Apple and the FDA discussed Apple’s interest in including medical sensors in mobile devices, according to a report from Apple Toolbox, which filed a Freedom of Information Act request to gain insight into Apple’s December meeting with the FDA. The response notes that “[w]ith the potential for more sensors on mobile devices, Apple believes there is the opportunity to do more with devices, and that there may be a moral obligation to do more.” It’s also explained that while sensors would not necessarily mean a device must be reviewed by the FDA, the FDA would likely regulate any software that uses those sensors for medical purposes.
A glucometer, which measures blood sugar level, was cited as a specific example — it would be regulated if the software was marketed toward diabetics, under the label of diagnostic software. If only used to monitor blood sugar for nutritional reasons, a glucometer could be unregulated.
Apple also received guidance for Mobile Medical Apps, which was likely a stand-in name for the company’s now announced HealthKit. The FDA noted that “Apple will work closely with FDA as they develop future products.” It’s widely believed Apple will include biometric sensors in its upcoming iWatch.