New FDA Comment Authored by BIG IDEAs Lab

The Duke BIG IDEAs Lab has published another public comment to the FDA on patient safety and best practices for non-device health software!

As consumer health software, wearables, and AI become increasingly integrated into how people understand and act on health information, patient safety depends on more than whether a technology causes direct physical harm. The quality of the underlying data, how outputs are communicated, and how those outputs influence behavior all matter.

In this comment, we highlight several areas for consideration, including:
1. Clearer definitions across FDA policies for wellness and healthy-lifestyle software
2. Greater attention to the provenance and validity of data used by software
3. Risks of automation bias and misplaced trust in AI-generated interpretations
4. Informational, behavioral, and privacy risks associated with consumer health technologies

As these technologies evolve, health policy has an important role to play in balancing innovation with appropriate safeguards for patients.

Huge thanks to the authors for their work: Dr. Jessilyn Dunn, Stephanie Sullivan, Perisa Ashar, Annika Kumar, Bill Chen

Read the full comment here: https://www.regulations.gov/comment/FDA-2018-N-1910-0395