USA – Action needed on FDA regulation of AI-based medical devices

The FDA’s outlined framework and action plan are steps in the right direction, but we need to ensure that inaction or delayed response in addressing regulation of AI and ML do not stall innovation

After lagging other sectors for years, the era of artificial intelligence (AI) in healthcare is dawning as its use is becoming more prevalent in a variety of applications — from medical imaging and ophthalmology, to remote monitoring and leveraging electronic health records (EHRs) to identify potential risk for chronic diseases or complications. Medical applications of AI are becoming increasingly important because they can deliver significant benefits. These applications can assist with clinical decision making by analyzing data quickly to deliver faster, better insights for diagnosis and treatment. They can also drive greater efficiency for providers by automating tedious and time-consuming administrative tasks…