FDA Draft Guidance: Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

This document from the FDA acknowledges a maturity in the clinical trial industry demonstrating that digital health technology is now a key component in clinical investigation. First, they emphasize fit-for-purpose:

"Sponsors should ensure that a DHT is fit-for-purpose (i.e., that the level of validation associated with the DHT is sufficient to support its use and interpretability in the clinical investigation)."

The draft document also points out the need for design considerations, such as, participant's willingness to use the device or software, such as, a wearable, battery life, alerts, data storage capacity, data privacy, etc. They also emphasize the Verification, Validation, and Usability of Digital Health Technologies. NODE Health has a standard approach to validation and is a good resource for this. Validation may vary whether the DHT is sensor-based, software based or via a "general purpose computing platform." Interoperability is another key factor in design and here there are standards, such as, the Continua Design Guidlines.

The draft guidance also discusses clinical endpoints. Here the Digital Medicine Society has taken the lead in defining many of these endpoints. Risks and record retention are also discussed.

It is encouraging to see this guidance and the broader use of digital health in clinical trials. Organizations like the Digital Therapeutics Association, the Digital Medicine Society and NODE Health (Network of Digital Evidence) are helpful resources related to this document.