Defining Surgical Terminology and Risk for Brain Computer Interface Technologies.

With the emergence of numerous brain computer interfaces (BCI), their form factors, and clinical applications the terminology to describe their clinical deployment and the associated risk has been vague. The terms "minimally invasive" or "non-invasive" have been commonly used, but the risk can vary widely based on the form factor and anatomic location. Thus, taken together, there needs to be a terminology that best accommodates the surgical footprint of a BCI and their attendant risks. This work presents a semantic framework that describes the BCI from a procedural standpoint and its attendant clinical risk profile. We propose extending the common invasive/non-invasive distinction for BCI systems to accommodate three categories in which the BCI anatomically interfaces with the patient and whether or not a surgical procedure is required for deployment: (1) -BCI components do not penetrate the body, (2) -components are penetrative, but not deeper than the inner table of the skull, and (3) -components are located within the inner table of the skull and possibly within the brain volume. Each class has a separate risk profile that should be considered when being applied to a given clinical population. Optimally, balancing this risk profile with clinical need provides the most ethical deployment of these emerging classes of devices. As BCIs gain larger adoption, and terminology becomes standardized, having an improved, more precise language will better serve clinicians, patients, and consumers in discussing these technologies, particularly within the context of surgical procedures.