Dozens of Currently Available Dermatology Mobile Apps May Fall Outside FDA’s “Enforcement Discretion” Safe Harbor

Perhaps 27% of the 229 dermatology-related mobile applications (apps) that are available today may be subject to FDA regulation despite the agency’s "enforcement discretion" safe harbor, which exempts most mobile apps that "pose minimal risk to consumers." A study by Ann Chang Brewer, M.D., of the University of Arizona, Phoenix, and colleagues, published today in JAMA Dermatology ((JAMA Dermatol. Published online September 25, 2013. doi:10.1001/jamadermatol.2013.5517), identified 229 dermatology-related apps in several categories, including: general dermatology reference (61), self-surveillance/diagnosis aids (41), disease guides (39), educational aids (20) and sunscreen/UV (ultraviolet light) recommendations (19). Of the 229 apps, more than half were free. The following table from that study gives the percentages: According to FDA’s Final Guidance on Mobile Medical Applications (here), "FDA intends to exercise enforcement discretion" for mobile apps that:Help patients (i.e., users) self-manage their disease or conditions without providing specific treatment or treatment suggestions;Provide patients with simple tools to organize and track their health information;Provide easy access to information related to patients’ health conditions or treatments;Help patients document, show, or communicate potential medical conditions to health care providers;Automate simple tasks for health care providers; orEnable patients or providers to interact with Personal Health Record (PHR...
Source: Pharma Marketing Blog - Category: Pharma Commentators Tags: mobile medical app FDA Legal/Regulatory dermatology Source Type: blogs