For health IT firms, regulatory questions abound

Regulatory questions abound as companies and public agencies alike contend with the rising role that portable devices, Web-based computing and other fast-evolving technologies play in people’s care. From smartphone applications that count calories to for-medical-use-only products, such devices have complexity and expectations that vary wildly. So where will regulators draw the line? “In the near future, we plan to provide draft guidance for public comment prior to finalizing, which will provide clarity for manufacturers as they continue to develop innovative, health-related mobile apps,” a Food and Drug Administration spokeswoman wrote.