Health Coaching Plus: FDA Medical Device and Legal Issues
Here’s today’s scenario. Joe is someone who took biology, chemistry, thought about going to medical school, but didn’t do so. Didn’t get a license although he’s got cousins that are nurses and doctors and psychologists, maybe Joe’s ABD with a psychology PhD. Anyway, Joe knows a lot about health. In fact, he’s buff. He’s got white teeth and a great smile and a fabulous relationship and wants to sell something, because he’s got the secrets to wellness. What he wants to do is he has this machine and this machine is going to measure something, and based on this machine, it spits out some super-secret information and that’s going to help people because he’s going to do some health coaching based on that. So that’s our scenario.
Hello, I’m Michael H. Cohen. I’m founding attorney of Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate the complex terrain of health and wellness laws and regulations so that you can scale or initially develop your health and wellness dream.
Let’s go back to our scenario. The interesting thing about this one is aside from Joe’s incredible good looks, charisma, and magnetism and ability to sell, is that he’s got two things going on at the very least from a legal perspective. One, he’s got the coaching. Two, he’s got the device. They involve completely different areas of law.
Now, if you could just take a healthcare lawyer over here and an FDA lawyer over there and then put the steel cap on them and then have some electrodes and transfer knowledge, I think you could probably solve that puzzle. But if you don’t, then you’ve got two people, each of whom is potentially an expert, potentially there’s that lawyer coming out of my personality, potentially an expert in their own domain.
That’s because I went with sci-fi metaphor, so I’m giving myself a little room here. It’s called personality. Sometimes attorneys have it, sometimes. Doesn’t happen very often, but any rate, and not very much. Can’t go out too far because we’re all about analyzing and mitigating risk.
Anyway, I still went with the purple shirt. I don’t know. I take risks sometimes. But seriously, the health coaching has got its own system of rules and it’s the realm of not being licensed as I think I indicated. But of course, more and more, coaching is acceptable. There’s an international federation. There are carve-outs. There are attempts to create a scope of practice through voluntary self-regulation in the absence of regulation.
If you’re going to do it, it’s good to have good documentation, good to have forms, and it’s good to try to create some boundaries, to sculpt some boundaries, so you don’t cross that fuzzy territory into unlicensed practice, which could come from three areas, could be unlicensed practice of medicine, psychology or nutrition and dietetics. Possibly something else, but I doubt it’s going to be electrical or plumbing. It’s going to be one of those big three most likely. So we could help with that with health coaching disclaimers, waivers, consent forms, whatever you call that document. But it’s a way to really clarify and contractually define what it is you’re going to offer the client who’s not going to be a patient.
Now, when you introduce the device, it gets a little bit more complicated because once you start measuring things and making claims based on measurements, you get to a whole other area of law, which has FDA law. So first of all, is it a medical device? Does it fit the definition of a device? Not surprisingly, that legal definition is similar to that of practicing medicine under the licensing law and that both of them involve diagnosis and treatment of a disease, illness, condition. Diagnosis treatment, again, we’ve talked about most of these concept elsewhere on our blog or in these videos at cohenhealthcarelaw.com.
The main idea is that diagnosis is a very broad term, so is treatment, and just using machine, having it spit stuff out and say, “This indicates such and such about your health,” it’s dicey. It’s one of those frontier areas that will only work if the enforcement around practice of medicine erodes, which I believe it will, as we continue accelerating in the 21st century. But in the interim, you have to be careful. You have to be careful on the FDA side as well.
There’s third area I haven’t mentioned, which is FTC, which is you want to be careful with your claims because your claims under federal and state advertising law have to be capable of substantiation, which means you got to be able to prove them, and normally, you have to have a reasonable basis for your ads. But for healthcare products, you’ve got to go beyond, above and beyond, and you have to prove by competent and reliable scientific evidence that the claim is true. True, not more likely true than not true. It’s competent and reliable scientific evidence.
Each of those words is important. So you’ve got a very high burden from the false advertising side. How do you look at these risks? Which is the most important? Where are you going to take a risk? Where are you going to stake your claim to your part of a multi-trillion dollar health and wellness money pot, adventure pot, pot of making people feel better, act better and live better?
Those are nuanced questions. If you think it would help, you might benefit from a consultation, then come book a legal strategy session with us. We can get you started. Otherwise, contact us online, cohenhealthcarelaw.com/contact to send us a message or book an appointment. I always say, here’s to the success of your health and wellness venture. We look forward to working with you soon.
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