In today’s video, we revisit a healthcare startup that wants to do telemedicine (but really telehealth), but they want to stay within the coaching model. So, is this possible? Is it okay to have a telemedicine that isn’t really “medicine?”

Of course, there are lots of healthcare startups today are setting up virtual health coaching, mind-body interventions, and every variation, like tracking exercise, calories, nutrition, mood, lots of other variables.

Hi everyone, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients like you, navigate healthcare and FDA legal issues so you can grow your healthcare business.

Today’s hypothetical client asked: how can we establish our health coaching mobile app and software platform without risking unlicensed and corporate practice of medicine?  If a coach gives advice and the client gets injured, is that malpractice? Can we get sued? What kinds of consent forms do we need for our coaching groups, as well as our individual clients?

And can our coaches recommend dietary supplements? Can they recommend nutritional plans, or is this considered unlicensed practice of medicine, is it considered “prescribing?” What kinds of disclaimers or waivers can you draft?

These are the kinds of questions we deal with day in and day out.

As a brief snapshot, first, we want to distinguish clinical recommendations from giving information and education.  There is a free speech kind of exception for online dissemination of health and wellness information, the challenge though is when a health coach individualizes, customizes, and stylizes their advice—particularly where the client has a clinical condition, for example obesity, depression, insomnia—this can be scrutinized by regulatory bodies like medical boards.

There’s a natural collision here between the strictness of the rules on the books—what the laws say—and how they might be interpreted if enforcement is aggressive; and what the health and wellness and coaching industries actually do every day.  Titrating this risk between the two worlds requires lots of careful legal advice, and good business judgment together with the entrepreneurs.  As general advice, coaches should stay away from diagnostic labels and language, and, style their recommendations in terms of habits and goals.  For example, don’t talk about depression and obesity, coach on how to maintain an optimum state of mind and eat foods that are nutritionally dense and calorically low.

A second important key here is that disclaimers can help manage customer expectations, but they will not go the distance with regulatory boards.  More important is the actual business model.  That is why we normally recommend what we call a Legal Strategy Session as the first step in getting your model sorted out.

If the health coaches want to order labs and other questions that comes up, does that up the ante in terms of regulatory risk?  Yeah, sure it does. And since protected health information may be involved, consider some basic steps toward HIPAA compliance, which we talk about in other videos and also on our blog.

Thanks for watching. Please connect with us with your questions. We look forward to talking with you soon.