FDA Plans Oversight for AI Medical Devices, Addressing Bias

As artificial intelligence and machine learning are included in an expanding array of medical devices, concerns about the algorithms’ lack of transparency and potential bias driving patient outcomes have led the Food and Drug Administration to tackle the issue with a multipronged approach.
The FDA announced an initial plan in January, outlining five actions the agency aims to take. These include a transparent, patient-centered approach, the establishment of new pilot programs to enable real-world performance monitoring and the development of a regulatory framework.
Among the greatest benefits…