Healthcare Startups Don’t Miss Critical Regulatory Risks

Healthcare Startups Don’t Miss Critical Regulatory Risks

In today’s video, we talk about the regulatory issues that healthcare startups can face, and why it’s important to understand that these regulatory risks can trip up the healthcare venture.

Hello, I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised so many healthcare startups on healthcare industry and FDA legal issues. Our clients are very broad, they include healthcare startups that do integrative medicine, functional medicine, telemedicine, they have coaches nationwide, they have a management services organization or MSO serving as the management and marketing arm, they’re in a brick-and-mortar setting or maybe they’re providing services via digital or mobile health.

Whatever they are, they also have a slew of innovative wellness, health, lifestyle and fitness products. They’re also could have physical consumer products like the gizmos that you put in your briefcase or digital apps intended to move the needle for your overall health.

I remember back when I was a law professor, and I came across this field of study in healthcare law called bioethics. Now, it’s a little far field with all the technology, but I remember hearing a lecture on the ethics of end of life care. The man at the front of the room was talking about patient autonomy, informed consent, medical paternalism and various bioethical values, in this very humanistic, caring manner, and I remember thinking to myself, “hey, that sounds to me like Buddhism!”

Of course, I had studied at an interfaith seminary, on the weekends, during my time as a corporate lawyer on Wall Street, so I was excited to recognize these parallels between healthcare law and ethics on one hand, and a major world religious tradition on the other. It could’ve been several traditions.

In my own career path, I was privileged to spend time in hallowed halls of universities, from Columbia University in New York City, to being on faculty at Harvard University, Harvard medical school. And now, I am privileged to spend time in the hallowed halls of my own Firm, well it feels that way, I feel that my work with clients like you is the culmination of everything that I’ve done in the past in my career.

Because what we’re really doing, is we’re talking about healthcare and all of its many dimensions, from the most technological, from digital medicine, artificial intelligence, infused software, medical devices, whatever is at the forefront – you know, all the way back to the ancient traditional practices, and things that have helped human heal, there’s a lot of PTSD today, mental healthcare, behavioral health, the whole gamut, the whole spectrum.

Well, thanks for watching. We look forward to speaking with you soon about your healthcare venture.

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