Laws Governing Regenerative Medicine & Stem Cell Practice in Medical Spas
In today’s video, we provide general guidance to medical doctors and medical spas about handling laws and regulations governing regenerative medicine and stem cell practice.
I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised over a thousand healthcare industry clients on healthcare and FDA legal issues. Our clients include medical spas and healthcare companies that work with stem cell therapies, regenerative medicine, and the latest therapeutics.
In our prior video, we gave these three tips for medical spas and physicians doing regenerative medicine therapies in the aesthetics practice.
First of all, don’t look for a yes/no answer; rather, look for a risk assessment from your healthcare lawyer, which can help you make a solid business judgment as to where you want to take measured risks.
Second, some of the most important questions have to do with state licensure which spells out exactly who can do what, when it comes to cosmetic treatments in situations where the practitioner is not a licensed medical doctor.
Third, don’t take others’ advice and examples as true statements of what the law actually says.
Today we’d like to add on to those 3 tips, tips number 4 and 5.
Tip number 4: whatever the manufacturer tells you what is legal or lawful to say or not to say, that’s probably, in our experience, bad or wrong advice. Ignore it; but most importantly, get your own legal counsel.
Recently one of our medical spa clients was using some centrifuge or other machine that supposedly would do something with the stem cells that made them easier to inject, better, stronger, faster stem cells.
Remember that movie, the Six Million Dollar Man? Technology made him better, stronger, faster. That was the promise of these stem cells. And in this case the manufacturer was full of marketing language that talked about compliance: FDA compliance, HIPAA compliance, and compliance everywhere. None of it, of course, was true when you look into what they’re actually saying.
While FDA does not regulate the practice of medicine as a service, FDA does regulate stem cell products under the HCT/P protocol. That stands for Human Cells, Tissues, and Cellular and Tissue based Products.
The manufacturer in this case completely ignored these rules and made up its own marketing claims and even made its own FDA rules.
So, tip number 4, some are honest, but in general you can’t rely on what the stem cell or any other manufacturer or distributor tells you. Do your own independent legal research.
Tip number 5, make sure your healthcare and FDA lawyer understands the many interlocking layers of law.
We’ve already mentioned that medical doctors and other healthcare practitioners are normally licensed by the state and that state allows them by the license to do certain things and prohibits them from doing certain other things. Even medical doctors, who are supposed to have an unlimited license to diagnose and treat disease under the law, are limited by standard of care—that is, they can only practice in a way that meets what the medical board by professional consensus considers the standard of care.
And doctors have to abide by federal laws such as those governing the manufacture and distribution of stem cell products, and also that whole suite of law is governing advertising and marketing for all of the therapeutics including stem cell products and regenerative medicine.
Now, HIPAA is its own little separate statute with legal obligations that are distinct from FDA rules and licensing laws.
And then there is informed consent, a whole other world.
It just goes on and on like this. All these layers of law intersect and interlock, which is why we often refer to healthcare law as a Rubik’s cube of regulation and obligation. You have to follow all the threads, all the blocks and make sure that you understand how they work synergistically.
It’s kind of like understanding herbal medicine or any system of healing. There isn’t just one active ingredient, like you have in a drug-even in drug. But in plant medicine, while we can understand the impact of various phytochemicals in a scientific sense, we also know that all the ingredients work together in ways we don’t fully understand to produce certain outcomes.
Of course, as you know, I’m all for scientific method, and I’m all for breaking things down and breaking down systems into their component parts as one methodology for discovering the truth. And also as a legal scholar and attorney who has written half a dozen or more books on healthcare law governing complementary, integrative, traditional medicine, I also appreciate how whole systems are more than the sum of their parts. That’s the premise of “wholism”.
I approach law the same way. We work like you on a systems level, as well as rigorously analyzing the individual components.
Thanks so much for watching. Let’s talk about stem cells or regenerative medicine and the law. Here’s to the success of your healthcare venture, we look forward to speaking with you soon.
I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.
Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.