Can You Diagnose Me Now? A Proposal to Modify the FDA’s Regulation of Smartphone Mobile Health Applications with a Pre-Market Notification and Application Database Program

Abstract

Advances in mobile technology continually create new possibilities for the future of medical care. Yet these changes have also created concerns about patient safety. Under the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has the authority to regulate a broad spectrum of products beyond traditional medical devices like stethoscopes or pacemakers. The regulatory question is not if the FDA has the statutory authority to regulate health-related software, but rather how it will exercise its regulatory authority. In September 2013, the FDA published Final Guidance on Mobile Medical Applications; in it, the Agency limited its oversight to a small subset of medical-related mobile applications, referred to as “mobile medical applications.” For the Final Guidance to be effective, the FDA must continue to work directly with all actors—including innovators, doctors, and patients as the market for mobile health applications continues to develop. This Note argues that the FDA should adopt a two-step plan—a pre-market notification program and a mobile medical application database—to aid in the successful implementation of its 2013 Final Guidance. By doing so, the FDA will ensure that this burgeoning market can reach its fullest potential.