Medtechs need strategy to prevent bias in AI-machine learning-based devices: FDA

Jeff Shuren, director of the FDA's Center for Devices and Radiological Health, on Thursday called out the need for better methodologies for identification and improvement of algorithms prone to mirroring "systemic biases" in the healthcare system and the data used to train artificial intelligence and machine learning-based devices, speaking at an FDA public workshop on the topic. The medical device industry should develop a strategy to enroll racially and ethnically diverse populations in clinical trials. "It's essential that the data used to train [these] devices represent the intended patient population with regards to age, gender, sex, race and ethnicity," Shuren said. The virtual workshop comes nine months after the agency released an action plan for establishing a regulatory approach to AI/ML-based Software as a Medical Device (SaMD). Among the five actions laid out in the plan, FDA intends to foster a patient-centered approach that includes device transparency for users.