Telemedicine & Informed Consent: How Informed Are You?Telemedicine, and mobile health growth have accelerated more quickly than regulations can be written.
It used to be (back in the old days) that “doing” telemedicine (TM) was so new and foreign to everyone that it was considered research, and thus required—at most institutions—human subjects or Internal Review Board (IRB) approval. Patients had to be consented into a study prior to engaging in any sort of telemedicine encounter.
Thankfully, for the most part, those days are gone. While some institutions may still require IRB consent, that number has decreased significantly. Of course, if you are conducting a scientific experiment using a new telemedicine device or some new procedure, that study will have to go through the usual IRB approvals and involved patients will need to be consented.
This does not mean, however, that consent is gone for “every-day,” routine teleconsultations. What is generally required now is the type of informed consent that any patient signs when receiving medical care. That consent for telemedicine, however, comes in different flavors. Some states just require the standard patient consent to be seen without any additional language about telemedicine. Some require the standard consent to have additional telemedicine language—and the exact wording varies, as does the need to initial or sign in multiple places. Some states require a separate informed consent for telemedicine (often in addition to the standard consent to be seen).
Currently, 29 states include some sort of telemedicine informed consent requirement in their statutes, administrative codes and/or Medicaid policies. You should always determine in advance what the policies and requirements are for your state. The Center for Connected Health Policy (CCHP) (http://www.cchpca.org) and the American Telemedicine Association (ATA) (http://www.americantelemed.org/home) provide overviews of current state policies.
Some basics to keep in mind, at least for an initial encounter and maybe periodically thereafter if there are additional visits, include:
- Inform patients of their rights when receiving TM, including the right to stop or refuse treatment
- Tell patients of their own responsibilities when receiving TM treatment
- Have a formal complaint or grievance process to resolve potential ethical concerns or issues that might come up
- Describe potential benefits, constraints, risks (privacy, security)
- Inform patients of what will happen in case of technology or equipment failures during TM sessions, state contingency plan
- Inform patients & obtain their consent when students or trainees observe the encounter
- Obtain patient consent prior to any recording of the encounter (note that the recording will be made available upon request and that release of the recording shall require written patient authorization or court order)
- Adhere to all applicable laws and regional and local practices as to Patient Informed Consents & Disclaimers
- Set appropriate expectations regarding TM encounters, including, for example, prescribing policies, scope of service, communication, and follow-up
- To reduce risk of overprescribing, follow evidence-based guidelines as well as all federal, state and local regulations
- Have a procedure in place for patients who don’t wish to sign the consent forms or receive care via telemedicine
It is useful to periodically check the status of your state’s current laws and Medicaid policies on informed consent for telemedicine either via the CCHP, ATA or your regional Telehealth Resource Center. Your state may have specific policies on what provider types may obtain the informed consent (especially in the case of behavioral health) and what items the informed consent must include.
And even if your state doesn’t have specific rules on informed consent for telemedicine, keep in mind that informed consent not only informs and protects the patient, but also, according the MedPro Group, protects the provider from the risk of facing consent-based negligence claims.
Much of this is common sense, but every now and then it helps to remind everyone!
Elizabeth Krupinski, Ph.D. is a Professor at Emory University in the Department of Radiology & Imaging Sciences and is Vice-chair of Research.. She is Associate Director of Evaluation for the Arizona Telemedicine Program and Director of the SWTRC. She has published extensively in these areas, and has presented at conferences nationally and internationally. She is Past Chair of the SPIE Medical Imaging Conference, Past President of the American Telemedicine Association, President of the Medical Image Perception Society, and Past Chair of the Society for Imaging Informatics in Medicine. She serves on a number of editorial boards for both radiology and telemedicine journals and is the Co-Editor of the Journal of Telemedicine & Telecare.