, diagnoses, and their lives, and so, there's a reflection of the Hippocratic Oath, which is, "First, do no harm." Our job at Verily is to reconcile those two perspectives in a way that enhances both personal and public health.

Megan Baca: I think that rounds out the conversation. John, thank you so much for joining me-I have learned a lot. And to our listeners, please stay tuned for additional podcasts in the series-we'll be discussing further trends and hot topics in digital health, so definitely tune in. On upcoming podcasts that we have planned, we'll be talking about developments related to digital health in clinical trials, artificial intelligence, machine learning, and other subjects.

Thank you so much for listening today. We appreciate you tuning in to our Decoding Digital Health podcast series. If we can help you navigate any of the topics we've been discussing, please don't hesitate to get in touch with us. For more information about our practice or other topics of interest in the digital health space, and to sign up for our mailing list with access to alerts and updates around notable developments as well as invitations to digital health-focused events, please visit ropesgray.com/digitalhealth. You can also subscribe to this series wherever you regularly listen to podcasts, including on Apple, Google and Spotify. Thanks again for listening.

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