Safeguarding Data Security in the Era of Imaging mHealth

Mobile health (mHealth) technologies stand poised to find broad application in the radiology space. They hold considerable promise for millions of patients in the United States, enabling at-home imaging and augmenting clinical decision-making. However, they often lie outside the ambit of FDA regulation and process vast quantities of data largely unprotected by HIPAA. This article explores features of federal mHealth policy relevant to imaging practice and advocates for greater regulatory clarity to assist radiologists, developers, and ultimately, patients.