Considerations for Healthcare Providers
Informed consent — a process that is used to educate patients about the potential benefits, risks, and alternatives to proposed treatments — is a crucial component of a patient's right to make decisions about his/her healthcare. As MedPro Group's Risk Management Strategies for Informed Consent guideline explains, "Any procedure that presents the possibility of material harm to a patient should not be undertaken until the informed consent process has been completed."
The importance of informed consent applies to care delivered via telemedicine just as it does to traditional medical care. However, in telemedicine, the informed consent process must also take into account risks specific to the delivery of care using telecommunication technologies. An article addressing informed consent in telemedicine 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 telemedicine include technological glitches and failures (including transmission errors), technology-related privacy and security concerns, and lack of hands-on patient evaluation.
As telemedicine has become a more viable option for healthcare delivery, some states have implemented informed consent laws that pertain specifically to telemedicine. However, like other aspects of telemedicine regulation, informed consent laws vary among states. For example, some states may require written informed consent, while others permit verbal consent.
Even in the absence of state guidance, telemedicine providers should carefully consider their use of an informed consent process. As the aforementioned article notes, "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..."2
Whether developing a separate informed consent process or modifying an existing process to cover telemedicine, healthcare providers may want to include (in addition to all standard and state-required informed consent information):
- The names of all involved healthcare providers and their credentials and locations, as well as any other staff that may help facilitate the telemedicine service
- A description of the telemedicine 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 telemedicine 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 telemedicine program should have a clear understanding of the informed consent process, and — as with traditional informed consent — the process should be documented in the patient's record.
For more risk management strategies related to informed consent, see MedPro Group's Risk Management Strategies for Informed Consent guideline.