Patricia Flatley Brennan, Ph.D., R.N., Project HealthDesign National Program Director
I want to thank the FDA for the opportunity to comment on the draft guidance on mobile medical applications. The guidance certainly aims to clarify what types of mobile applications qualify as mobile medical applications, what types qualify as mobile health or wellness applications, and what types qualify as mobile medical devices. The issue I want to be sure you address is that the line between mobile medical applications and mobile health or wellness applications is not yet sufficiently clear.
Through Project HealthDesign, our 14 research teams have developed mobile applications that allow patients with chronic diseases to manage their health in new ways. Beyond our project, many well patients are beginning to use mobile health or wellness applications to actively maintain their health. The language of this guidance must reflect this new reality when delineating between these two groups of mobile applications.
I also encourage you to provide more examples of the types of mobile applications that fall into each of these two categories. Developers must be able to easily identify whether their applications will be subject to regulation as mobile medical applications. Without additional examples of the types of applications that fall into each category, developers’ uncertainty about the guidance might stifle the incredible innovation we’re seeing in this space. Furthermore, I urge you to implement a transparent process for updating the list of examples over time as the technology evolves.
This comment was submitted to the FDA in response to their draft guidance on mobile medical applications. To read the draft guidance, visit Regulations.gov.