By Lisa Johnston
New products on display at the American International Toy Fair, held in N
Arlington, Va. – The Consumer Electronics Association (CEA) announced its sponsorship of an educational program series called the “Mobile Medical Apps (MMA) Roadshow: Managing App Development under FDA Regulation.”
CEA is joining a consortium of six leading universities, more than a dozen industry trade associations and professional societies, and the U.S. Food and Drug Administration (FDA). The MMA Roadshow events, taking place at universities across the U.S., aims to demystify the FDA requirements for new-entrant app developers and identify best practices among those already producing regulated apps.
“There are huge opportunities for healthcare providers to monitor and diagnose remotely, and for individuals to take a major role in their own healthcare with fewer trips to the doctor,” said Gary Shapiro, president and CEO, CEA. “Consumers are increasingly using electronics to manage their health, and we are thrilled to support a program that aims to spur innovation by bringing more mobile apps into the healthcare space.”
Late last year, the FDA published its final guidance on mobile medical apps, clarifying that the administration regulates the higher-risk portion of mobile apps, those intended for use in the diagnosis or treatment of diseases or other conditions. Since then, companies have been examining the final guidance in an effort to determine how it impacts their particular apps and business plans.
“Mobile apps offer incredible opportunities to improve the quality of patient care, as well as its effectiveness and efficiency, and so far developers have barely scratched the surface,” said Bradley Merrill Thompson, the chairman of the steering committee for the program. “We hope to encourage and help more companies enter this space.”
With a focus on entrepreneurs and innovators, the MMA Roadshow and its content are both geographically and economically accessible. The consortium members, industry trade groups and professional societies all volunteered to do their part to connect these educational opportunities with budding entrepreneurs. Consortium members collectively have hundreds of thousands of members interested in mobile health, representing the vast majority of technology developers in this mobile space, and hope to spur economic development in an area where the U.S. has a clear advantage globally.
The first workshop took place today, Jan. 16, at the University of Illinois at Chicago. For more information about the program, dates, agenda and participating organizations, visit mHealthRegulatoryCoalition.com/
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