The contracts or agreements don’t have to be too complex, but they should absolve you of any patient-doctor relationships you might inadvertently enter.
Clinical Advisor Contracts
Most companies will want to sign a contract with you. In it, they’ll say what you can and can’t do and how the contract might terminate.
There will be a clause about protecting business-related information and sometimes an NDA.
There might be a thing about patient-doctor relationships and malpractice coverage. This last part is what I would pay close attention to.
If you write up a clinical algorithm with your name, you must take responsibility for it. If someone is hurt by what you wrote, you may be held responsible, but unlikely from a med-mal perspective.
You can be sued by patients, patient interest groups, competitors, disgruntled employees of the company you are consulting for, or an insurance company.
What you don’t want, or at least I don’t want, is for my healthcare consulting to become a quasi-patient-doctor relationship.
As a clinical advisor, I advise the company on creating safe patient algorithms, from workflows to intake forms to management guidelines.
Clinical Advisor Role
A good contract starts with your main stakeholder. Is it the CEO of the company? The product manager? A project manager?
If this person is compassionate and well-intentioned, it’s rare for your clinical advisor role to go south. They know what to hold you responsible for and what to absolve you of.
The next best way to protect yourself is a legal contract. Almost always, there is a lot of wiggle room in these contracts because clinical advisory roles aren’t that common.
Getting Legal Help
Contract attorneys are plentiful, some more expensive than others. Working with someone who knows you and knows what a clinical advisor contract should be like will save a lot of time.
I review the contract first and then make suggestions to my attorney. It saves both of us time. I avoid numerous back and forths; most of our suggestions are accepted by my consulting client.
Avoiding Patient Harm
If you are writing a clinical workflow meant to squeeze money out of the patient without protecting them, it’s hard to defend that in court.
Most direct-to-consumer telemedicine companies these days do exactly that, but they have the know-how to write their algorithms in a way that protects them.
Demonstrating a little due diligence goes a long way. If a patient is being evaluated for a telemedicine visit that may result in a CGM device, are you asking all the right questions that would ensure patient safety?
What could go wrong with this patient? Where can they turn to if they have a problem with their device? Which patients are turned away, and which are ideal clients for this DME prescription? What case reports did you review before writing this algorithm?
Is there an internal process to get feedback on patient safety and make changes to the protocol? That’s your job as a clinical advisor.
Medical Advisor Agreement Sections
The medical advisor agreement is often drawn up by the company I consult for. I have this reviewed by my own attorney after looking it over myself.
It’s quite normal to bill the consulting client for the legal review. I don’t see anything wrong with that. When in doubt, ask.
1. Advisor Duties & Responsibilities
Fairly self-explanatory. What’s expected of you, and what are the terms of conduct?
2. Company Duties & Responsibilities
This is the part where you can make some edits. How can you ensure that you have a successful delivery of your deliverable?
I haven’t had to make many changes to these sections. Usually, it’s quite reasonable once drawn up by an attorney.
3. Contract Term
What’s the duration of the agreement between the clinical advisor and the company?
How can either party terminate the contract or under what circumstances would it get nullified?
This part is worth paying attention to if you are working with a company that wants to make this exceedingly onerous. My attorney often pays attention to this on my behalf.
Do you charge per hour or per delivered service, and at what hourly rate? Usually, there is an “exhibit” section that references your hourly rate.
6. Employment Type
Almost always, I will be a general or independent contractor. No matter how desirable it might seem, I have little desire to be employed by someone.
In a medical advisor role, the company is my customer, and I am the expert.
7. Clinical Responsibilities
Whatever clinical algorithm I create, it has to be medically sound and protect the patient. This is my clinical responsivity as a clinical consultant.
Remember, this part can later get you into hot water if there is some assumed patient-doctor relationship here. I make sure this part of the contract is very clear that I am offering general medical advice with no patient-doctor relationship whatsoever.
There is an Errors & Omissions insurance you could carry. Depending on the breadth of your work, it’s worthwhile to consider this.
If you have to purchase malpractice
HIPAA – good old HIPAA. It’s your duty to protect patient health information and respect state laws regarding the storage and management of clinical data. That’s the BAA.
Don’t share what you do with this company with other people if it risks their competitive edge.
Many contracts will write something along the lines that you cannot work for competing companies or take this information to competitors.
As an independent contractor, I will choose any client I want but will not jeopardize my client’s competitive edge. Your attorney can word that better.