AMIA Airs CDS Concerns to FDA

WASHINGTON – The American Medical Informatics Association argues that when it comes to oversight of clinical decision support systems, the most critical factor in determining the risk classification of different types of software is whether the CDS is mediated by a human being or not.

Meryl Bloomrosen, AMIA's vice president for public policy and government relations, has offered those comments in response to the U.S. Food and Drug Administration's (FDA) invitation to participate in a public workshop related to FDA's Draft Guidance on mobile medical applications.