Developing and Implementing an Effective Telemedicine Informed Consent Form

By on May 10, 2016

The search by consumers, payers and providers for more efficient, effective and convenient care delivery models has led to an explosion of technological innovation in the health care sector. This explosion has supported the increased use of telemedicine by providers to reach patients who were previously out of reach, and to provide more timely and cost-effective care.

With the use of telemedicine technologies comes a responsibility on the part of providers to educate and inform patients on the benefits, and more importantly, on the risks associated with receiving care via telemedicine. Like any other care setting, compliance with this responsibility serves the dual purpose of providing consumers with the information needed to make an informed decision about their care, but also mitigates the provider’s potential liability exposure from medical malpractice claims.

In addition, obtaining the patient’s informed consent may be required under the law of the state in which the patient is located at the time that the telemedicine service is provided. A significant and growing number of states require physicians to obtain the informed consent of patients prior to rendering care to the patient via telemedicine. The cause of this growing trend is, at least in part, due to the adoption of the Federation for State Medical Board’s Model Policy for the Appropriate Use of Telemedicine Technologies in the Practice of Medicine, which provides guidance on the appropriate use of telemedicine technologies to state medical boards and encourages states to require telemedicine providers to obtain patient informed consent.

States have adopted varying approaches to telehealth-specific consent laws. States with informed consent requirements often regulate when consent is required, the format in which consent is delivered and obtained (i.e., written or verbal), and/or the content of the consent. However, even when not required by law, obtaining the informed consent of patients prior to engaging in a telemedicine encounter is a “best practice.” Providers should take a proactive approach to the informed consent process to decrease the likelihood of miscommunications with patients that may lead to medical malpractice suits. From a risk standpoint, providers who implement an informed consent process with the components described further below will be better positioned to engage patients in an effective and productive telemedicine consultation and less exposed to malpractice liability.

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An effective telemedicine informed consent form will have many of the same characteristics of the consent forms typically signed by patients prior to receiving care in a traditional physician-patient encounter, but with a few importance nuances. Below are suggestions for developing and implementing an effective telemedicine informed consent form.

  1. Provide the right information. The objective of the informed consent form should be to clearly and accurately disclose all of the material facts necessary for the patient to make an informed decision about receiving telemedicine services. At a minimum, informed consent forms should identify the name of the telemedicine provider and include any terms required under the laws of the state in which the patient is located. In addition, the form may include the following:
  •  Direction for the patient to contact 911 emergency services and to proceed to his/her nearest emergency department for emergency conditions
  • A description of the telehealth process (g., which technologies will be used, how the provider and patient will communicate using this technology)
  • A summary of the services that may or may not be provided via telemedicine
  • A description of the expected risks and benefits of telehealth services that is easy to understand (e., not full of undefined or complex legal and medical terms)
  • Information about what will happen if the telemedicine technology fails
  • Information about the patient’s potential financial responsibility for costs associated with the telemedicine service (if applicable)
  • Other information necessary for the patient to have a complete understanding of the telehealth process
  1. Disclaim potential liability. Providers should also assess the benefits of including provisions that disclaim and limit the provider’s liability for any harm caused by telemedicine equipment or technology failures, or injuries caused by the patient’s failure to fully and accurately describe the medical condition for which s/he is seeking medical assistance.
  2. Two forms of communication are better than one. Depending on the nature of the encounter and the relationship between the provider and patient, providers should consider whether it is appropriate to communicate the content of the consent both verbally and in writing.
  1. Obtain the patient’s agreement. Whenever possible, it is best to obtain the written or verbal acknowledgement of the patient to the terms of the informed consent, rather than simply providing them with a copy. Where the patient signs or agrees to the terms and conditions of the consent (electronically or on paper), the form should clearly state that the patient acknowledges that he or she has read, understands and consents to all of the terms of the consent form.
  1. Include a copy in the patient’s medical record. Informed consents obtained in connection with an encounter involving telemedicine technologies should be filed in the patient’s medical record. The date (and time when possible) that the patient issued his or her consent should also be documented.
Lisa Mazur
Lisa Mazur advises health care providers and technology companies on a variety of legal, regulatory and compliance matters with a particular focus on digital health topics, including telehealth, telemedicine, mobile health and consumer wellness. Lisa advises a variety of health care providers and technology companies involved in “digital health,” including assisting clients in developing and implementing telemedicine programs by advising on issues related to professional licensure, scope of practice, informed consent, prescribing and reimbursement. Lisa helps clients identify and understand the relevant legal issues, and develop and implement practical, forward-thinking solutions and strategies that meet the complex and still-evolving digital health regulatory landscape.  Read Lisa Mazur's full bio.




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