“Healthcare Lawyer” vs “FDA Lawyer”

“Healthcare Lawyer” vs “FDA Lawyer”

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    In today’s video, we discuss the difference between “Healthcare Lawyer” and “FDA Lawyer” and what the distinction means in terms of your potential needs.

    Many of our clients upon watching our videos or reading our website take notice when we say “Healthcare and FDA lawyers” and they ask us whether these are the same thing, whether they cover totally different areas, or something in between.

    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. Today, I’m going to explain what we mean by each of these two categories, and give you the scoop on what each one really is.

    By the end of this video, you’ll know which areas Healthcare Lawyers and FDA Lawyers each cover, and where your potential legal questions and concerns fit into that picture.

    To begin, I want to dispel the notion that healthcare law is all about medical malpractice. It’s what physicians always think about first and foremost. What if they get sued? What if there’s a claim?

    Medical malpractice is actually a very small part of the market for legal services in medicine, let alone the wider health and wellness industry. In fact, for the medical malpractice liability risk, there is medical malpractice liability and most of the time, this doesn’t get triggered. The number or percentage of claims against primary care doctors are relatively low.

    Now, the way we break down this legal landscape is into two parts, to keep it very simple. First, there’s healthcare law, which applies to healthcare services in general. If you’re a doctor and you’re practicing medicine, you’re going to be governed by the healthcare laws of your state.

    For example, you’ll have a license from your state. The state medical board controls your licensure. What do you have to do to get licensed? What do you have to do to keep your license? What will get you into physician discipline, investigation, and possible loss of licensure, and therefore, what things are prohibited or what things are going to raise your risk profile, with regard to licensure and discipline?

    Now for the second piece of the picture. This is FDA and FTC law, which apply to health and wellness products. If you are a physician, or a layperson, or a venture, a business, let’s say a healthcare business, and you’re promoting a product, be it a dietary supplement, a cosmetic, a medical device, a drug, a biological, a vaccine, a probiotic, or a radiation emitting treatment, these are all going to be regulated by the FDA, which regulates products in interstate commerce, almost everything is interstate commerce, to have a health and wellness flavor orientation dynamic to them. It’s important to classify exactly what that product is so you understand how the FDA can exercise its jurisdiction.

    The Federal Trade Commission, the FTC, controls advertising. It regulates. It prohibits false and misleading advertising. You’re going to want to get FTC review for your advertising marketing claims for health and wellness products.

    So very simply, there’s health and wellness services, which are primarily concerned with what we call healthcare law, and health and wellness products, which are primarily concerned with FDA law. Depending on which side of the coin you are on, you may be a more natural match for a “Healthcare Lawyer” or an “FDA Lawyer.”

    But luckily for you, we practice both healthcare and FDA law, and whether you are a practice or a business selling a product you can always benefit from a legal review of your business arrangements and business plans to identify possible areas of legal risk and help you mitigate them,

    Thanks so much for watching. 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.

      Richard Freedland
      Richard Freedland GRAMedical, CEO
    • Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.

      James Riviezzo
      James Riviezzo Practice On Your Terms

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