Informed Consent to Artificial Intelligence in Health Care

The doctrine of informed consent posits that the patient is entitled to understand:

  • What the doctor proposes and why;
  • The risks and benefits of that proposed course of action;
  • The available alternatives and the risks and benefits of each of those, including doing nothing.

In Virginia, the duty of the physician, like all other aspects of standard care, is defined by the habit of the profession—what other “reasonably prudent” providers in Virginia of the same field or specialty would disclose in similar circumstances at the time the case arose.

But what if the care proposed includes a technology so new, and used at present in such limited circumstances, that a specialty’s “habit” is hard to identify, and pertinent risks may be recognized only incompletely? What if too many questions a patient might ask the current state of knowledge does not permit a confident answer? These are some of the problems facing health care professionals beginning to use artificial—what the American Medical Association prefers to call “augmented”—intelligence.

An Evolving Solution

In its current state of development, the law gives no clear answer. It may help, however, to consider at least some of the questions pertinent to the inquiry. Articulating the issues is not sufficient, but may be necessary to evolving a solution.

Must the doctor:

  • Explain how AI works?
    What if no one, not even the engineers who built it, can do that?
  • Determine whether the system’s training data were representative of the relevant patient population?
  • Describe the predictive accuracy and error rates of the system?
    Across demographic groups?
  • Distinguish between roles played by humans and those by AI?
  • Compare results with AI versus those with humans?
    Even if data are scarce or nonexistent?
  • Disclose AI recommendations he disapproves of?

This list is by no means complete, and as the technology advances new issues will likely emerge. In the meantime, at least until legislation or regulations are enacted, or there is guidance from case law, disclosures comparable to those made by others in the relevant specialty ought to suffice to meet legal requirements.

Attorneys and practice areas related to this topic include:

Joseph P. McMenamin
Health Care

This item has been provided as an informational service and does not constitute legal counsel or advice, which can only be rendered in the context of specific factual situations. If a legal issue should arise, please contact an attorney listed or retain the assistance of other competent legal counsel. Case results depend on a variety of factors unique to each case and results do not guarantee or predict a similar result in any future case undertaken.