A Digital Health Revolution Is Happening Now, but the FDA Can’t Keep Up

Innovation moves fast — much faster than government agencies can enact new regulations, provide guidance, or approve healthcare devices. Pexels

Consumer demand has never been higher for information and data about our own bodies — and businesses are not afraid to step into this arena. Thanks to entrepreneurial and technological advances — from wearables counting our steps to smart patch thermometers tracking our children’s fevers — consumers are gaining unprecedented access to health information and making healthcare decisions without even setting foot in a doctor’s office.

Innovation moves fast — much faster than government agencies can enact new regulations, provide guidance, or approve healthcare devices. The Food and Drug Administration is realizing this and is thankfully trying to do something about it.

The FDA has begun a trial of its new Digital Health Software Precertification (Pre-Cert) Program in hopes of creating a modern approach that will move software iterations through the pipeline while still ensuring high quality throughout the life cycle of the product. However, we don’t know how long it will take the FDA to make a decision about greenlighting the program for all companies to be able to apply for.

The government has yet to move at the speed of innovation. By the time guidelines or regulations are put in place, the associated technologies are often already obsolete. Now, it’s time to eliminate some of the regulatory hurdles that stand in the way of the latest wellness tools that consumers crave and deserve.

The Policies That Got Us Here

The FDA’s Digital Health Innovation Action Plan states that it will focus “oversight on mobile medical apps to only those that present higher risk to patients while choosing not to enforce compliance for lower-risk mobile apps.” But all this does is leave room for interpretation and create gray areas for both companies and consumers. This can result in questions arising about which technologies are safe for consumers after they have already been released to the public and after consumers have paid their hard-earned money for the product.

23andMe is a prime example. The at-home genetic testing service was not considered a medical device, so the FDA didn’t bother with oversight. The company launched its service to U.S. consumers only to have to pull some of its products once the FDA later raised questions around the company’s products — questions the FDA could have asked earlier had there been fewer regulatory hurdles standing in the way. While 23andMe has been able to rebound and relaunch its products, it wasn’t without a hit to its reputationand bottom line.

When this happens, companies have to invest more dollars and time to get approvals, meanwhile halting production and sales. They have to spend more money while they are earning less profit. It is a recipe to crash and burn, especially for startup ventures with minimal funding. For them, there’s a good chance they will go under by the time they can get the approval needed to market their product again.

One example is blood-testing company Theranos. Its “proprietary technology” was never validated, and the backlash from regulatory bodies after launching caused a financial and legal burden that the company is not likely to bounce back from.

So How Do We Bridge the Divide?

The road to recovery is a multilane highway. In one lane, the FDA has announced plans to improve the approval process with the aforementioned Pre-Cert program. Essentially a “fast track” for health tech companies, it would allow companies to skip traditional, slow-as-molasses FDA approval processes by being precertified. (Think TSA PreCheck for medical device companies.) This would allow trusted companies to launch new health products to consumers much more quickly.

While this is an encouraging move on the FDA’s part, some are raising concerns that it will pose more risks to consumers by allowing them to purchase products before there are evidence-based results from clinical trials. However, companies would have to meet certain requirements and quality standards in order to get the Pre-Cert stamp of approval.

Right now, Pre-Cert is only a pilot program extended to a select sample of digital health companies both big and small. The hope is that the FDA can identify which metrics are the most important in determining whether a company qualifies for precertification. With the focus on those metrics, companies would then have to submit less information in order to be approved, speeding up the process.

“These pilot participants will help the agency shape a better and more agile approach toward digital health technology that focuses on the software developer rather than an individual product,” FDA commissioner Scott Gottlieb said in a press release.

If the pilot program goes well, there is hope that the FDA will precertify more digital health companies that show sound testing and scientific validation practices. This would open doors for the public to take advantage of groundbreaking health technologies from qualified companies that were previously caught in FDA purgatory.

In another lane, there are larger tech companies beginning to use their power to push for more FDA and government action. This is good news for startups. For example, Apple is rumored to be seeking FDA approval for one of its Watch features, which might make it easier for other wearable startups to get approval for their own products.

Finally, there is consumer demand to lean back on. Given the uncertainty around healthcare in the United States, consumers want more information about their health to make more informed decisions, prevent or improve conditions and disease, and have more autonomy in their healthcare choices. As more of the population adopts digital health technologies, regulatory bodies will have no choice but to make sure they have an efficient process for evaluating them.

Once regulations are better defined, businesses will be more efficient, and consumers will get their hands on new health technologies that can help them realize improved health outcomes. The consumerization of healthcare will likely unlock behavioral change and reduce healthcare costs. We just need to get the FDA to get out of the slow lane.

Shireen Yates is co-founder and chief executive officer of Nima.

A Digital Health Revolution Is Happening Now, but the FDA Can’t Keep Up