Technological advancements in healthcare have helped improve access to, options for, and convenience of care. Healthcare delivered via telecommunication technology (telehealth), has become an increasingly popular and viable option for patients, particularly as a result of the COVID-19 pandemic. Yet, even with these advancements, certain aspects of traditional medical care remain vital, including informed consent.
Informed consent is a process that is used to educate patients about proposed treatments and procedures, their potential benefits and risks, and alternative options. The level of detail involved in the informed consent process should depend on the complexity of the procedure or treatment and its associated risks. Minor procedures may require only a simple discussion of risks, while complicated procedures will likely involve a more detailed process. Regardless of the scope of informed consent, the process plays a crucial role in patients’ rights to autonomy and to make educated decisions about their healthcare.
The importance and value of informed consent applies to telehealth just as it does to traditional, in-person medical care. However, in telehealth, the informed consent process also should take into account risks specific to the delivery of care using telecommunication technologies.
A Health Law Advisor article addressing informed consent in telehealth states that “in the practice of telehealth, reliance on imperfect technological tools, as well as the ‘distance’ factor, can propel otherwise routine treatments into a higher risk category.”1 Specifically, risks associated with telehealth include technological glitches and failures (including transmission errors), technology-related privacy and security concerns, and lack of hands-on patient evaluation.
When telehealth became a feasible option for healthcare delivery, some states implemented informed consent laws specifically addressing telehealth. However, like other aspects of telehealth regulation, informed consent laws vary among states. For example, some states may require written informed consent, while others permit verbal consent.
|COVID-19 and Telehealth|
As a result of the COVID-19 pandemic, some states waived or relaxed their requirements related to telehealth-specific informed consent, such as not requiring providers to obtain consent for each encounter. These waivers will likely end when the pandemic is no longer considered a public health emergency.2
Even in the absence of state guidance, telehealth providers should carefully consider their informed consent processes because “failure to properly obtain a patient's informed consent before initiating telehealth services can increase a provider's risk of facing consent-based negligence claims . . .”3
Whether developing a separate informed consent process or modifying an existing process to cover telehealth, healthcare providers should consider including the following elements (in addition to any state-required information):
- The names of all involved healthcare providers with their credentials and locations, as well as any other staff that may help facilitate the telehealth service
- A description of the telehealth service that will be performed and the technology that will be used
- Alternative options for treatment and care
- Any risks specifically related to the electronic nature of the care delivery (e.g., technology disruptions, failures, or limitations)
- Specific security and privacy measures that have been implemented as well as any increased privacy risks relative to the telehealth technology
- A plan for ongoing care, including details about who is responsible for various aspects of the patient’s care
- A plan for alternative care in the case of an emergency or technological malfunction
All providers involved in the telehealth program should have a clear understanding of the informed consent process, and — as with traditional informed consent — the process should be documented in each patient's health record.
To learn more about state-specific requirements for telehealth and informed consent, see the Center for Connected Health Policy’s Consent Requirements webpage. For more risk management strategies related to the informed consent process, see MedPro Group's Risk Management Strategies for Informed Consent guideline.
1 Odom, B. (2013, June 19). Proactively approaching telehealth informed consent. Health Law Advisor. Retrieved from www.healthlawadvisor.com/2013/06/19/proactively-approaching-telehealth-informed-consent/
2 Center for Connected Health Policy. (n.d.). COVID-19: Easing consent requirements. Retrieved from www.cchpca.org/topic/easing-consent-requirements/
3 Odom, Proactively approaching telehealth informed consent.
This document does not constitute legal or medical advice and should not be construed as rules or establishing a standard of care. Because the facts applicable to your situation may vary, or the laws applicable in your jurisdiction may differ, please contact your attorney or other professional advisors if you have any questions related to your legal or medical obligations or rights, state or federal laws, contract interpretation, or other legal questions.
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