Hiring a Healthcare or FDA Lawyer: How to Get the Most Value

Hiring a Healthcare or FDA Lawyer: How to Get the Most Value

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In today’s video, we talk about how to get the most out of your engagement with a healthcare and FDA law firm or lawyer.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group and we’ve advised over a thousand healthcare industry clients on healthcare and FDA legal issues.  These clients include healthcare startups that do integrative medicine, functional medicine, or telemedicine, and/or have a management services organization or MSO serving as the management and marketing arm, whether in a brick-and-mortar setting or via digital or mobile health.

When you hire a healthcare or FDA lawyer or law firm, you should look for three things: experience, knowledge, and strategic sense.

Experience, because the term “healthcare and FDA” law actually covers a huge arena of products and services.

We’re talking about a multi-trillion-dollar industry for human, and even animal, health and wellness.  It’s not just healthcare, it’s also health and wellness.

There are actually many different branches of law involved, ranging from federal statutes—such as HIPAA, or the Federal Food, Drug & Cosmetic Act—to state laws, such as those that govern physician licensure.

An experienced healthcare and FDA lawyer has, in their career, dealt with many different types of health and wellness industry clients, from service professionals to individual people and practices like chiropractors to digital health companies and healthcare startups.

Second, knowledge– now because laws governing healthcare are vast. You need knowledge because you are really learning a language, with all of its odd grammar rules.

And finally strategic sense, because the answers aren’t black-and-white.  Instead, we’re usually looking at a range of legal and regulatory risks and how the client might mitigate some of those risks, while still profitably pursuing the business opportunity.

When you’re looking for a law firm that does healthcare and FDA law, look for an A player and understand that, that healthcare FDA law firm is also looking for you. So we’re looking for an A client. Even for a Legal Strategy Session, we always send an intake form, which asks the client: “what will it cost you in terms of time, money, or reputation if you don’t solve this puzzle?”

Clients often respond by talking about how much opportunity they will lose if they don’t solve the legal puzzle right away.

Some talk in terms of the potential time, money or reputation losses if they don’t get clear resolution, pragmatic response.

One client very elegantly wrote that not addressing the legal issues, will: “possibly put us in a compliance nightmare with regulatory forces, and expose us to legal disputes.” On the other hand, if they get it right, they might just possibly change healthcare forever, and gain riches both monetary and emotional and spiritual in the process.

We strive hard to be an “A” law firm, and in turn, we look for “A” clients.

In fact, “A” clients understand that the law rarely gives a clear “yes,” and sometimes doesn’t give you a clear “no.”  Often, industry practice pushes the boundaries of existing legal rules, and legal rules and enforcement can also evolve to accommodate new business models.  At the same time, when the rules require strict compliance, it’s important to understand the clear lines and avoid violations.

Now, going back to the “A” client, we’ve actually taken time, thought and care to lay out what we consider an “A” client.  We care about it so much, we defined the criteria on our website, under External policies.

Thanks for watching. Here’s to the success of your healthcare venture, we all look forward to working with you soon.

Testimonials

  • 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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