On Thursday, April 23 and Saturday, April 25, Tonya Newman presented at the Diabetes Technology Society's 2020 Virtual Hospital Diabetes Meeting. Both presentations focused on compliance and noncompliance of applicable FDA regulations, as well as tort exposures and other risks to consider.
The first presentation, "Data Management of CGM and Closed Loop Systems – Legal Implications," discussed using continuous glucose monitors in the hospital (off-label use) and developing software to summarize and store the data gathered from those monitors.
The second presentation, "Don’t Give in to Sweet Talk: Consider Risks Carefully When Developing and Sharing Insulin Dosing Software," discussed hospitals developing their own insulin dosing software programs and possibly sharing them with other hospitals, all without FDA approval of the software.
Click here for more information on this event.