Joe, not the plumber, but the app developer, has an app that combines virtual reality health coaching, personal fitness training and nutritional advice.  Joe has come to us for legal advice because of our expertise in health and wellness businesses.  What does Joe need?

Many of our clients have asked us this question: Here’s my business, what do I need?

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients navigate healthcare and FDA legal issues and launch or successfully continue to grow their health and wellness product, service, or platform.

While we could talk about the different kinds of documents that Joe needs drafted for his virtual reality, health coaching, personal fitness training / online digital gym – such as a privacy policy, a terms of use for his website, and some basic contracts with his practitioners, customers, suppliers, vendors – let’s hone in on what he needs from a regulatory perspective.  Because that’s a perspective that their corporate business lawyers missed.

Joe’s first set of lawyers gave him an unbelievable deal on startup legal services, supposedly, but they missed the important regulatory issues.  So now Joe is starting from scratch, and he has to salvage and completely redo his business model. This has happened to many clients who have come to use from other lawyers.

If you look at the universe of health and wellness services, think about it this way – you can divide them into basically two kinds of services.  One consists of those that require a license of some sort from the state.  We’re talking about a license as a healthcare practitioner – as opposed to, say, the license to open up a facility, which is completely different.

And the other is the world of unlicensed or non-licensed practitioners.

Working as a medical doctor, registered nurse, physician assistant, dentist, clinical psychologist or social worker, these things require a State license.  While working as a health coach, exercise physiologist, life coach, fitness guru, these things don’t require licensure.

One of the key concerns is that, if as a healthcare startup, you either rely on personnel that are not licensees, or, they are licensed yet you intend to deploy them for virtual telehealth tele-something visits across states, you have to be careful that the business model doesn’t intrude on prohibitions against corporate practice of medicine, individual practice of medicine and psychology.

Some states do require licenses for various things, while others have a system of “registration.”  Complicating things, there’s “certification,” which multiplies regulatory confusion.

The map really is all over the place, which is why you can’t just look online, try to find some map and figure it out.  If you have a business that’s not just a hobby, it’s good to have a professional legal eye on your business model, documents, and materials. That’s what we’d recommend.

Remember that the risk of unlicensed practice is a big one; it’s a felony or misdemeanor, and, private plaintiffs and all sorts of other government actors, they love to piggyback and jump in on an investigation by the State or even pre-empted.  It’s better to be safe than sorry, at least to know your risk and take steps to reduce the exposure.

Thanks for watching. We’re with you. Here’s to the success of your healthcare venture, we really do look forward to speaking with you soon.