But a bill set to be introduced in the U.S. House of Representatives later this month aims to smooth the agency’s evaluation process. The Healthcare Innovation and Marketplace Technologies Act (HIMTA) would establish a special Office of Mobile Health at the FDA to provide recommendations on mobile health app issues. It would also create a mobile health developer support program at the Department of Health and Human Services to help app developers make sure they are operating within privacy regulations, including the federal law HIPAA that sets privacy standards.
"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," Rep. Mike Honda, D-Calif., who is introducing the bill, said in a statement. “Why have the principles of Silicon Valley, which I represent – competition, innovation, and entrepreneurship – not fully manifested themselves in the healthcare information technology space? This bill gets us closer to that space.”
Diabetes is managed by patients with multiple devices, meters, cgms, pumps, and logs of food, working out and other life activities. To be meaningful diabetes mobile apps will need to deal with more than one device. To me that is more relevant than the structure of the regulatory office.
(edited to add) I would suggest that we keep an eye open to closed loop A.P. and to get there maybe a good step is an open loop app where users are involved in the process but supported by an app that integrates information from multiple devices.