FDA Provides Guidance on Remote Data Collection for Clinical Investigations
Health IT Security
The Food and Drug Administration (FDA) released draft guidance offering recommendations for stakeholders surrounding the use of digital health technologies (DHTs) for remote data collection in clinical investigations of medical products.
The FDA is requesting feedback and comments on the draft by March 22, 2022. The latest guidance falls in line with a collection of recent drafts and best practices from the FDA concerning medical devices.
Using DHTs for remote data collection enables researchers to...