There’s an App for That: How Should We Regulate Digital Health Technology?

Anand Shah: We should think of safety as a continuum rather than a binary yes or no. 

I. Glenn Cohen: I’m Glenn Cohen. I’m the Faculty Director of the Petrie-Flom Center, the James A. Attwood and Leslie Williams Professor of Law, and the Deputy Dean of Harvard Law School and I’m also your host. You’re listening to Petrie Dishes, the podcast of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. 

We’re taking you inside the exploding world of digital health, one technology at a time. Today it’s digital health apps. There are digital health apps that claim to detect melanomas, to treat children with attention deficit and hyperactivity disorder, to measure blood pressure, and improve vision. Simply put, the digital health revolution is here. But are we ready for it? 

Anand Shah: Consumers and patients alike want care delivered when and where it’s most convenient to them. And so translation is right now and at home. This is especially true during the pandemic, when there’s a convergence of home life and work life. And this past year, we’ve seen an acceleration in the use of remote approaches, for example, telehealth and remote clinical trial management.  

I. Glenn Cohen: That’s Anand Shah. 

Anand Shah: My name is Anand Shah. Up until recently, I was the Deputy Commissioner for Medical and Scientific Affairs at the U.S. Food and Drug Administration, where I was responsible for medical and scientific operations at the agency. Patients and regulators have acknowledged the significant advantages and we can expect these flexibilities to continue in some regard going forward. Digital health tech apps are critical to allow patients and consumers to receive health on demand and in the comfort of their own homes. And I think this is especially important for folks who live in rural locations across the country or are otherwise unable to make in-person visits, especially from a health disparity or equity perspective.  

I. Glenn Cohen: Shah speaks to the promise of digital health tools, not only in terms of convenience in reaching patients who wouldn’t have access to care otherwise, but also for addressing harder to treat conditions. 

Anand Shah: Digital health can help support decisions at both levels, especially in areas where quantification of outcomes is difficult. Think of mental health related conditions, for example, it can allow for improved real-time monitoring and opportunities to support patients through, for example, enhanced medication adherence and enriched data. Clinically the opportunities may be most pressing with chronic conditions that impact large populations like hypertension, diabetes, depression. 

I. Glenn Cohen: And digital health tools have the potential to be lifesaving by helping to track and monitor patient conditions as patient advocate and digital health app user Cynthia Chauhan can attest. 

Cynthia Chauhan: Yes, I use digital health apps. No, probably not as much as I should. The ones that I use is the heart tracker and it has an AFib tracker on it and that’s how I actually found out that I have atrial fibrillation, is through my app. 

I. Glenn Cohen: As Cynthia explains, her heart was feeling funny. So she decided to check her app. 

Cynthia Chauhan: My heart was feeling funny. It was like feeling erratic and I was just looking at the heart app and I saw the thing in it about AFib and I thought, oh, well, let me see if that tells me what’s going on. And all you do is you hit that app on your phone and then you hold your thumb on the phone and it gives you a reading and it came up AFib. So I thought, oh, I don’t think I have that.  

I. Glenn Cohen: Cynthia knows that the app alone didn’t find the issue. She sent the app’s information to her doctor with the hope that the doctor could then use that information to further investigate, diagnose, and treat the issue. This highlights the usefulness of combining these digital health apps with the care delivered as part of a traditional patient-doctor relationship. 

 Cynthia Chauhan: The first thing was me being aware of my body and being responsive to what my body was telling me. And my body was telling me ‘your heart ain’t working right.’ Then I remembered the heart app and did the AFib and found out, in fact, my body was telling me something really important. I sent it to my doctor and the same day he had me on Eliquis and had me set up for further study of the atrial fibrillation. So I think they can be a very good thing.  

I. Glenn Cohen: Cynthia’s story highlights the good side, but are there reasons we should be worried about digital health apps? Should patients be worried about things like privacy, accuracy, and the data these apps are collecting? 

Anand Shah: So consumers and patients need to be very clearly informed on what they’re getting. What the apps are intended to do, especially when used to inform health decisions. 

I. Glenn Cohen: Shah proposes an understanding of health app safety as on a spectrum. 

Anand Shah: Just as health apps exist on a spectrum, we should think of safety as a continuum rather than a binary yes or no. On one hand you have digital health apps that are non-regulated, non-interventional, and consumer-facing. Think of fitness trackers, for example. And on the other end, you have regulated prescription only apps like a digital therapeutic to actively manage chronic medical conditions. Some of these are standalone apps, while others require a connection to an external device, like an asthma inhaler. In many instances you’d need a qualified health professional actively working with the patient with a high degree of shared decision making around the appropriateness of a digital health app. 

I. Glenn Cohen: So, how do we decide which apps should be regulated by an entity like FDA and which are available to the public to consume as they wish without pre-market review? Let’s step back for a minute to discuss the regulation process.  

Anand Shah: So I think a little bit of history is worth discussing. Congress granted FDA the authority to regulate medical devices, you know, in the mid-seventies. And at the time most of these medical technologies were analog. 

I. Glenn Cohen: The FDA regulates medical devices and has done so for several decades. They determine the process for how devices are approved and make their way to market. But when most people think of devices, software is not what comes to mind. As Nic Terry, a Health Law Professor at Indiana University explains: 

Nic Terry: We think of FDA approval as going to devices, which are things that we can touch and see, and more mechanical things. And of course that’s nonsense. We have long had FDA requirements that software as a medical device, which is known by the acronym SaMD, can indeed be a medical device. 

I. Glenn Cohen: So FDA does treat some software, including apps, as medical devices within its regulatory scope, but what kind of software and how does FDA decide? 

Nic Terry: The question is just what software should be included? And some of those guidances were from the FDA to try and pull out of the complex regulatory approval system, the preapproval system. Things like fitness trackers and simple office scheduling software and so on. 

I. Glenn Cohen: There’s a difference between software that diagnoses atrial fibrillation and office scheduling software. The first has a medical purpose while the other just functions administratively. Software that we rely on for medical information should be treated differently from non-medical software that makes office functions easier. Shah adds some more detail, explaining how different software is from hardware. The FDA’s traditional regulatory process focused on hardware, making it difficult to use the same criteria to evaluate software. 

Anand Shah: Hardware based devices differ significantly from software-based devices in terms of their design, development life cycle, and also the risk benefit calculus. 

I. Glenn Cohen: What all this points to is the need for a different kind of system for regulating apps and other software-based health tools.  

Anand Shah: As innovators began to develop digital tools to reduce care fragmentation, promote personal wellness, and support the diagnosis and treatment of disease, the agency recognized the need to develop a regulatory framework that stays current and remains attuned to the unique consideration of digital tools like health apps.  

I. Glenn Cohen: What FDA ended up with is creating different categories of review based on the risk involved with different kinds of medical software, a sensible way of thinking about this, given the huge amount of medical software out there, and the negative effects that a one size fits all approach would have for regulatory review and for innovators.  

Anand Shah: And so to provide momentum for this digital transformation, FDA issued policy guidance in 2013 and then subsequently updated this in recent years. The FDA’s digital health innovation action plan was promising and established what we think of as risk-based policies explaining FDA’s regulatory approach. And so for example, the agency has focused its oversight on mobile medical applications, for example, those that are used to diagnose or treat patients, but less so on lower-risk, digital health products, especially those that are solely focused on promoting wellness. 

I. Glenn Cohen: Essentially, what FDA has done is to separate out general wellness digital apps. This approach was codified in The 21st Century Cures Act, which was signed into law on December 13th, 2016. It’s supposed to help get products to market faster in part by exempting low-risk devices, like certain kinds of general wellness software, from having to go through the typical FDA process.  

Nic Terry: The Cures Act took a big bite out of that. It said general wellness, low risk devices are out, a lot of mobile medical applications, off the shelf software used in medical devices, some storage things, and stuff like that. So there was a big chunk of stuff taken out. 

I. Glenn Cohen: Cynthia shares the intuition of reducing the need for intensive FDA review for low-risk devices. 

Cynthia Chauhan: If it’s something that’s just counting my steps or telling me to get, oh, that’s the other thing my eye watch does, it tells me I’ve been sitting too long, get up [laughs] but I allow that certainly helps my health. I don’t consider that a medical device. 

I. Glenn Cohen: The Cures Act also sets up a regulatory pathway for a new, low-to-moderate-risk devices, that still requires FDA approval, but expedites the process for getting the product to market. It is commonly referred to as the De Novo pathway. 

Nic Terry: Uh, the same time FDA recognized that there were more complex devices that were based around software that did need regulatory pre-approval but some of them were pretty low risk. And so increasingly, FDA has been using what’s called the De Novo pre-market review pathway, for those sort of low-to-moderate-risk devices, which are of a new type. And so that’s probably how things like the apple watch or the parts of the apple watch gets approved and so on. 

I. Glenn Cohen: Shah also explains there’s a new center at FDA dedicated exclusively to digital health. This exemplifies the efforts FDA is making to better understand and regulate a growing digital health field. 

Anand Shah: So this was a really exciting development last year, and it signaled FDA’s commitment to modernizing policies for digital health. The center serves as a front door for innovators, patient groups, and others to access the skill and expertise of the agency’s professional workforce in this space. And so hopefully we can expect a lot more from regulators on the near future especially around the use of digital health tech and drug development. Perhaps also clarity around expectations regarding use of digital health and study design, some comprehensive guidance on data standards and some other areas. 

I. Glenn Cohen: Shah’s mention of data standards brings back the omnipresent data privacy issues that are not unique to health apps, but instead pop up with all of our tech and devices. This is a concern over what data health apps are collecting and how they’re using or sharing this data. Particularly when you, as a consumer, are unaware. For example, Cynthia mentioned that she stopped using one of her health apps because of these concerns. 

Cynthia Chauhan: Well, the Fitbit, I mean, that information is important because one of the ways that I hold onto health is by being physically active. And that was an easy way to make sure I was being active. I made a choice based on data sharing, unapproved from my point of view, data sharing versus getting some information that’s useful to me. I also was using the Fitbit app [laugh] and you’ll think I’m really silly. Then I found out how much they were tracking me and I don’t want that. So I stopped using the Fitbit app. 

I. Glenn Cohen: Clearly, deciding whether to use an app involves more than perceived health benefit. It involves personal preferences when it comes to consumer privacy and level of comfort with data collection. It also involves safety. 

Anand Shah: We also have to consider not only whether the app itself is safe, but is it associated with any downstream consumer actions or behaviors that raise safety issues? There may be an instance where an app is recommending that a consumer or a patient take action or adjust their actions or maybe alter their behavior in some way. And so we need to think about not only the app in a silo, but also, what that app may be recommending that the patient or consumer does. 

I. Glenn Cohen: As Shah mentions, you have to think about apps not only in terms of their functions or stated purposes, but also their potential consequences for all different types of consumers or patients. But what if more generally health apps contribute to the same problem many apps seem to cause. A kind of distraction and alienation from reality, which could certainly be unhealthy.  

Cynthia Chauhan: It’s really important to be mindful of your own body and aware of your own body. And I don’t want to give that awareness away to an app. In fact, my body was telling me something really important that the watch could interpret better than I could interpret it. It’s a lifesaving thing because if you have AFib, your risk of stroke is extremely high. And if you get on the drug for that, then your risk of stroke goes way down. 

I. Glenn Cohen: So Cynthia and her app worked hand in hand. Cynthia was able to pick up on the signs that prompted her to open up her heart app and take that extra test. But what happens if patients become too over-reliant on their apps and pay less attention to their own sense of their health state? Digital health apps are just one tool we can use in healthcare. 

Cynthia Chauhan: I think you’re exactly right about the clues come from me. If I’m not aware of my body, then what does it matter what the app is saying? Am I even going to pay attention to the app? In other words, I don’t want to stop thinking about taking care of myself because the app is taking care of me. It has to be a kind of middle ground. 

I. Glenn Cohen: As Cynthia, Anand, and Nic have shared, digital health apps are a fast-growing frontier in the world of health and wellness. And with this new territory comes many questions. Are these apps safe for consumers to use? How should they be regulated? How do they fit into the existing world of medical devices? FDA and civil society groups continue to struggle with these questions, but it’s clear that we can expect continued growth of digital health apps. And it’s likely these apps will increasingly be incorporated into our daily lives. For now though, given the vast landscape which we’ll find in your app-store drugstore, much of the burden of decision falls on patients to decide when and whether to use these apps and how they might affect their daily behavior and their own awareness of their health. 

I. Glenn Cohen: If you liked what you heard today, check out our blog ‘Bill of Health’ and our upcoming events. You can find more information on both on our website, petrieflom.law.harvard.edu. And if you want, get in touch with us, you can email us at petrie-flom@law.harvard.edu. We’re also on Twitter and Facebook @petrieflom. 

Today’s show was written and produced by Chloe Reichel. Nicole Egidio is our audio engineer. T.H. Ponders is our audio producer. Melissa Eigen provided research support. We also want to thank Anand Shah, Nic Terry, and Cynthia Chauhan for talking with us for this episode. 

This podcast is created with support from the Gordon and Betty Moore Foundation and the Cammann Fund at Harvard University. 

I’m Glenn Cohen and this is Petrie Dishes. Thanks for listening.