FDA pledges ‘efficient regulation’ of mobile health apps

Dive Brief:

• FDA brass is vowing to develop a regulatory framework for mobile medical apps that supports innovation and commercialization of digital tools while protecting patient health, top officials asserted in a JAMA viewpoint.
• Software-based health technologies such as mobile apps, often called software as a medical device (SaMD), are increasingly used by providers and their patients to promote wellness, diagnose and treat diseases and manage chronic conditions.
• In the viewpoint, FDA Commissioner Scott Gottlieb, Center for Devices and Radiological Health chief Jeffrey Shuren and Bakul Patel, associate director for digital health at CDRH, highlight the steps the agency has taken to support development of and access to mobile medical apps.

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