Sep 21, 2012
It’s not just the US Food and Drug Administration mulling over how to regulate mobile medical applications these days. The US Federal Trade Commission (FTC) has also recently come out with guidelines for medical app developers targeting advertising and privacy issues.
The FTC recommendations cover basic legal requirements that medical app manufacturers must meet in order to market their products, introducing obligations for these companies to be met along with FDA medical device registration requirements.
Key FTC guidelines include:
- Truthful advertising claims consistent across websites, app stores and within apps themselves
- Clear disclosure of key information backing up developers’ claims
- Establishing privacy protections at the outset
- Obtaining consent from patients or users before collecting sensitive information
- Ensuring secure patient/user data storage and management
Although a definitive FDA regulatory approach to mobile medical apps remains in the works, guidance from the FTC on how app developers should meet additional US legal requirements should provide a clearer—if not yet altogether clear—roadmap to compliance and commercialization in the US.
Author
- Stewart Eisenhart