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FDA Insight: Episode 8 – Transcript

>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the deputy commissioner for Medical and Scientific Affairs here at the FDA. Thank you for joining us for another episode. This week, we'll be discussing digital health with our guest Bakul Patel, who is the director of Digital Health at the Center for Devices and Radiological Health, or CDRH, here at FDA.

Bakul, welcome to FDA Insight.

>> Bakul Patel: Thank you so much for having me on the show, Anand.

>> Anand Shah: So, let's set the stage. What is digital health?

>> Bakul Patel: Let's take a small step back. I think digital health – the way I think about digital health – is the convergence of technology, connectivity, and software that brings information and analytics in front of everybody, including patients and healthcare providers. So, as we start thinking about what are some applications? So, remote sort of care which has become prevalent in these days, ingestible sensors, AI, that's going to help or already helping, you know, spotting lesions on images.

I mean, all that technology that sort of drives better decision making in informing patients about how their health is progressing or informing doctors about how to take care of the patients in a much more efficient way. It's digital health. And that's kind of where we're heading in the future where we're taking care in a different level for patients in this country.

>> Anand Shah: Bakul, tell us a bit about FDA's new Digital Health Center of Excellence.

>> Bakul Patel: Absolutely, Anand. Part of our work in the last decade and a half that we've been working on various aspects of digital health, starting from mobile health to wireless technologies as planned evolution of the program at CDRH. And now, broader than CDRH, it's sort of affecting everything that FDA touches to some degree. And it's broader than CDRH and devices, but it's also – it also touches about healthcare and how we can enable that.

So, this Center of Excellence that we're in the process of launching is about making sure that FDA can lean forward and enable all stakeholders and its community internally. Absolutely, we will do that, but also create a platform for folks who are looking to have as a location where they can get the right information about FDA's role, how FDA is leaning forward, and looking to advance this field as we start to get excited about the potential of digital health sort of fostering innovation, which is really safe, responsible, and effective.

>> Anand Shah: So, what are the benefits of digital health tools for the average American?

>> Bakul Patel: So, these tools provide patients with wealth of easily accessible information. It provides patients with that connectivity with their provider that makes it easier for them to either get the results looked up on their on their phone, either making appointments easier. So, taking care of those things. And then more importantly, able to have patients manage their care as provided by the clinicians. So, especially chronic conditions that are really – really require maintenance and management. And having that close connection between the provider and the patient is really what sort of digital health tools sort of provide.

Access to telemedicine offers convenience. For example, it could allow a low-income patient to see a physician, you know, 30 miles away in other parts of America, where you have to travel that far. And now, with this technology is you can go visit a doctor right away. Those are the sort of benefits.

>> Anand Shah: You mentioned telemedicine, which is so important during COVID-19. How can the FDA ensure that all Americans have timely access to high quality, safe, and effective digital health products?

>> Bakul Patel: Let's start with telemedicine. Telemedicine is something that we have about eight years ago in a policy document mentioned that it's something that we want to see go further. Hence, for those type of products in a medical care setting are not something that we would have an oversight on or we would not be considering that as a medical device. So, we by that action itself, we allowed the space of telemedicine sort of grow and we wanted to make sure that that keeps on growing.

Let's then talk about the power of digital health tools that can bring to the table. For example, I will give a very easy example for a patient. Medication reminder is a tool that we would consider that will help patients in reminding taking medications on time, taking the right doses, et cetera. That's another policy we put out, which talks about – you know, that's something that we think benefits outweigh the risk. And hence, we would use our enforcement authorities to look at or not those products, but other products that are actually much more riskier and may actually impact patient decision making. So, that's sort of how we are sort of enabled and lean forward.

>> Anand Shah: So, there seemed to be some benefits of sharing data from a digital health product with healthcare providers. Do consumers need to be concerned for the safety of their privacy?

>> Bakul Patel: Look, electronic health records allow for sharing of patient information between healthcare providers. There's a need to have this interoperable information from one health system to another. Along with that, I think there's always a need to make sure that there is enough transparency in the system that patients understand how their data is used.

Of course, there's going to be caution in terms of how this infrastructure is set up in the hospitals, so that we are protecting the privacy of the patients. But get – data gathered via variables or that goes into electronic health records are shared by patients to providers do need to consider sort of the implications of health information per Personal Protection Act – Privacy Protection Act, which is HIPAA, which is actually regulated by the Office of Civil Rights in HHS.

You know, if you think about examples about – if you're downloading at the direction of a healthcare provider, an app that monitors your health data, then there are some portions of that would be covered by that law and needs to be protected. So, makers of these products need to consider those things infrastructure providers for those data should be considering those things. So, of course, we need to be more transparent and we need to make sure that it's interoperable so we can actually reap the benefits of this information.

>> Anand Shah: What digital health trends are you most excited about?

>> Bakul Patel: I will start off with, you know, a recent report I just read. I mean, the last few months, multiple market research reports have noted that a compounded – compounding annual growth rate for digital health market is greater than 28 percent, which is fascinating, first. We're also seeing a lot of technology providers and innovators building evidence in these medical devices, in these technologies, in the digital health products, which is driving adoption.

I'm also excited to see that players who are not traditionally medical device – in the medical device world or FDA-regulated world are now entering this space, which I believe will drive innovation and sort of bring lessons learned from other sectors and industry to this sector, and help us advance healthcare.

>> Anand Shah: Let's rewind a bit to telemedicine. Is this something that the FDA regulates?

>> Bakul Patel: I would say telemedicine is akin to videoconferencing and the call they are having. So, if we allow for that communication channels to be open, to allow for the patient centeredness and patient centered care to sort of be enabled, we have said in the past, telemedicine is not regulated. So, to be very frank, we compared that telemedicine platform with the provider to be akin to videoconferencing or teleconferencing.

So, we are not regulating those. But we want to make sure that that technology that takes care of the privacy of the patients as well as information that's shared is secure. And I think makers of this technology need to start thinking about those things.

>> Anand Shah: Bakul, I've spoken with quite a few folks during this pandemic about their feelings of loneliness and anxiety. How has the FDA responded to meet the needs for new mental health products?

>> Bakul Patel: That's a fantastic question, Anand. I totally would sort of hear the same thing when I'm talking to folks. And FDA in – during this pandemic, in this public health emergency, have sort of granted enforcement discretion, which means that we are allowing people to innovate in the space to solve some of those mental health problems. We did that action very early in the year. And most recently, we have granted market authorization to new products that sort of help with this space, actually addressing a lot more and addressing those populations that are actually vulnerable in this area. So, that's kind of what we are doing.

We feel digital therapy will in those ways either gaming – either through gaming or through other interactions with your smartphones or your smart computers, we'll provide tools to deal with this with this crisis we have at hand and also help us work through this public health emergency.

>> Anand Shah: Can you tell our listeners about the flexibilities that FDA has provided to expand access to digital therapeutics?

>> Bakul Patel: Absolutely. In response to COVID-19, just like mental health guidance that we put out, FDA has set forth a wide number of policies. I think we are in the range about 15 policies that we have increased flexibility, striking the balance between ensuring necessary regulatory oversight by – and meeting the immediate needs. The fundamental thread, if you may see, between all those policies is we want people to stay distance. We want people to sort of be – have access to those technologies, providers to have this access to those technologies so they can actually sort of take care and people can manage their conditions on a day-to-day basis.

FDA's steps to relax these requirements is more in line with sort of the needs of the public health emergency. I believe that the additional therapeutic devices in the future will provide more of these opportunities for people and more evidence will be generated as we start getting more experience with these products.

>> Anand Shah: Bakul, you've shared a lot of helpful info for our listeners. I really appreciate you joining us on FDA Insight, and we look forward to hearing more about innovations in digital health.

>> Bakul Patel: Thanks for having me, Anand. Technology changes so fast and I'm sure there are going to be more innovations to come. And for that, we all need to be prepared for the digital health revolution.

>> Anand Shah: Thanks again. In future episodes, we'll be discussing more topics including health fraud. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app such as Apple Podcasts, Google Play, and others. Thanks for listening.

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