Patient Decision Aids: A Case for Certification at the National Level in the United States.

Patient decision aids enable patients to be better informed about the potential benefits and harms of their healthcare options. Certification of patient decision aids at the national level in the United States is a critical step towards responsible governance-primarily as a quality measure that increases patients' safety, as mandated in the U.S. Patient Protection and Affordable Care Act (PPACA). Certification would provide a verification process to identify conflicts of interest that may otherwise bias the scientific evidence presented in decision aids. Certification also benefits clinicians who may otherwise face malpractice claims based on harm to patients caused by possible reliance on patient decision aids that are inaccurate, incomplete, or presented in a manner that biases the patient's decision. Existing work by the International Patient Decision Aid Standards Collaboration could guide the establishment of a certification process within the U.S. This article argues for national certification of patient decision aids and discusses how that may be achieved. Copyright 2015 The Journal of Clinical Ethics. All rights reserved.