by Sarah Fellay
American Enterprise Institute
August 05, 2014
Groundbreaking mobile health applications, such as AliveCor’s iPhone-powered electrocardiogram and Proteus’s Digital Health Feedback System, have the potential to reduce health care costs and minimize human error. But US government agencies—particularly the US Food and Drug Administration (FDA)—are not clearly defining what applications should be regulated, who should be regulating them, and how their regulation will be enforced, deterring investors and delaying the applications’ introduction to the market. The FDA can help the United States regain its lead in the mobile health sector by working to streamline the regulatory process and promote innovation, increase its collaboration with the private sector, and reevaluate its risk-based framework.



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