clinical decision support FDA

FDA’s support of AI in telemedicine
By Bradley Merrill Thompson | 04:46 pm | April 24, 2020
Epstein Becker & Green's Bradley Merrill Thompson describes the agency's current trajectory for regulation of patient-facing and provider-facing telehealth products that incorporate AI.
FDA expands use of vital sign monitors to enable remote care, modifications during COVID-19 emergency
By Dave Muoio | 05:50 pm | March 20, 2020
The temporary policy also extends to some clinical decision support software used in conjuction with these remote monitor devices.
FDA releases revised draft guidance on CDS software, final guidelines on ‘device’ definitions for software such as wellness apps
By Dave Muoio | 03:50 pm | September 26, 2019
The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act.
FDA permits marketing of AI software that autonomously detects diabetic retinopathy
By Dave Muoio | 12:10 pm | April 12, 2018
In-Depth: Anticipating FDA Regulation of Pharmaceutical Apps
By MHN Staff | 07:52 am | February 27, 2015