FDA Regulations of AI-Driven Clinical Decision Support Devices Fall Short

We are entering a new era of computerized clinical decision support (CDS) tools. Companies are increasingly using artificial intelligence and/or machine learning (AI/ML) to develop new CDS devices, which are defined by the US Food and Drug Administration (FDA) as software used in disease prevention, diagnosis, or treatment. Recognizing the potential implications for clinical practice, the 21st Century Cures Act enjoined the FDA to regulate these new devices.
Source: JAMA Internal Medicine - Category: Internal Medicine Source Type: research