Journal-based CME Course: Who, If Not the FDA, Should Regulate Implantable Brain-Computer Interface Devices?

Activity ID

10819

Expires

September 1, 2024

Format Type

Journal-based

CME Credit

Fee

$30

CME Provider: AMA Journal of Ethics

Description of CME Course

Implantable brain-computer interface (BCI) and other devices with potential for both therapeutic purposes and human enhancement are being rapidly developed. The distinction between therapeutic and enhancement uses of these devices is not well defined. While the US Food and Drug Administration (FDA) rightly determines what is safe and effective, this article argues that the FDA should not make subjective, value-laden assessments about risks and benefits when it comes to approval of BCIs for therapy and enhancement. This article also argues that determining BCIs’ benefits to society requires deliberations on values that the FDA is neither accustomed to making nor qualified to make. Given the inadequacy of the FDA’s safe-and-effective standard to judge devices spanning the spectrum of therapy to enhancement, this article argues that BCI regulation should not be overseen by the FDA.

Disclaimers

1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.

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More Information

Commercial Support?

NOTE: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement. Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Self-Assessment Program Requirements.

General Information on CME Activity

Educational Objectives

1. Explain a new or unfamiliar viewpoint on a topic of ethical or professional conduct
2. Evaluate the usefulness of this information for health care practice, teaching, or conduct
3. Decide whether and when to apply the new information to health care practice, teaching, or conduct

Keywords

Ethics, Neurology

Competencies

Medical Knowledge, Professionalism

CME Credit Type

AMA PRA Category 1 Credit

DOI

10.1001/amajethics.2021.745