Another great step from the #DigitalHealth arm of the FDA . They just issued a guidance about regulating medical products that contain several functions. Some of those functions are subject to FDA’s regulatory oversight as medical devices, while others are not. I read the whole thing so you don't have to. When they regulate a medical device, the so-called "other functions" may jeopardize the cybersecurity, reliability or accuracy of the device. So they want to make sure that those other functions are also regulated, and the industry is aware of the dangers and risks so the FDA can have a better oversight over such devices too. As technologies get more advanced with artificial intelligence-based analysis, using smartphones or other connected devices, it was time to address this so patients and medical professionals can still use such technologies with trust. The best example they mention at the end is about a smartphone app that detects skin cancer from photos of suspicious lesions of moles. They describe that the quality of the photo a phone camera can make significantly shapes the outcome of the analysis. The manufacturer of the app should document how the camera impacts their app's accuracy. Excellent step forward! #FDAregulation #HealthcareRegulation …see more