This is Pat Salber with Dr. Waysin and I'm at MedX at Stanford and we're going to talk law. I have with me today Michael H. Cohen, who's with the Michael H. Cohen Law Group. That makes it easy Michael. Thank you for that. So easy to remember. My pleasure. And Michael just gave a fantastic talk about an area that a lot of people I talked to were really concerned about and that is what can they and can't they do with or without FDA regulation. What are the implications of HIPAA and all those other kinds of legal issues that people struggle with. So Michael I was hoping we could start out by talking a little bit about this whole issue of FDA versus non FDA and how does the company, besides hiring you and maybe in addition to hiring you, how do they decide whether they need to go the FDA route or whether they can go another route. Sure well, what they need to decide first of all is whether they have a medical device or not. So part of what I talked about is when do you know whether an app or wearable is or is not a regulated medical device. And to help with that, the FDA has promulgated a guidance document which basically says there are three categories. These are the ones we call mobile medical apps. They're regulated medical devices. These are not MMAs or medical mobile medical apps. And these were not sure what we're going to do. So it's undecided there's enforcement discretion. And the bottom line is that those apps that are intended to diagnose or treat disease, those are in the regulated category. So it's very important when you're putting your strategy together that you look at what the claims are that you want to make for the product because those claims can turn your product into a regulated device. You gave some pretty subtle examples though. But let's talk about there's so many devices out there for sleep. And you gave an example that I thought was pretty subtle between deciding whether I'm an MMA device or whether I'm in the unregulated category. So part of the issue is determining whether what you're 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 actually borrowed from the dietary supplement category. The example is if you're saying that the product helps you sleep, you're just making a general wellness claim because people need to sleep. It's part of being human. But if you say it helps you sleep, if you have trouble falling asleep, now you're talking about curing insomnia. So it's very easy to ratchet up a general wellness claim into something that's a disease claim. And a lot of it is about language and being smart about your wordsmithing. Yeah, but it is really word smithing because why would I use an app for sleep if I wasn't having trouble sleeping? So it's really just about what words you use. And how much trouble are people actually getting into? I know with the supplements, I recently wrote a story about nanosilver which got into trouble because they were claiming that they cured Ebola, even though it had been on the market as a supplement for a very long time. Are there companies in the wearable space that actually are getting slapped around by the FDA? Well, one of the points I made in my talk is that the risk is not just the FDA but also the federal trade commission and there's a risk from private plaintiffs. So there's a lot of exposure. So it's easy in a sense to pick on this sleep example because it isn't part of language game. It's very hard to say what's wellness and what's medicine. At the same point, you make a really great point which is that people can't go around making wild claims. They can't make claims that are unsupported and unsubstantiated. So for example, a company recently got into trouble for making claims about its sleep tracking function. And the plaintiffs claim is that the sleep tracking function doesn't really work as effectively as it says it works. And so people are not getting as much sleep as they should. Now I'm a new parent so I know about sleep deprivation and you'd like to- Thank you. Congratulations. And you'd like to have the pleasure of measuring it with some accuracy. So there is an issue with people taking claims too far. Well, is that going to bleed over though into the kind of wearables that everybody's using? Because we have seen that a lot of, let's say, measuring steps that there's just like the old pedometers that we used to clip on our waist. Even the sophisticated wearables have a lot of variability and who knows what is accurate. And maybe that's lower risk than making a claim about speech. Are you going to see this bleed over into the more common wearables? Yeah, definitely. I think we're going to see more and more litigation. We're going to see more and more liability. And we're going to see less predictability as the technology accelerates because what it's actually doing in the big picture is it's blurring this line between general wellness and medicine. So in the old days, if you had a pedometer and it would simply measure something, that was useful to you. But now you'll be sharing that information with your doctor. You're doctor will be feeding back information about your condition from that. And so it's hard to say where general wellness ends and medicine begins. They're bleeding one into the other. It's an interesting metaphor. It's more like they're over. Let's use a help. I like the bleeding. There's sort of like a vendigram and some peas are not cues, but everything is sort of morphing into everything else. And so it's becoming harder to regulate and to say what's what? So I know you and I aren't going to solve that. But anything on the horizon that gives us hope to think that we will be able to work through these nuance differences and kind of the morass that people feel around regulation. Is there anything going on at the federal level that makes you think that this is going to get clearer or do we all just need to go and find Michael Cohen's to hire? Well I love business so please come to me. That'd be wonderful. I would say that one thing that the FDA has done positively is well two things actually it's created this mobile medical app guidance which is useful. And the carving out of general wellness low risk devices. So if your product is something that has relatively low risk it's pretty safe. And it doesn't make disease claims. 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. FDA has said we're going to carve those out. We're not going to go after those. So I think we're seeing a positive movement and a recognition that these accelerating technologies do promote health and that they're useful and that consumers and doctors need to be talking about them. So I think read the guidance and look for what's coming out because there are aware people out there that are at the forefront making change. Well fantastic. Thank you very much Michael for spending time with us. Thank you. It's a pleasure. Appreciate the interview.