Hi, I’m Michael H. Cohen. I’m founding attorney at Cohen Healthcare Law Group. We provide legal strategies and solutions to businesses that accelerate health and wellness.

Today, let’s talk about fertility clinics. Fertility clinics are just one example of a specialized kind of center that’s going to be regulated in healthcare.

It could be an addiction center, it could be a health and wellness clinic. Could be IV hydration, sleep medicine, women’s health, men’s health, sports medicine. So today, fertility clinic. So very similar issues.

First of all, comprehensive patient consent form. And we helped one such clinic develop a detailed consent form and the idea was to prevent them from being burned, for having something that was too thin and didn’t really describe the risk and benefits adequately.

Secondly, data privacy. HIPAA is always something to think about in healthcare. So, you want to think about policies, procedures, data protection, IT policies, backup, encryption, appointing privacy and safety officers, the full suite of privacy and safety compliance.

And third, there might be specific rules applicable to reproductive technology. For one thing, the therapies could come under scrutiny. There are, you’re talking about products now suddenly are in the realm of FDA law and it can govern what the product is. Is it a medical device? Is that a supplement? Is it something cosmetic?

Or is it a combination product or is it a new drug or a biological? How strictly are these things regulated? So, finding the right FDA category might be part of your overall suite of legal needs.

If you’d like to dive deeper into any of the topics we’ve talked about today, reach out to us. Click below. We’d love to talk to you. We look forward to it.