Catching Up with Convergence: Strategies for Bringing Together the Fragmented Regulatory Governance of Brain-Machine Interfaces in the U.S.

Abstract

After a decade of stalled innovation, the past five years have seen brain-machine interfaces (BMIs) make rapid advances through the convergence of ideas from and progress in multiple other emerging technologies. However, the sheer complexity of these neuro-technologies will produce a complicated and incomplete regulatory environment, which could delay the potential benefits and fail to manage the risks BMIs may create for patients or consumers. Regulating these neuro-technologies will demand managing risks at the intersection of safety, effectiveness, cyber-security, consumer protection, equity, data privacy, personal autonomy, and dual use. These convergent risks compound the thorny “pacing problem,” in which accelerating technological innovation overtakes public regulators and their efforts to understand and manage risks.

In the United States, the Food and Drug Administration (FDA) and Federal Trade Commission (FTC) already have authority to regulate some neuro-technologies. However, the agencies have jurisdiction over different subject matters which overlap and under lap in BMIs due to technological convergence. This convergence will ultimately create significant regulatory problems for BMIs and neuro-technologies generally. Managing the complexities of convergence in BMIs will require a policy response defined by early action, regulatory coordination, and political support from lawmakers.

Keywords: Administrative Law, Brain-Machine Interfaces, Coordination, Health Technology Assessment, Neuro-technologies, Regulation