FDA digital health regs: 'smart' or innovation killer?
This article was originally published in Clinica
Executive Summary
In the new age of digital health, whether it’s innovation in using data from electronic health records (EHRs), delivering care via telemedicine, computing in the cloud or providing information with mobile medical apps, the FDA wants to engage "in smart regulation." This involves knowing when and how to regulate, said Dr Jeffrey Shuren, director of the agency's Center for Devices and Radiological Health.