Here’s How Apple And Google Are Helping The FDA Make Major Changes In Healthcare

It’s always nice to know that the prescription drug you’re about to wash down with a glass of water has been FDA approved. It’s a stamp of approval that lets you know whatever you’re about to put into your body has been rigorously tested by some very smart people.

On the other hand, “These statements have not been evaluated by the FDA,” tends to leave most of us with some doubts. It’s understandable. We want to know that the medicines, supplements, and food that we put into our bodies are safe.

But what about digital healthcare tools? They don’t necessarily affect our health as directly as a pill, but they work to improve or monitor it in a variety of ways. Should the FDA regulate those, too?

The FDA Weighs In

The answer looks to be… somewhat. Apple, Google, and a variety of other tech companies are developing medical apps and devices for patient use. The FDA has announced that it will be monitoring these apps and devices — but differently than it does pharmaceuticals or medical devices.

The FDA has chosen nine companies to participate in a new program for digital health technology. They include the big names you might expect — Apple, Google, Samsung — along with some others like Johnson & Johnson and Fitbit. And it seems that the program will be more of a partnership than direct oversight by the FDA.

A New Approach

The approach the FDA is taking isn’t anything like the one it takes for new drugs. Instead of focusing directly on the products themselves, the FDA is going to focus on approving the companies that develop the products. So rather than evaluating every new app or wearable device, the FDA is instead going to examine and approve certain companies who make them. The companies they’ve chosen will go through a type of pre-certification that will allow them to develop with less oversight.

That’s a big incentive for these companies to open their doors to the FDA. They open up and let the FDA poke around, and suddenly there’s much less red tape in the way of their product. The FDA chose just nine companies out of more than 100 applicants. So there are plenty of companies out there that would agree to participate in this oversight program if it meant they could develop their products faster.

What This Means

It looks like the FDA is trying to streamline its approach to new technology. After all, a new drug can take a decade to roll out and has to be tested extensively before it’s approved. A new app? Often less than a year. There are plenty of new and exciting products coming to the market very quickly, and the FDA doesn’t want to suddenly pump the brakes on that. At the same time, they may also be a little uncertain of where they stand in digital health. These aren’t medicines, they aren’t devices being implanted in someone. It’s unknown territory for them when they look at their regulatory powers.

But the FDA recognizes that they need to change certain aspects of their regulatory framework when dealing with new technology. For now, I think that’s probably a good idea. It allows them to dip their toes in the waters of digital health and begin to really get an idea of how they’re going to regulate it.

Looking Forward

A perfect example of an area where the FDA could potentially have a real positive benefit is wearables. Wearable devices like the Apple Watch are now starting to cross over the line from ‘fun and fitness’ to real health monitoring. Apple has said that its watch can now detect an irregular heartbeat with 97% accuracy. That’s huge for someone suffering from atrial fibrillation or an arrhythmia. If consumers (patients) are going to use the Apple Watch to monitor for irregular heartbeat because of certain risk factors they have it’s a good thing that the FDA is evaluating their options here. In the industry as a whole, I think most companies are sticking to high standards. But as a consumer, you just feel more comfortable knowing that there are some regulations attached to the product you’re using. People like to know that someone’s out there keeping an eye on these products.

So we’re going to see a significant uptick in the digital health tools being offered. But it’s also important that patients know how to properly use these devices, that they’re appropriately monitored, and that they have some assurances about how effective these products are.