How to Draft a Telemedicine Informed Consent

How to Draft a Telemedicine Informed Consent

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In today’s video, we discuss whether you need a specific type of consent form to offer patients telemedicine or telehealth services.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We’ve advised over a thousand or more healthcare industry clients to navigate healthcare and FDA legal issues and as a result, they’ve been able to successfully launch and grow their health and wellness product or service.  Imagine how far down the curve your healthcare business or practice could be with focused legal advice.

Well, recently, Dr. Jane came to us with this question: “My clinic needs new consent forms to include telehealth services.  Can you draft a consent form, and any other required forms to do telemedicine?”

Of course we can! When it comes to informed consent, there isn’t really a secret sauce, but there is good language.

What is informed consent?

It’s the patient’s right to be informed about all critical decisions when it comes to their health.

This requirement of informed consent is sometimes enshrined in a statute, yet more often comes from the common law, as it was famously articulated by Benjamin Cardozo, a Supreme Court Justice, many decades ago.

Informed consent is also an ethical requirement.  And if you don’t give sufficient informed consent, the patient could have a claim for medical malpractice.

There are three things you need to tell a patient in the informed consent process:

Number one, the risks of a therapy.  Number two, the potential benefits of a therapy.  And three, the reasonable and feasible alternatives.

Now this is important especially with anesthesia and surgery, where foreseeable risks can include death.  That is why you see those long consent forms at the hospital.

In other clinical practices, although the forms may be less detailed or shorter, they still include a list of the procedures, and the risks, benefits and alternatives.

For example: procedures, for a naturopathic medical doctor, might include various dietary supplements and botanical medicine, and these have various clinical risks and benefits, and there are conventional alternatives.  All this should be described in the form the patient signs, after a discussion between the doctor and the patient.

In telehealth, the biggest potential benefit generally is improved access to care; and the biggest potential risk comes from gaps or failures in telecommunication.  Now there is some protective language we can draft here which helps the healthcare practice or business, at least in terms of laying out to the patient what the benefits, risks and alternatives actually are, which is what informed consent requires.

We also can have some telehealth-specific disclaimers.  For example: “By using telehealth, I will not have an in-person visit and physical exam with my practitioner which could provide important diagnostic and treatment information to my practitioner. I understand that my practitioners, in making diagnostic and therapeutic determinations, rely on any representation that the information I submit is truthful and accurate.”

So we can add this kind of protective language or other protective language, which I call the “bells and whistles” section of the form.  You may not necessarily need it, but better to have it than not have it when needed.

While the informed consent in telemedicine is important, it’s not the only document you need.  We also draft notices about your insurance policies and practices, and general office policies that govern the way you handle the patient.

And then, of course, there are the privacy and security documents, such as those required by HIPAA or state law; and the Terms of Use for your website, which also contains important disclaimers and limitations of liability for your healthcare business or practice.

Now, Informed consent may not be the most exciting topic at a cocktail party, even if you’re at a black-tie for medical professionals; but it is bread-and-butter, meaning absolutely necessary for a healthcare practice and for many telemedicine companies as well to have good, strong informed consent on the record with protective language.

Thanks for watching. Here’s to the success of your healthcare business or practice, we look forward to speaking with you soon.

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