Illustration: Jude Buffum
As more technology firms produce wearables, apps and connected medical devices that claim to help people live better or treat diseases, we need to draw a line between digital wellness and digital medicine. The entire health care industry needs to implement rigorous standards that can help differentiate between truly therapeutic products and the digital equivalent of snake oil.
Today, consumers and doctors are bombarded with claims. Apple says the Apple Watch can detect if the person wearing it is going into atrial fibrillation. Researchers believe they have developed an app that can tell if you are depressed simply by monitoring how you type and interact with the screen. Companies are pushing home versions of medical devices for detecting respiratory diseases in children, spotting chronic obstructive pulmonary disease, and testing urine that all claim to deliver clinical data.
In the United States, the Food and Drug Administration has clamped down on a few offending apps, such as several that purport to diagnose concussions. But there are plenty of devices that straddle the line between digital wellness and actual digital medicine.
Instead, those defining the distinction are pharmaceutical companies and the startups working with them to improve clinical trials. They’re creating benchmarks, writing best practices for device security, and urging doctors to adopt only technology that can clearly meet these standards. Maybe most important, they’re using devices that meet these standards in clinical trials to make the trials more inclusive and more efficient. With luck, their efforts will make digital medicine less hype-driven and more data-driven instead.
Andy Coravos, CEO of Elektra Labs, in Boston, has built a startup that tests qualities of today’s connected devices and creates what you can think of as an easy-to-understand label for each device that lets pharma companies know how well different products fare. The company’s benchmarks verify device claims such as whether a Fitbit’s accelerometer actually can measure 100 steps. The label also validates claims against a clinical goal—in other words, does that 100-step measurement actually mean anything?
The label indicates a device’s usability and security, and the device maker’s data-retention practices. Security and data retention are especially important: Coravos says that for the first time, pharma companies have to consider whether or not a medical device could be hacked, and where liability for that might lie.
Monarc Bionetworks, in Redwood City, Calif., is another startup trying to codify processes so that consumer devices can be used in clinical trials. Monarc is working with wearable-device companies, providers of electronic health records, and pharmaceutical companies to make sure the data that gets used is vetted according to clinical standards.
Bringing all of these efforts together is the Clinical Trials Transformation Initiative (CTTI), a public-private partnership cofounded by Duke University and the FDA. In February, it issued 17 recommendations to guide companies and clinicians in using smartphones and mobile tech to improve clinical-trial quality and efficiency.
The recommendations include establishing benchmarks like those used by Elektra Labs as well as how to introduce them in new tech practically. For example, CTTI recommends that a study ensure access to tech help for patients and clinicians, and suggests regular conversations about data use and storage.
This is a brave new world in which medicine can truly become personalized. But to give digital medicine a healthy future, we have to ensure that what’s on the market is actually therapeutic and not just electronics wrapped in promises.
This article appears in the September 2019 print issue as “Digital Snake Oil.”