Do Healthcare Startups and Coaches Need Informed Consent?

Do Healthcare Startups and Coaches Need Informed Consent?

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    In today’s video, we discuss what you need to know if you’re a healthcare company or coach who need a consent form.

    I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We help healthcare industry clients just like you navigate healthcare and FDA legal issues so you can launch, or continue to scale, your health and wellness product success.

    If you’re a healthcare company or coach, the informed consent is same as it ever was.

    Oh, I just quoted The Talking Heads: same as it ever was. Remember that one?  From Stop Making Sense? Well, let’s make some sense here.

    Informed consent is same as it ever was because it goes all the way back to 1914.  In a New York Court of Appeals case called, Schloendorff v. Society of New York Hospital, Justice Benjamin Cardozo explained the principle of informed consent, writing: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages. This is true except in cases of emergency where the patient is unconscious and where it is necessary to operate before consent can be obtained.”

    There are three elements to an informed consent: One: benefits of the procedure; Two, risks of the procedure; three, reasonable and feasible alternatives.

    Informed consent is a requirement for medical procedures, yet we’ve also extended that model to other professions, as precautionary documentation.  So, for example, take the physician who wants to remove their medical hat and offer services as a life coach or health coach.  (We have a lot more on coaching legal issues in other videos and blog posts). But to the point here, they might have a consent form that says something like this:

    Benefits of health education and life/health coaching include: ease and feeling of overall well-being, reduction in stress levels, better sleep, weight loss, increased energy, increase in overall health and wellness, and reduction in health ailments. Alternatives include self-help techniques and medical or psychological care.  Risks of both include distress, mental health issues that require a licensed healthcare provider, dissatisfaction with results, and over-reliance on health coach.

    Now, this isn’t magic language, there’s no guarantees, but it’s protection. It’s like a seatbelt and it’s meant to be overinclusive rather than underinclusive.

    Now there are some more things the consent form should say.  For example, if the clinician is trying to disclaim professional services (I’m not offering medical services, i’m just a coach here, )— the consent form should say so, it’s an assertion.

    There might be some language about nutritional practice, depending on the state’s specific rules around who can give nutrition or nutritional advice.  Again, nutritional coaching is a topic we cover amply in other posts and videos.

    Now with respect to social media, messaging systems and email, you might want to insert some cautionary language about risks related to online communications, privacy and security.  This doesn’t mean you won’t abide by reasonable privacy and security precautions—as required by HIPAA, or, potentially, state law.  You have to abide by them.

    Remember that the rules governing HIPAA and state privacy and security law are separate and apart from the laws governing informed consent.  So, it’s important to have a good healthcare lawyer whose approach is synergistic, cross-disciplinary, inclusive, who can spot the issues and make sure that you have overall coverage.

    There might be language to handle group sessions and group communications, if the business model involves group work, for example.

    And we might also insert a provision for arbitration rather than litigation.

    If you’re interested in an early read on your healthcare business model, you would probably benefit from having a Legal Strategy Session with a member of our Legal Team.

    Thank you for watching. If you still have questions, click on the link below,, to send us a message or book an appointment. Here’s to the success of your healthcare venture, we look forward to talking with you soon.


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      Richard Freedland GRAMedical, CEO
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      James Riviezzo Practice On Your Terms

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