In today’s video, we talk about some of the legal lines between the practice of medicine and psychology, and health coaching.

Hi, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate the complicated terrain for healthcare and FDA legal and regulatory issues so you can launch, or continue to scale, your health and wellness service or product.

Here’s today’s healthcare law scenario.  Bob, a licensed naturopathic doctor, an ND, lives in a State that licenses NDs.  He wants to offer an online course that addresses different mental illnesses.  As the course is online, customers will sign up from states across the United States.

The course will include education on what kinds of labs customers can order on their own, without a doctor’s order or prescription, and, online information about dietary supplements that are helpful for mood disorders, anxiety, depression, insomnia, ADHD, and other emotional issues.

Then, the website or app that Dr. Bob attends will have a button where customers can order their own labs and supplements as well.

Bob wants to know, if he offers this course, and the order-it-yourself lab tests, and supplements available online, will he face any legal and regulatory exposure?

Bob’s proposed business model here raises a number of legal issues that we are going to spot.

First of all, even if all he does is provide links to other sites or portals through which the customer can purchase dietary supplements, still Bob could very well be seen as a distributor of dietary supplements in interstate commerce.  As such, he must be careful about the claims that he makes for these dietary supplements, and the labeling, which includes the claims and statements on his own website and marketing materials.  If Bob links to publications that discuss diseases, such as anxiety, depression, attention deficit disorder, or other emotional states and psychological disorders, then Bob risks making a disease claim, which FDA disallows for a dietary supplement.

If you’d like to more about disease claims vs. structure/function claims, just search on our YouTube channel or the video blog on our website, cohenhealthcarelaw.com, for other videos that talk about these FDA issues.

Note that Dr. Bob also has to comply with FTC rules, and avoid deceptive and misleading advertising.  This means that all of his claims regarding the dietary supplements must be supported by “competent and reliable scientific evidence.” Again, we have other videos that drill down into FTC’s competent and reliable evidence standard for healthcare products.

Next, Bob should be mindful of legal rules prohibiting unlicensed practice of medicine and unlicensed practice of psychology.  Even though Bob is licensed as an ND in the state where he lives, unless there is some telemedicine waiver or telemedicine allowance in the remote state where the customer lives, normally Bob cannot practice “medicine” across state lines; and, since he is not a licensed psychologist or licensed mental healthcare clinician, Bob, might, despite his medical licensure be crossing the line here as well.

Unfortunately, Bob also has increased risks precisely because he is so steeped in the science.  He wants to talk about “moods” and “habits,” which a little softer than mental health diagnostic categories; but, he also wants to discuss brain imbalances and fMRI research about cognitive issues and all sorts of scientific data.

As to the labs, there’s some issues, there might be some wiggle room if FDA has listed the lab test as being over the counter (OTC), but then again, the role of interpreting lab tests would raise legal risk.

You can see there are a lot of nuances here.  As we’ve discussed on our blog and in other videos, disclaimers are helpful, disclaimers on Bob’s website – we draft those, although, they do not make him bulletproof. They don’t make you legally bulletproof.

If you have a business model like Bob’s, and, you’re interested in an early read, you would likely benefit from what we call a Legal Strategy Session with one of our attorneys. This is the very step in your journey.

Thanks for watching. If you still have more questions, contact us at cohenhealthcarelaw.com/contact, to send us a message or book an appointment. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.