Alliance Calls on FDA to Seek Stakeholder Input on Mobile Medical Apps Guidance
Washington, D.C. (June 26, 2012) – Today, the Application Developers Alliance applauded Congress directing three federal agencies to ensure that government regulation of medical mobile apps “promotes innovation, protects patient safety, and avoids regulatory duplication.” The Alliance also urged the Food and Drug Administration (FDA) to convene quickly a Congressionally authorized working group of external stakeholders. That working group should ensure that the three agencies – including the National Coordinator on Health IT and the Federal Communications Commission – have access to app developer expertise when developing their strategic plan.
“App developers are building amazing new tools that help patients improve their health, researchers compile better data, and medical professionals improve care and reduce costs,” said Jon Potter, President of the Application Developers Alliance. “Congress said streamlined regulation promotes innovation and patient health. Duplicative regulation slows innovation, reduces investment, and diminishes patient benefits. It also harms app developers while failing to help patients.”
Congress directed the agencies’ coordination and authorized the working group in Section 618 of the just–passed Food and Drug Administration Safety and Innovation Act.
“The Alliance, on behalf of more than 7,500 members, looks forward to working with FDA, the FCC, and ONC over the next several months to streamline regulation,” said Potter.