Sep 27 2018

Informed Consent in Telemedicine

Telemedicine is defined in the Massachusetts General Laws as “the use of interactive audio, video or other electronic media for the purpose of diagnosis, consultation or treatment.” M.G.L. chapter 175, § 47BB.  It’s further defined in the Code of Massachusetts Regulations as “the provision of services to a patient by a physician from a distance by electronic communication in order to improve patient care, treatment or services.”  243 CMR 2.01. The use of telemedicine is intended not only to improve accessibility to health care in a way which increases efficiency in diagnosis and treatment, but also as a means to increase the speed of delivery with immediate access to care.

However, the provision of telemedicine raises additional, often heightened, duties to the standard of care.  Notwithstanding the promise of more efficient health care, telemedicine providers must remain particularly diligent in dedicating time to obtaining and documenting informed consent.  In deciding whether to accept a method of treatment, a patient is required to have “knowledge of the available options and risks attendant on each.”  See Harnish v. Children’s Hosp. Medical Center, 387 Mass. 152, 154.  In Massachusetts, “a physician owes to his patient the duty to disclose in a reasonable manner all significant medical information that the physician possesses or reasonably should possess that is material to an intelligent decision by the patient.”  Id. at 154-55.  A physician is thus liable when she or he “fails to divulge in a reasonable manner to a competent adult patient sufficient information to enable the patient to make an informed judgment whether to give or withhold consent to [a proposed care or treatment].”   Id.

The law and ethics of informed consent can be fairly complex.  Stated in its most basic terms, a physician is liable for lack of informed consent where a patient is harmed because certain risks associated with a method of treatment materialized and the patient should have been, but was not, warned about them.  Informed consent in a telemedicine encounter will then inherently include risks separate and in addition to the risks a provider would disclose in a traditional in-person encounter.  These separate disclosures may include the consulting physician’s name and location, disclosures about the use of videoconferencing technology to render the service, and the potential risks associated with the use of telemedicine services. A particular risk inherent to telemedicine that a provider would discuss is the potential for equipment or technology failure resulting in an inaccurate or incomplete diagnosis.

While telemedicine can have a positive overall effect on health care, it also creates additional avenues for potential malpractice liability.  Unlike other states, Massachusetts has not enacted any telemedicine-specific standard of care for informed consent. See generally Arizona, Ariz. Rev. Stat. § 36-3602(A); California, Cal. Bus. & Prof. Code § 2290.5; Kentucky, Ky. Rev. Stat. Ann. § 311.5975(1)(a); Oklahoma, Okla. Stat. § 36-6804; Texas, Tex. Occ. Code Ann. § 111.002. 

As a result, telemedicine providers should approach informed consent by considering what significant medical information she or he possesses, or should possess, about the provision of healthcare through electronic communication that would be material to an intelligent decision by the patient in deciding whether to accept treatment through telemedicine.  As with any treatment or surgery, maintaining evidence documenting informed consent in the patient’s medical record is crucial.  From both a best practices and risk perspective, appropriate informed consent should, at a minimum, include the following:

  1. The identification of the patient, the provider and the provider’s credentials, and the location of the patient and the location of the provider.
  2.  Discussion that the patient understands and agrees that the provider determines whether the condition being diagnosed and/or treated is appropriate for a telemedicine encounter.
  3.  That all medical reports resulting from a telemedicine consultation are part of a patient’s medical record.
  4. That the patient is entitled to all existing confidentiality protections under law, such as HIPAA and other federal and state privacy and security laws.
  5. That notwithstanding the privacy and security measures in place, such as data encryption and authentication protocols, there remain risks to privacy; and, as noted above,
  6. Risk of faulty technology caused by, among other potential sources, electromagnetic interference.

Telemedicine creates unique malpractices issues for health care providers.  From purely a risk perspective, it’s recommended that telemedicine providers ensure their malpractice insurance covers this method of treatment.  Further, if telemedicine providers have any questions or concerns about her or his practice of telemedicine, they should consult their respective risk managers or consult independently with legal counsel.

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