The mHealth Regulatory Coalition, in a partnership with U.S. Food & Drug Administration, mHIMSS, the Wireless Life Sciences Alliance and several other mHealth groups, is solving that problem with a series of meetings at universities around the country. "The MMA Roadshow: Managing App Development under FDA Regulation," began this week at the University of Illinois in Chicago and has seven more scheduled events through June.
Bradley Merrill Thompson, a partner with Epstein Becker Green, adviser to the MHRC and chairman of the roadshow's steering committee, said the goal of the roadshow "is to advance patient care by encouraging the development of apps at the higher benefit/high risk end of the spectrum."
"Mobile apps offer incredible opportunities to improve the quality of care, as well as its effectiveness and efficiency, and so far developers have barely scratched the surface," he said. "We hope to help more companies enter this space." ...
"Many of the medical-related apps developed so far address low risk needs such as basic tracking and trending of health data, but there are huge opportunities to use apps for more serious purposes such as managing cardiovascular disease," he said. "However, with these greater opportunities come greater risk and the likelihood of FDA regulation. The consortium wants to help traditional medical device companies and IT companies looking to bring their technology to healthcare understand the process for innovating in this regulated space. The MMA Roadshow will help demystify the FDA requirements for new entrants, and identify best practices among those already producing regulated apps. At the same time, the consortium hopes to spur economic development in an area where the U.S. has a clear advantage globally."