There are so many things to worry about when you are a healthcare startup entrepreneur: Will your product idea work? Can you actually build it? Will you be able to raise money? And, what about the dreaded FDA? Will your product require FDA (or FTC) approval?

Even though the FDA released guidance to help entrepreneurs understand whether any given mobile app needs to be regulated, I jumped at the chance to chat with legal expert Michael H. Cohen after he presented on the topic at the 2015 MedX on the Stanford Campus.

I started our conversation by asking Michael how a company can decide if they need to go through the FDA route or not? He said,

“[Companies] need to decide, first of all, whether they have a medical device or not. So…how do you know whether an app or a wearable is or is not a regulated medical device. To help with that, the FDA has promulgated a guidance document that basically says there are three categories: mobile medical apps (MMAs) which are regulated medical devices, devices that are not MMAs, and those they are not sure what they are going to do; its undecided and there is enforcement discretion.”

MMA vs nonMMA (Michael E Cohen)

“The bottom line is that those apps that are intended to diagnose or treat disease are in a regulated category. So, it is very important, when putting your strategy together, that you look at what the claims are that you make for the product because those claims can turn your product into a regulated device.”

I pointed out that he gave some pretty subtle examples of what were and what were not MMAs in his presentation, including devices used for sleep. He responded by saying,

“Part of the issue is determining whether what you are doing is diagnosing or treating disease which puts you in that regulated category or just doing something for general wellness. So, the example that I gave I actually borrowed from the dietary supplement category. If you are saying that the product helps you sleep, you are just making a general wellness claim because people need to sleep. It’s a part of being human. If you say it helps you sleep because you have trouble falling asleep, now you are talking about curing insomnia. So it is very easy to ratchet up a general wellness claim into something that is a disease claim. A lot of it is about language and being smart about your word-smithing.”

How much trouble are people actually getting into? Are there companies in the wearable space that are getting slapped around by the FDA?

“The risk is not just the FDA, but also the Federal Trade Commission (FTC). And, there’s a risk from private plaintiffs. So, there is a lot of exposure. It’s easy to pick on the sleep example because it is, in part, a language game. It is very hard to say what’s wellness and what’s medicine.

At the same time, people can’t go around making wild claims. They can’t make claims that are unsupported and unsubstantiated. For example, a company recently got into trouble around its claims for its sleep tracking function. The plaintiff’s claim is that the sleep tracking function doesn’t really work as effectively as they said it would. So people are not getting as much sleep as they should…there is an issue with people taking claims too far.”

I asked if this was going to bleed over into the more common type of wearables that everyone is using, say those that are measuring steps? Just like the old pedometers that we would clip on our waist, even the most sophisticated step counters have a lot of variability and who know’s what is accurate.

“Yes, definitely. I think we are going to see more and more litigation. We are going to see more and more liability. And, we are going to see less predictability as the technology accelerates because what it is actually doing, in the big picture, is it is blurring the line between general wellness and medicine.

“In the old days, if you had a pedometer, it would simply measure something that was useful to you. But now, you will be sharing the information with your doctor and your doctor will be feeding back information about your condition from that. So, it is hard to say where general wellness ends and medicine begins. They are bleeding one into the other…it is becoming harder to regulate and say what’s what.”

Is there anything on the horizon that gives us hope that we will be able to work through these nuanced differences? Or, do we all just need to go and find Michael Cohens to hire?

“[Two things] the FDA has done positively. It has created the Mobile Medical App (MMA) guidance, which is useful and the carving out of general wellness low risk devices. If your product is something that has relatively low risk—it is pretty safe—and it doesn’t make disease claims [rather] it makes claims more in the general wellness space, it makes claims that the product allows you to live a healthy lifestyle (things that have to do with eating nutrition, general health habits, fitness)…

general wellness products for regulatory purposes

The FDA has said they will carve those out and not go out after them. So, I think we are seeing a positive movement and a recognition that these accelerating technologies do promote health and that they are useful. And, consumers and doctors need to be talking about them. Read the guidance and look for what is coming out because there are aware people out there that are at the forefront making change.”


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