September 14, 2020
By Christina Sandefur and Naomi Lopez

Fitbit, known for its popular digital activity trackers and smartwatches, received some long-awaited good news: The U.S. Food and Drug Administration (FDA) has finally given the company permission to release its most advanced features to date. This news comes after the company announced (and made available for pre-sale) its new Sense smartwatch. Prior to this announcement, the company had no idea when the watch would be fully functional (a few weeks ago, a spokesman expressed hope that Fitbit would receive clearance to unlock those features “before the holidays”). Thanks to bureaucratic delay, customers were left wondering whether their new device would be shipped without access to its most attractive features, like the built-in electrocardiogram (ECG), which is included alongside older features like tracking steps and pulse.

While this is good news for Fitbit, consumers who are unable to afford the Fitbit Sense’s $300+ price tag (or don’t need every bell and whistle included in a high-end watch) may be out of luck. That’s because every company and device requires separate FDA approval. In fact, any improvements or changes made by the same company to the same device requires new FDA approval.

In the age of COVID-19, it makes no sense to impose such obstacles. These smartwatch sensors don’t pose any sort of risk for users. The technology as a wearable isn’t even new. After all, competitors like Apple and Samsung have included ECGs in their smartwatches for years. Especially now, people need access to their own personal health data to help make more informed decision regarding their care.

But the FDA wields significant control over the sale of “digital health,” including wearable devices and even software and apps that provide people with information about a person’s health. The red tape is so complicated that the Federal Trade Commission (FTC) has an entire webpage devoted to helping companies figure out whether their mobile health apps are regulated by the FDA, the FTC, or, believe it or not, the Office of Civil Rights. Or maybe, it’s all of the above.

While the FDA does have a software precertification program to allow participating companies to “fast track” approval of their digital products, “fast” has a very different meaning within the FDA. After all, Fitbit is a member of the precertification program, but it had to wait years for the FDA to approve its blood-oxygen levels tracker.

The most important question is: Should the federal government outlaw people from accessing their own health information without first getting permission from Big Brother? Imagine if these arguments were still being made against home pregnancy tests. Today, 80% of women learn they are pregnant from a home pregnancy test, allowing them to more quickly seek and receive prenatal care. Yet when they were first proposed a half-century ago, regulators and some in the medical community worried that women couldn’t be trusted to properly use the tests—or to handle the news they deliver.

COVID-19 has sadly made it clear how high the stakes can be when it comes to accessing personal health information. In March, April, and May of this year—the height of the pandemic—deaths related to heart problems were about one-quarter higher than normal in the hardest-hit states. This was likely due to people avoiding the emergency room out of fear of contracting COVID-19. More recently, we are learning that the illness may leave otherwise healthy athletes—almost 15 percent—with myocarditis, or heart inflammation, that can cause a heart attack during vigorous activity. Wearable technologies like smartwatches provides users with useful personal health data—and being able to keep tabs on the state of one’s health through such devices can help a person decide if or when to seek outside medical care.

As we fight the COVID-19 outbreak, we should be doing everything we can to unshackle innovation in healthcare—especially when it comes to helping patients learn more about their own health. Instead, needless bureaucracy is stifling progress and causing companies to “avoid making their devices too health conscious.” In the midst of a global pandemic and the most innovative era of medical progress, we should demand a system that defaults to patient empowerment and encourages innovation, allowing people to improve their lives, rather than the current one that is keeping patients in the dark.

Christina Sandefur is the Executive Vice President and Naomi Lopez is the Director of Healthcare Policy at the Goldwater Institute.

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